Newer AIDS Treatments Better, But More Expensive

Tackling AIDS One Person at a Time
The Cutting Edge: The Future of Preventing HIV and STDs
Boosting HIV Detection With a Quick Test
Lipodystrophy: A New HIV Complication?
Introduction to HIV
Nutrition and HIV Infection
Spermicides and Condoms: Not the Best Marriage?

Newer AIDS Treatments Better, But More Expensive   By: Eric Sabo

A combination of newer AIDS drugs is simpler to use and more effective than older medications, an international team of researchers has found. Patients who took a one-a-day treatment regimen that made use of a new drug, Viread, were more likely to control the virus compared to those who relied on the old-standby, AZT. The newer combination was also linked to fewer side-effects.

The results, published in The New England Journal of Medicine, fall in the wake of a disappointing government trial that was halted early because an easier treatment approach failed to help. In that study, patients who took periodic breaks from AIDS medications were twice as likely to see their disease progress compared to those who took the drugs continuously, which came as a surprise to National Institutes of Health researchers. Earlier trials suggested that AIDS could be controlled with less stringent medication use.

Still, the latest study comparing Viread to older drugs adds to an encouraging trend in managing AIDS. A decade ago, people with HIV had to take anywhere from 12 to 24 different pills a day, based on a rigorous schedule tied to the timing of meals. Now, patients may only need to take a couple of pills a day, with no food requirements.

"We should get that down to one pill by the end of the year," said Dr. Joel Gallant, an AIDS researcher at Johns Hopkins who led the study. "It's very impressive."
Gallant compared the newer drug combination to what has long been the standard of care in HIV. Half of the 500 patients received a Viread-based combination called Truvada, plus an additional drug, Sustiva. The others received Combivir (AZT plus 3TC), as well as Sustiva. The study was sponsored by the maker of Viread and involved patients who had not previously received anti-retroviral therapy.

Two years later, 80 percent of those who took the one-a-day Viread combo had undetectable levels of HIV, versus 70 percent who were on the twice-a-day AZT one. There were fewer complaints of nausea and fatigue in the group taking the newer combination. In contrast to those who took the older drugs, patients who took the newer treatments also had a higher number of disease-fighting cells.

Patients who are already responding well to the AZT combination should stay the course, Gallant said.

However, after a year of treatment, the researchers started noticing that more patients in the AZT group had significantly less fat on their lower limbs, which can lead to disfiguring changes in body shape over time.

"This is telling me, personally, that something is wrong," Gallant said. "But we still have to see what happens later."

In the meantime, Gallant said that most newly-diagnosed patients are better off with trying the newer combination. The major downside is cost. AZT is now available as a generic, making it far cheaper than the latest AIDS drugs, which can run several thousands of dollars a year. Gallant also warns that Viread has unique side-effects for people who have kidney problems.

But in both effectiveness and ease of use, Gallant said the latest combination appears to be best.

"This has a lot of relevance for people who are just starting therapy," he said.

Tackling AIDS One Person at a Time   By: Eric Sabo
The Centers for Disease Control released a report recently that would suggest a small vindication of Dr. Wafaa El-Sadr's many years of work. Out of 33 states that were looked at, the CDC found that the number of HIV cases among blacks has been dropping at a rate of five percent a year. They pointed to New York City as leading the way in reducing infections from intravenous drug use, a key part of what El-Sadr promotes at her AIDS program in Harlem.

"It's more complicated than that," says El-Sadr about this good news. From the large stack of the medical journals that sit on her desk, she cites studies which reveal an epidemic still in full force.

"AIDS is the number-one killer of young black women," she says. In gay black men, 45 percent may have HIV. "There's a lot of frightening statistics people need to be aware of," she warns.

El-Sadr says all of this matter-of-factly, as if there were a lot of work to do and no time for a pat on the back. Born in Egypt, she holds dual positions at Harlem Hospital and Columbia University, which has led to wide recognition of her pioneering AIDS efforts.
Commemorating World AIDS day last year, New York Mayor Michael Bloomberg singled out El-Sadr for her contributions in preventing HIV in women. "Dr. El-Sadr has impacted countless lives, offering care that goes beyond the clinic," commented her boss, Dr. Alan Rosenfield, who is the dean of Columbia's School of Public Health.

Yet there are no plaques on the wall. Her office sits in a narrow corner of Harlem Hospital, and on the first really cold day of fall, the heater is not working. Her visitor looks cold. "Do you need a coat?" she asks. "I have some extras."

Offering a Helping Hand
As the world takes stock in another World AIDS Day, El-Sadr continues to run her clinic with the same family care approach. The largely poor neighborhood around Harlem Hospital, comprised of small stores and run-down store fronts, has left El-Sadr and a small staff to care for those who might otherwise go ignored: drug users, recent immigrants and men and women just out of prison.

They arrive at her clinic for complex reasons, but all share a fear of being diagnosed with HIV, she says. What becomes quickly apparent to her patients is that someone cares. "They need to feel loved, not ashamed," says El-Sadr.

Being diagnosed with HIV is never easy to take, so El-Sadr makes sure that one of her staff walks each patient to the separate clinic where treatment begins.

Helping further are trained volunteers who have HIV themselves. "In their moment of shock, a counselor can turn to them and say, 'Look, I have HIV too,'" she explains. "It's very powerful."

Another powerful point is the dramatic turnaround in treating AIDS. A cocktail of drugs has transformed the disease into a more manageable condition, not unlike diabetes. "I've been seeing some of the patients for nearly twenty years," she says.

But she is quick to point out that people with HIV need as much support as they do medicine. "It's not all about the pills," she adds. The clinic offers a range of services, from spreading the word about prevention, to being there when no one else is around to help. "Continued support is what makes it all work," she says.

A Growing Family
Having had incredible success, or "luck" as she calls it, in getting her patients in Harlem the expensive care they need, El-Sadr has recently expanded her work to Africa and Asia. In modest clinics in Kenya and seven other countries, mothers with HIV are given lifesaving drugs to prevent transmitting the virus to their children. These countries may have fewer resources, but El-Sadr finds that people are much the same wherever she goes.

Indeed, the success of treatment has led to the once unthinkable: people with HIV wanting to start a family. In her clinic in Harlem, El-Sadr says that women even approach her about taking fertility pills. The risk of a mother transmitting HIV to her baby is significantly reduced with the right treatment, but she explains to her patients that there is no absolute protection. Still, she doesn't judge.

"We provide information," she says. "It's their choice."

What she cares about is offering help.

"Know your HIV status," she advises. "Don't wait until you're sick."

The Cutting Edge: The Future of Preventing HIV and STDs   By: Karen Barrow
There is currently only one product that can prevent HIV transmission during sex—condoms. But the race is on to create an alternative. And one of the biggest developments, microbicides, may be the favorite that will help reduce the spread of HIV and other sexually transmitted diseases (STDs) world-wide.

How Microbicides Would Work
Unlike condoms, which create a physical barrier to prevent the transfer of disease from one body to another, microbicides would form a chemical barrier inside a woman's vagina. This barrier could prevent both bacteria and viruses from spreading in various ways: by blocking the virus before it enters the body, preventing the virus from replicating, boosting the vagina's natural defenses or by directly killing the bacteria or virus before it infects the body.

No matter their mechanism of action, microbicides could be developed to target only HIV or a broad spectrum of STDs, both bacterial and viral, including herpes, Chlamydia, gonorrhea and syphilis. Additionally, microbicides may also include a spermicidal property to help prevent unwanted pregnancy.

They may be developed in the form of creams, gels, films or suppositories that are applied directly to the vagina. Just like condoms, early studies indicate that they will protect both sexual partners from disease transmission.

For American women, microbicides would offer an alternative to condoms and more protection than diaphragms, the pill or other forms of birth control, which do not offer any disease prevention. In fact, it seems that they will be just as effective when used in combination with these other types of birth control.

"We expect that a lot of women who are on the pill will use this as well to protect against disease transmission, said Ann Marie Corner, Senior Vice President of Cellegy, the manufacturer of Savvy, one of the microbicides in development, "But it seems that women will also be likely to use it with a condom, as it is also a lubricating gel."

Microbicides, however, will offer much more to women overseas.

The Spread of HIV
Even with numerous efforts to curb the spread of HIV, rates of the disease continue to grow, mostly notably in women around the world. The World Health Organization estimates that half of all people with HIV are women and third-world nations have been the hardest hit.

Women in these regions are often uneducated about sexual diseases and subjected to sexual violence. And while resources may be scarce, there are many programs that offer condoms to these women. But they don't always help, as the man has to be willing to wear it. Making matters worse, a woman is almost twice as likely to be infected by HIV after sex with an infected man than vice-versa.

"[Microbicides] are a way for a woman to control HIV and other disease transmission without a man's knowledge," said Dr. Christine Mauck, senior medical advisor at Conrad, a leading institution in testing various microbicides.

The Contenders
There are three microbicides currently in late-stage studies for FDA approval.

One gel, Savvy (C31G), created a buzz after being put on the FDA's fast-track system for approval in 2003. It works by preventing the infectious cell from entering the body. Early tests show that the gel is "highly potent" in fighting viruses and bacteria, and it is about 85 percent successful in preventing pregnancies with minimal side effects. Two other products, Carraguard and cellulose sulfate (also known as UsherCell), are also currently being tested for their effectiveness.

As of yet, all three microbicides have shown promise for use against HIV with minimal side effects. Only time will tell if these products prove to be just as effective in long-term tests and against other STDs. Still, while some experts may disagree, Mauck estimates that at least one of these products will be approved for use in three to four years.

Even though government approval may be far off, manufacturing companies have already established agreements with USAID, an American organization dedicated to helping underdeveloped nations, to provide microbicides to women in the most affected countries at an incredibly reduced cost.

"The hope is to give women something that doesn't need a partner's knowledge that will reduce rates of HIV to not only them, but their children as well," said Corner.

And while microbicides probably won't be provided at a reduced cost to American women, they would still be an inexpensive option to help make sex safer for everyone.

 Below, Perry Halkitis, PhD, a chair of the department of applied psychology at New York University, discusses the relationship between club drugs such as methamphetamine and HIV infection.

What is the state of the HIV epidemic today?
We've seen a worsening of the HIV epidemic in the last several years. Infection rates were stable during the 1990s, but in the last few years there's been a spike in new HIV transmissions across the population, especially among gay and bisexual men. In this population, there was a 14 percent increase in new HIV infections between 1999 and 2001.

What has lead to this increase?
First of all, there's a fatigue around HIV in the gay population and in the general population. People feel that the HIV epidemic is over, and they're more complacent about safer sex practices. They think there is a cure and, as a result, people are not being as safe or as responsible in their sexual behavior. Number two, prevention efforts haven't evolved as people have become sophisticated about HIV. So "use a condom every time" campaigns, which worked fine in the early 1980s and the mid-1980s, are no longer effective.

We're also seeing a complex interaction between sexual risk-taking and drug use in the gay population and also in the straight population. We're seeing this in particular with a subset of drugs known as "club drugs" because of their association with dance clubs and bars.

Are people still going to clubs to do these drugs?
Twenty years ago, these substances were used a lot in dance club situations. Our research shows very clearly that people do them at home, they do them with their friends, they do them in the park—they do them wherever they need to do them. Some people have suggested that maybe a better label for them would be "party drugs" because these are the drugs that people do to have wild and inhibited sex, to go dancing, or to do both of those things in combination.

Which drugs are contributing to increase HIV risk?
We're talking about methamphetamine, also known colloquially as "crystal." We're talking about MDMA, which is known commonly as "ecstasy." We're talking about ketamine, Rohypnol and we're still talking about cocaine, to some extent. Most importantly, we need to think about not just each of these drugs in isolation, but these drugs being used in combination with each other, and in combination with alcohol and prescription drugs such as Viagra.

Which drugs are the most worrisome and why?
Perhaps the most worrisome is methamphetamine. This is a psycho stimulant and a form of speed. Crystal is a hypersexual drug. It's a hugely disinhibiting drug. We know, and it's been clearly documented, that people who are using this substance have sex without rational thinking, they have multiple partners, they just let go. They feel like they're on top of the world, so nothing is a problem and any logical thinking around safer sex practices gets wiped away. Methamphetamine is also a problem because it's a highly addictive drug from a psychological perspective, so people have a very difficult time coming off of it because the cravings are so intense.
Does the way methamphetamine is administered affect HIV risk?
Absolutely. When a person first starts using it, methamphetamine is usually snorted. Eventually chronic users begin to smoke it because it is a more effective way of ingesting the drug; it gives a better and a longer and a faster high. Eventually, people who are dependent on the substance become injectors of methamphetamine. They inject it in their veins or muscles because it creates a much quicker and more intense high. So transmission through injection and the sharing of needles and the sharing of works creates another route of HIV transmission that is linked to methamphetamine use.

Do we know how much club drug use is affecting HIV risk?
We know—anecdotally in New York City and from documentation on the West Coast—that when we look at gay men who have become HIV-positive, more often than not, in the last several years, these men report having used methamphetamine with sex. So while we're not able to put an exact number on it, you can bet that a large percentage of new seroconversions are among people who are drug users.

Does methamphetamine make oral sex riskier?
We know that the mouth produces saliva, which has protective factors that assist in the prevention of HIV. When people are high on methamphetamine, they have extremely dry mouths. Suppose an HIV–negative person is using methamphetamine and is having sex with an HIV–positive person. That is more dangerous than having sex with a person who is not high on methamphetamine.

What role does depression play in drug use?
We should never deny the fact that drugs make people feel good; that's why they do them, right? What we know, also, is that people often use drugs in our society to mask bad feelings. So people who are experiencing depression or loneliness or low levels of self-esteem, which can be addressed with therapy and with medications, are self-medicating by using these substances. The unfortunate cycle that develops is that people, who are depressed, for example, go on crystal, use crystal, and feel better while they're high and then crash and feel even worse than when they started. When we address HIV in the United States, I think it's incredibly important that we think about the link that exists between drug abuse, mental health and HIV. Addressing one of those issues in isolation doesn't seem to be sophisticated any more. We need to address all those three things together.

How does drug use affect people on HIV therapy?
What we know, from our work, is that adherence—taking your medications the way you're supposed to take them—is a problem across the board. If we believe the literature, people are supposed to be adherent 95 percent of the time. It's very hard for people to be adherent 95 percent of the time when they're high. When they're feeling good, the last thing they want to do is actually stop to remember to take their medications. Number two, we know that methamphetamine is an immunosuppressant. Methamphetamine that is sold on the street is not pure methamphetamine. It's been cut with talc, heroin and variety of other substances that have an effect on people's immune systems. Number three, and probably most alarming of all, is that some recent studies indicate that even if an individual is highly adherent to his or her medications, if they are using methamphetamine, replication of the virus in the brain is accelerated.

What is your advice to people who use methamphetamine?
To people who haven't started and who hear wonderful tales about this drug, don't start using it. This is not a wonderful drug. The price that you will pay in the long run is not worth it. To people who have started, I say look for help. Because what do we know about methamphetamine and its effects on people's lives? People become physically ill and they become socially ill. They lose their friends, they lose their family and they lose their jobs. Methamphetamine has often been referred to as the "Grim Reaper" because of horrible and devastating effects it has on people's lives.

How can people reduce their risk of HIV?
Clearly, one of the strategies is abstinence from both sex and intravenous drug use. For young adults and for adolescents, becoming totally informed and educated about HIV and its transmission is going to be a very important strategy, as well as considering delaying the onset of sex until an individual is at a point where he or she can make the right choices around sex. The consistent use of condoms, of course, is important with anonymous or casual partners. Even in the context of some relationships that are not monogamous, the use of condoms is actually a really good idea. Finally, the mixing of sex and drugs is not a good idea. A glass of wine is very different from two lines of methamphetamine. The combination of drugs and sex is where a lot of the risk is happening now and where a lot of the transmissions are actually occurring.

It's extremely important for individuals in our country to remain informed. The disease is constantly changing. There are new medications that are coming out that are effective. But people are not necessarily living their whole lives with HIV; people are still dying. So remaining informed about HIV and remaining informed about strategies for safer sex is important.

Boosting HIV Detection With a Quick Test   By: Jeffrey Laurence, MD
Traditionally, getting tested for HIV has been a two-step process: arriving for the test, and returning a week or two later for the results. Approximately 8 to 10 thousand people tested in the United States each year do not make it to that second step. According to the Centers for Disease Control and Prevention (CDC), in the year 2000, those who did not return for results included 30 percent of the people who tested positive, and 39% who tested negative.

In November of 2003 the Food and Drug Administration (FDA) approved a test that provides results in just 20 minutes, and the availability of this test could have a profound effect on HIV awareness and prevention efforts worldwide.

Dr. Jeffrey Laurence is the Senior Scientific Consultant for Programs at the American Foundation for AIDS Research (amFAR), and Director of the Laboratory for AIDS Virus Research at Cornell University's Weill Medical College. In the following conversation, he describes how the test's quick results could boost awareness of HIV status, and, along with counseling, radically improve HIV prevention efforts.

First, what are the drawbacks of conventional testing?

The major problem is the time that it takes. It could take anywhere from one to two weeks to get the results. Also, you have a tube of blood drawn. Some people are upset about this if they haven't had it done before. It's also expensive. If you are tested in a hospital, versus a public clinic, the whole process could be anywhere from $50 to $100.

 What is the rapid test and how effective has it proven to be?
It's called the OraQuick test. It only requires a few drops of blood (taken with a finger prick), and it takes about 20 minutes to get results. The rapid test is supposed to be virtually identical in sensitivity and specificity to the standard test that may take over a week to get the test results back. And I suspect that the rapid test will cost about $20, which is a lot more affordable.

What are the implications of this rapid test?
There are several. I think the biggest benefit to public health and to patients is the speed of results. People get nervous, come in, get their blood drawn for the regular test, and never come back for the test results. With this rapid test, we'll be able to capture those people, because they will certainly sit there for 20 minutes and wait for the results. If it's a positive test, they'll need to come back for a confirmatory test, but as this is a very accurate test, presumably there will be very few false positives.

And those individuals who test positive, presumably, will be given appropriate post-test counseling, will not spread the virus to other individuals, and will perhaps make a decision to see a physician about drug treatment. So in that sense I think it's a very important test.

Are there downsides to the test?
The test is relatively easy, and we obviously don't want it to be abused. We don't want people to just decide that because the test is so rapid, we're not going to offer any counseling. We don't want, for example, some employer to decide to start testing employees or, people to start testing their lovers or friends.

I can't think of any downside with normal use of this test, but abuse could come in if there is failure to provide counseling or if the test is used illegally. There must be safeguards.

Do you think this test will become the conventional test for HIV?
I think this test could supersede the conventional test, yes.

How can people find a site that offers this test?
At this moment there are 40,000 sites, predominantly located within existing laboratory clinics and hospital clinics. You would need to call your local public health agency, the Board of Health, or go to your doctor, and they should know which doctors are associated with a hospital would have access to this test.

Who should be tested for HIV?
I think everyone should be tested for HIV. I think people going into a new relationship could be tested. Anyone that's had any potential risk factors for this disease should be tested. Clearly, our biggest emphasis should be on high-risk populations -- men who have sex with men, injection drug users, sexual partners of men who have sex with men, or sexual partners of injection drug users, people who have had multiple blood transfusions. People who have had other sexually transmitted diseases are at risk for getting HIV.

I would like to see this HIV test used routinely, and made part of a normal medical history. If there are any risk factors for HIV disease, the test can be offered, and because it's so quick, it could be offered right there and then.

There are lots of reasons why people don't want to be tested. But now we have effective treatments for the HIV virus. Many people are living long lives with HIV, and people should know that we have treatment options available if we tell them they're HIV positive.

Lipodystrophy: A New HIV Complication?   By: Donald P. Kotler, MD

In the early days of the HIV epidemic, there were no drugs available to fight the immune deficiency that resulted in AIDS-related opportunistic infections. Today, people diagnosed with HIV have a number of effective treatment options to choose from. But even though it is increasingly possible to manage the virus with medications, HIV continues to surprise those who have it and those who treat it. A recently recognized syndrome, called lipodystrophy, is being seen in more and more people with HIV. Characterized by fat loss or gain in particular areas of the body, it can dramatically change a person's appearance, which can lead to painful psychological challenges. But lipodystrophy can also raise the risk of heart attack, stroke or diabetes, compounding the challenges people with HIV already face.
Below, Dr. Donald Kotler, professor of medicine at St. Luke's Roosevelt Hospital Center, discusses what is currently known about the syndrome, and how it is being treated.

What is lipodystrophy?
Lipodystrophy has just been recognized in HIV-infected people over the past few years. It's a constellation of signs and symptoms that involve either fat loss or fat gain in various areas of the body. It's also associated with insulin resistance-which can lead to diabetes-as well as elevated levels of cholesterol and triglycerides in the bloodstream.

Could you describe a person who might be showing typical signs of lipodystrophy?
A typical patient is one who has been on highly active antiretroviral therapy for somewhere between 6 months to 2 or 2 ½ years. The person begins to notice that the legs are becoming very thin, the veins in the legs are very prominent, waist size increases and a large belly might develop, and there's a thickening of the soft tissue in the neck and upper body. Some patients will have thickening and enlargement of the fat pad in the back of the neck, so they look like they have a hump.

Other patients notice that their face changes shape. There is a flattening of the area to the sides of their nose and cheeks, and often there's thinning in the temple and the side of the head. There is often a dimple that is quite high, much higher than where the dimples usually are, and a very marked thinning of the facial skin.

Is lipodystrophy a dangerous condition?
Lipodystrophy can put some people at increased risk of accelerated atherosclerosis, or hardening of the arteries, or an increased risk of having heart attack and stroke, in the same way that high cholesterol and big bellies can put anyone at risk for these problems.

But another problem with lipodystrophy is the psychological difficulties it can introduce. People can feel stigmatized by the characteristic changes that occur in the face and body, and some patients may want to change antiretroviral therapy or stop it altogether as a result, which can significantly affect the patient's treatment.

In fact, lipodystrophy is one of the factors that are fueling a change in the way antiretroviral therapy is given now. Many of the current strategies-such as therapy interruptions-are attempts to decrease the amount of drug that people take. The impetus for that, in large part, is to avoid the metabolic changes that can lead to lipodystrophy.

How might HIV medications cause lipodystrophy?

The medication-induced changes in metabolism that lead to lipodystrophy are very complicated, and not well understood. Fat cells in the body are continuously being made and broken down. Some protease inhibitors appear to interfere with the development of new fat cells, which would lead to lipodystrophy. Protease inhibitors also may block proteases, enzymes in the body that are not related to HIV infection at all, but related to the handling of glucose-that is, how they produce insulin resistance-and how the liver handles fat. That may lead to rising levels of triglycerides in the bloodstream. Nucleoside reverse transcriptase inhibitors, another common medication for HIV, may affect certain cells components to cause lipodystrophy.

Also, patients with a family history of diabetes are much more likely to develop diabetes when they're on HAART therapy, or a combination of several antiretroviral agents.

 Are there any treatments for lipodystrophy?
There are two camps in terms of treating lipodystrophy. One camp believes that lipodystrophy is a medication problem and therefore the treatment should involve changing the medication-stopping it, decreasing it, or interrupting it intermittently.

The other camp believes that the symptoms of lipodystrophy are not necessarily related, and each of the abnormalities should be approached differently and treated differently. Diabetes could be treated with diabetic agents. Fat accumulation could be treated with diet and exercise, et cetera. If somebody has high cholesterol and a high risk of cardiovascular disease, what difference does it make if it's related to HIV or not to HIV? High cardiac risk is high cardiac risk, and it should be treated.

Now, that's a little bit simplistic, because if the high cardiac risk is due to a drug and you can change the drug and modify cardiac risk, that's important to know. But if you can look at somebody's risk factors and treat the risk factors, it really shouldn't matter whether it's an HIV syndrome or another syndrome. It's a risk, and it should be treated.

Also, it appears more likely now that fat accumulation and fat depletion are not always inextricably linked to HIV. Fat accumulation is a change that occurs naturally with aging, and certain people are genetically predisposed to have an excess of fat accumulation. It doesn't necessarily mean that it then is related to HIV or to medications. And I think that's where some of the confusion is going on

Despite these complexities, do you think that we are headed toward better treatment and more unified treatment goals among HIV doctors?

We can make some headway if we determine what it is we're trying to do, and most people are saying that we're trying to lower cardiovascular risk, make patients feel better about how they look, and above all, not lose control of the HIV, which is, after all, the primary goal of therapy.

As someone who's been in this field for a number of years, it's hard for me to say, "I don't really know what's going on, or how this is happening, but here is what we should do about it." On the other hand, people in medicine know a great deal about treating cardiovascular risk, and treating cholesterol, diabetes, et cetera. My own personal view is that we should take the abnormalities one by one and treat them. One thing we do know is that none of these abnormalities are irreversible. Even the lipoatrophy that seems so severe has been shown to improve. And I believe that over the next several years there will be new knowledge and better therapies to treat the effects of lipodystrophy. I think it is not appropriate to just give up.

Introduction to HIV    By: Brian A. Boyle, MD

What are HIV and AIDS?
How AIDS Works in the Body
HIV Treatment
Who Should be Tested for HIV?
HIV Contraction
Common Misconceptions About Contraction
The Importance of Testing and Diagnosis
How Does HIV Testing Work?
Test Counseling
What are HIV and AIDS?
The Human Immunodeficiency Virus, which is commonly called HIV, is a virus that directly attacks certain human organs, such as the brain, heart, and kidneys, as well as the human immune system. The immune system is made up of special cells, which are involved in protecting the body from infections and some cancers. The primary cells attacked by HIV are the CD4+ lymphocytes, which help direct immune function in the body. Since CD4+ cells are required for proper immune system function, when enough CD4+ lymphocytes have been destroyed by HIV, the immune system barely works. Many of the problems experienced by people infected with HIV result from a failure of the immune system to protect them from certain opportunistic infections (OIs) and cancers.

Defining the terms
People infected with HIV are broadly classified into those with HIV disease and those with Acquired Immunodeficiency Syndrome, or AIDS. A person with HIV disease has HIV but does not yet have any symptoms or related problems, and still has a relatively intact immune system (that is, a CD4+ lymphocyte count greater than 200 cells/mm3). A person with AIDS, on the other hand, has very advanced HIV disease and his or her immune system has incurred significant damage. As a result, people with AIDS are at very high risk for a number of OIs, cancers, and other AIDS-related complications. The Centers for Disease Control have defined the conditions that mark a progression from HIV disease to AIDS. They are: certain infections, such as repetitive pneumonias, Pneumocystis carinii pneumonia (PCP), and cryptococcal meningitis certain cancers, such as cervical cancer, Kaposi’s sarcoma, and central nervous system lymphoma CD4+ count less than 200 cells/mm3 or 14 percent of lymphocytes
How AIDS Works in the Body
Before highly active antiretroviral therapy (HAART) became available, most people who contracted HIV eventually progressed to AIDS and had some AIDS-related complication, such as:
a deterioration of immune system function and an increased risk of infections and cancers
brain damage that may cause dementia or memory loss
heart problems that can cause heart failure and symptoms such as shortness of breath, fatigue, and swelling of the abdomen and legs
severe kidney damage requiring dialysis
an inability to perform activities of daily living such as balancing a checkbook or driving a car
metabolic changes that may cause significant weight loss or diarrhea

Due to these potential problems, a person with AIDS is at very high risk of becoming very ill, and, if some action is not taken to protect the person from these infections or reverse the damage done by HIV, he or she is at risk of dying.

The speed of progression to AIDS
The damage caused by HIV occurs more quickly in some people than in others, but generally an untreated HIV-infected person can expect that they will progress to AIDS within 10 years of their infection. During the time the person is infected with HIV, a war rages between the person’s immune system and HIV, with HIV slowly wearing the immune system out.

A slow progress: A number of factors can affect how rapidly HIV progresses, some that can be controlled, and some that can’t. Some people have certain genes that slow HIV progression, or they are infected with a weak strain of HIV that their immune system is more able to control. In general, taking better care of yourself and following your doctor’s advice also slows the progression of HIV disease to AIDS.

A more rapid progress: Factors that may cause a more rapid progression to AIDS are: infection by a virulent strain of HIV, having a high viral load setpoint (a certain level of HIV replication that varies from person to person), older age, and the abuse of drugs or alcohol.
HIV Treatment
In the time between initial infection and AIDS, the infected person may feel relatively normal, despite the constant attack by HIV. People living with HIV have to understand, however, that despite feeling well on the outside, significant damage can be occurring on the inside. Fortunately, over the past five years, significant progress has been made regarding the treatment of HIV and prevention of some of the infections and cancers that may be caused by it. Antiretroviral medications can directly attack HIV and stop it from reproducing and causing further damage. For most people, the biggest factor in preventing progression to AIDS is adherence to HAART, which can suppress HIV replication to very low levels and not allow it to continue to attack the body.

Prophylactic Medications
In addition to HAART, other steps can be taken to prevent illness in people living with HIV and AIDS. Certain antibiotics, called prophylactic medications, can effectively prevent opportunistic infections. A physician can help to assess the appropriateness of these medications in a particular treatment program, and which ones to use, but it is important that they be taken as prescribed so that infections can be prevented. With careful monitoring, OIs and certain cancers can be detected in their early stages before they have spread, and the antibiotics can work more effectively to ward off further serious complications. I recommend that every person living with HIV or AIDS see a physician for appropriate monitoring and treatment.
Who Should be Tested for HIV?
In the early 1980s, when HIV infections were first starting to appear, HIV was associated primarily with gay men. Then it became associated with intravenous drug users and hemophiliacs. During the past 20 years, however, HIV has become a disease that can affect almost anyone who is not monogamous with an uninfected person.

HIV Contraction
HIV is contracted through an exchange of bodily fluids, such as blood, semen, or vaginal secretions. As a result, the most common ways of acquiring HIV are sharing needles while doing intravenous drugs, and sex, especially anal intercourse. While the highest risk of HIV transmission is associated with anal intercourse, vaginal intercourse is becoming a common means of spreading HIV. Vaginal intercourse is the most rapidly growing risk factor for acquiring HIV infection in the United States and in the developing world it is the most common method of HIV transmission. Everyone must take appropriate steps to prevent the spread of HIV: Safer sex with condoms and dental dams and not sharing needles can help prevent the spread of HIV.

Common Misconceptions About Contraction

People are often concerned that HIV can be contracted through common contacts with an HIV-infected person, such as shaking hands or sharing glasses or eating utensils. These are not risk factors for contracting HIV. There is no evidence that HIV can be spread through these means, and people should not be afraid to be around people who have HIV or to use a glass, eating utensils, or plate that an HIV-infected person has used, or to have other common contacts.

Those who should consider being tested for HIV include:
people who received a blood transfusion or blood product at any time, but especially in the late 1970s or 1980s
homosexuals and heterosexuals who have a history of unprotected sex with potentially infected persons
people who have had multiple sex partners
people who have had a sexually transmitted disease such as syphilis or gonorrhea
people who are intravenous drug users
pregnant women

The Importance Of Testing & Diagnosis

The importance of testing and diagnosis has increased over the past five years. Before the improvements in antiretroviral therapies, many people believed that there was little that could be done to prevent the progression of HIV and so they did not get tested. While these people were right about the ineffectiveness of the antiretroviral therapy available at that time, they failed to recognize that medicines had been discovered that could prevent many of the common infections that afflict AIDS patients. Thus, many people were diagnosed with HIV only after they were admitted to the hospital with severe infections, especially PCP. Some died needlessly because they had not sought appropriate medical care and did not receive one of the medications that could have prevented PCP from occurring.

Now, there are even more reasons to seek HIV testing and medical care. Within the past five years, the medicines to prevent infections have been significantly improved and effective antiretroviral therapies have been developed that can not only halt the progression of HIV, but can also reverse much of the damage that has already been done. Therefore, it is important that HIV is diagnosed while the person is relatively healthy and before a major, potentially life-threatening OI occurs, such as PCP or cerebral toxoplasmosis. With HIV, what you don’t know can hurt you.

If you think you are at even slight risk of having HIV—if you have had numerous sex partners or if you have had sex with someone who might have been bisexual or had a history of intravenous drug use—you should be tested. If you test positive, you can then receive medical care necessary to keep you healthy and prevent the diseases that occur in untreated AIDS patients. If, on the other hand, you wait until you feel sick before you are tested, you may already have progressed to AIDS and your immune system may already have incurred significant damage that may not be reversible.

Pregnant Women

Recent advances in therapy have also led to effective methods of preventing mother-to-child transmission of HIV. Virtually every pregnant woman, especially those who have a history of intravenous drug use, have had sex with someone in a high-risk group, or who have had numerous sexual partners, should be tested for HIV. HIV-infected mothers should consider taking antiretroviral, which can effectively prevent transmission to the infant. Since breast-feeding can also cause transmission of HIV to the infant, HIV-infected mothers should not breast-feed their infants if there is an available alternative. Many states also require testing of the infant at birth, so that appropriate treatment can be provided.

Testing Is Voluntary & Confidential

Under most circumstances, HIV testing is voluntary. Unless there are special circumstances, most states require a person to give specific permission, called informed consent, before he or she can be tested for HIV. Privacy and confidentiality are legitimate concerns for people who are being tested for HIV. Most people do not want other people or organizations, such as their employer, to know they are HIV-infected and most don’t even want them to know that they are being tested. Most states have laws that protect the confidentiality of HIV testing and the diagnosis of infection. While accidental disclosure of a person being HIV positive can occur, in my experience it is extremely rare. It’s a mistake to avoid testing because of fear of accidental disclosure.

Also, there are other options including anonymous testing in a clinic or at home (for example, Home AccessR), where you are identified by a number, not by name, and no one but you know your number. The cost of testing is generally between $30 and $100, and some groups, including many health departments, provide testing free of charge.
How Does HIV Testing Work?
HIV is usually diagnosed by a blood test, but newer tests can be done on saliva or urine. If you’re squeamish about getting blood drawn, there are alternatives you can discuss with your doctor. Generally, the purpose of the test is to search for antibodies to the virus. The initial test is an enzyme-linked immunoabsorbent assay (ELISA) and is confirmed using a test called the Western Blot. The antibody tests are very reliable, but may not be able to detect an infection during the first six months after an exposure. There is also a test that can test for the presence of the virus itself, and this test is called an HIV PCR. HIV PCR is used to test for HIV after a potential HIV exposure, but before antibodies have developed. Because infants may have their mother’s antibodies in their blood confounding the HIV antibody test, HIV PCR is also useful for them. However, HIV PCR may not be reliable in detecting HIV in all infected patients, especially those with a low viral load.

How Long Do The Results Take?
It used to take several days to a week to get test results back. Now there are rapid detection methods that allow reliable results in less than an hour. As a result, HIV testing can be completed while you are still in your doctor’s office.

Test Counseling
Pre-test and post-test counseling and education are important parts of HIV testing. Counseling gives people who test negative for HIV an opportunity to learn more about HIV and how to avoid becoming infected. For those who test positive, counseling gives them a chance to learn about the importance of being medically evaluated and, if appropriate, treated so as to prevent disease progression or OIs. These counseling sessions take about 15 minutes, including time for questions. They are a very valuable part of the testing process, regardless of the test results.
HIV disease is a chronic disease that used to be fatal for virtually everyone who got it. Now, things have changed and effective treatments are available to treat HIV and, in most cases, these treatments can prevent HIV from doing further damage and can keep the person healthy. In order to take advantage of these treatments, you must be tested and diagnosed with HIV. All persons who may have been infected with HIV and virtually all pregnant women should be tested as soon as possible.

Nutrition and HIV Infection   By: Meredith Liss, MA, RD, CDN
Good nutrition is a co-therapy that can help maximize your medical treatment of HIV. In the early days of the epidemic, when people with HIV were losing large amounts of weight, it was recommended that they pile on the calories, without paying attention to the quality of the foods chosen. Excess fats and sugar were encouraged with hopes of any possible weight gain.

Today’s Diet For Those Wth HIV

The modern day diet recommendations for those with HIV include a high protein diet to help fight the wasting syndrome, a heart healthy, low saturated fat diet to keep cholesterol levels within acceptable limits, a diet high in whole grains, and low in sugar to maintain adequate blood sugar and triglyceride levels. In my practice, I promote a diet that contains whole grains, lean sources of protein, low fat dairy, plenty of fruits and vegetables, and healthy fats. I also recommend 1-2 multi-vitamins with minerals each day to insure that micronutrient needs are met.

The Food Guide Pyramid was established by the United States Department of Agriculture (USDA) and is used as a tool to teach people how to eat a balanced diet. The pyramid recommends a certain number of servings of grains, fruits, vegetables, meats, and dairy per day. Whether you have wasting syndrome, fat redistribution syndrome, high cholesterol levels, high triglyceride levels, or high blood sugar levels, I recommend a diet that reflects the food guide pyramid, with a few modifications. Below is a list of different food groups, the recommended number of daily servings of each group, and examples of the amount of food that constitutes a serving. In addition there are tips for making good food choices within each group.

Bread, cereal, rice, and pasta (6-11 servings per day)

1 slice of bread
½ bagel or ½ English muffin
½ cup of cooked pasta, rice, or hot cereal
1 ounce of ready-to-eat cereal
* Choose whole wheat bread, bagels, and English muffins, brown rice, and high fiber cereals (cereals with at least 3 grams of fiber per serving).
Vegetables (at least 3 servings per day)

½ cup of chopped raw or cooked vegetables
1 cup of leafy raw vegetables
* Choose dark green leafy vegetables rather than iceberg lettuce.
* Choose a variety of vegetables with a variety of colors.
Fruits (at least 2 servings per day)

1 piece of fruit or melon
¾ cup of juice
½ cup of canned fruit
¼ cup of dried fruit
•    Choose fresh fruits more often than juices.

Milk, yogurt, and cheese (at least 2 servings per day)
1 cup of milk, soy milk or yogurt
1 ½ to 2 ounces of cheese
* Choose skim or 1% milk, low fat yogurt, and low fat cheese. Soy milk does not have to be low fat, because it contains healthy fat.
Meat, poultry, fish, beans, eggs, and nuts (at least 3 servings per day)

2-3 ounces of cooked lean meat, poultry or fish
The following foods are equivalent to ONE ounce of meat (1/2 to 1/3 of a 2-3 ounce serving):
1 egg or ¼ cup of fat free, cholesterol free egg alternative
1/3 cup of nuts
2 tablespoons of peanut butter
½ cup of beans
* To prevent or reverse muscle wasting, try to include a source of protein with each meal or snack.
* Choose skinless poultry and fish more often than red meat.

The Food Guide Pyramid recommends that you use fats and oils sparingly, but does not differentiate between the different types of fats. To reduce cholesterol levels and minimize your risk for heart disease, I recommend that you decrease your intake of foods high in saturated fat, which include red meat, poultry skin, whole and 2% milk, cheese, butter, ice cream, coconut and palm oils. In their place, I recommend foods that are high in monounsaturated fat such as olive oil, canola oil, avocados, olives, nuts, and nut butters. You should also increase your intake of foods rich in omega 3 fatty acids, such as fatty fish (salmon, mackerel, herring), walnuts and flaxseeds.
Maximizing Your Nutritional Intake
One of the causes of weight loss in HIV infection is not being able to eat enough calories. At different times you may not be able to eat as much as you normally do. You may find that you get hungry and excited about a meal, and then, when you sit down to eat; you become too full too fast. If you encounter this problem, you should talk to your doctor about it since there are some medical causes for early fullness. Also, my advice to my clients is to adopt a pattern of small, frequent meals. You can eat six or more small meals each day. All the calories consumed from eating small, frequent meals throughout the day may even equal the same amount of calories you would have consumed from three large meals. Examples of healthy, small, meals are:
bowl of cereal
½ sandwich
hard boiled egg
granola bar
4 oz yogurt
fresh fruit
½ cup of canned fruit
peanut butter on crackers
dried fruits and nuts
leftovers from last night’s dinner

If liquids are easier to consume than solids, you should concentrate on high calorie, high protein beverages. Shakes can be made at home in a blender using ingredients such as ice cream, yogurt, sherbet, milk, fruits, peanut butter, wheat germ, and fruit nectars. You can mix and match ingredients, and use your creativity to concoct a delicious shake. You also can take advantage of the canned supplements that can be purchased at your local supermarkets or drug stores.

If these ideas are not successful in increasing your nutritional intake, you can ask your doctor about medications to help stimulate your appetite.
It is beneficial for HIV positive individuals to incorporate exercise into their health maintenance programs. Exercise is safe and does not weaken the immune system. It is important to prevent or fight the loss of muscle mass and to offset the effects of the fat redistribution syndrome. The benefits of exercise include increased muscle mass, increased strength, increased energy, improved appearance and self-esteem, and improved appetite. According to the American College of Sports Medicine, regular physical activity reduces the risk of heart disease, an important goal for people on HAART therapy. However, before heading to the gym, I recommend obtaining medical clearance from your doctor.

Resistance Exercise

Resistance exercise includes activities such as weight lifting, sit-ups, and push-ups. Resistance exercise is recommended to maintain adequate muscle mass, or to bulk up thinned arms and legs seen in the fat redistribution syndrome.
Aerobic Exercise
Aerobic exercise includes activities that make your heart beat faster such as jogging, biking, dancing, basketball, or even walking at a fast pace. If you are concerned about fat accumulation in your stomach region, aerobic exercise may be beneficial in burning off some of that fat.

Hormonal Treatment Of Muscle Wasting
Research has shown that between 6% and 50% of men with AIDS are hypogonadal (low levels of testosterone) and that testosterone levels correlate with muscle mass. In other words, if your testosterone level is low, your muscle mass may also be low and vice versa. It is therefore a good idea to talk to your doctor if you are losing weight, especially if you also are experiencing easy fatigability or a loss of sexual desire. If you are found to have a low testosterone level, you can receive replacement doses that may help maintain adequate muscle mass. Testosterone levels have also been shown to be low in women. Replacement in women is controversial because of the potential masculinizing effects of testosterone. You can discuss the potential risks and benefits with your doctor. Other anabolic therapies are used to treat muscle wasting in both HIV positive men and women and may have less masculinizing effects. Discuss these options with your doctor.
Bottom Line
Why not be the best you can be? Eat a well balanced diet, exercise regularly, take a multi-vitamin with minerals daily, and be aware of the potential nutrition-related problems (muscle wasting, poor appetite, malabsorption, fat redistribution syndrome, high cholesterol levels, high triglyceride levels, high blood sugar levels, and low testosterone levels) so that you can try to prevent them or treat them in their beginning stages, when they are most easily corrected.

Complementary/Alternative Medicine Approaches to HIV Disease.
The two major ways in which I find complementary/alternative medicine (CAM) strategies helpful with my HIV-positive patients are in the enhancement of immune function and in the treatment of HIV-related symptoms and of medication-related side effects.

CAM for Immune Support
There is a huge amount of interest—not just from people with HIV, but from people with cancer and other life-threatening illnesses, as well as from people who simply feel they get sick more often than they should—in the use of CAM strategies to boost the immune system. There is some reasonable evidence for the use of some of these strategies, and almost no evidence for the use of others. Let's look at a few of the most popular ones in turn.

Echinacea has been proven to work well in decreasing the severity and duration of acute upper respiratory illness (the common cold or URI). Many people use it for prevention of viral illness, but the studies on this have not proven that it works. This herb definitely has immune-stimulating properties, increasing levels of some of the chemical signals that activate T cells and stimulating production of antibodies. There has been some concern about whether this T-cell stimulating effect could be dangerous in HIV positive people, as it might cause a rise in viral load as a result of increasing replication of infected T cells. In fact, some texts recommend that HIV-positive patients avoid the use of Echinacea. Many clinicians, though, myself included, feel that short-term use of Echinacea for treatment of URI is very unlikely to be dangerous. If you are having a viral-load measurement done, though, and you have been recently taking Echinacea, you should make sure your practitioner knows about the possible effect on viral load so that a rise is not interpreted as a failure of your antiretroviral. If you have been on Echinacea and there is a rise in your viral load, stop the herb and repeat in two weeks to determine if this rise is a real medication failure. Because long-term usage of Echinacea has not proven to be beneficial in any studies, and because there may be some level of risk involved, I do discourage maintenance use of Echinacea for my patients.

Astragalus is a Chinese herb used in many tonic formulas in Chinese medicine. This herb is also extremely popular among HIV patients. Like Echinacea, it does have proven immune-stimulating properties. As with all of the herbal remedies I will mention in this article, there is no definitive evidence that it can alter the course of HIV disease. Many patients choose to take one of the Chinese formulae containing Astragalus as part of their immune system “health maintenance.” Other common constituents in these formulas, which also demonstrate immune-stimulant effects in the laboratory, are licorice and maitake, reishi, and shiitake mushrooms. There is no evidence of significant harm with any of these formulas, nor has there been proof of any significant benefit. Licorice can raise blood pressure, so your blood pressure should be monitored during the course of treatment with this herb. Some other non-Chinese herbs, also in this same category of potential but unproven benefit, include cat's claw and pau d'Arco, two South American herbal medicines.

High-dose Vitamin C
is a less popular alternative since the onset of the new generation of medications, but still quite widely used. Vitamin C at high doses has an anti-HIV effect in the test tube, as well as anti-oxidant properties. Many patients choose to use intravenous (IV) vitamin C in hopes of achieving the super-high levels of vitamin C in the bloodstream required for this anti-HIV effect. Doses can range from 20 to 60 grams at a treatment. Typically, people cannot take more than 10 to 20 grams orally per day without developing diarrhea—so they use the IV approach, which doesn't cause diarrhea. The anti-oxidant approach to HIV therapy stems from the finding that much of the tissue damage done in the body during the progression of HIV disease is a result of the generation of a type of chemicals in the body called free radicals, which can be very destructive to many organ systems. The anti-oxidant substances, which include vitamin C, vitamin E, beta-carotene, selenium, alpha-lipoic acid, grape seed extract, coenzyme Q10, pycnogenol, n-acetyl cysteine (N-AC), and many others, have formed a central part of the “immune support” strategies for many people with HIV. As with the immune stimulant herbs, although there is a reasonable theoretical justification for this approach, no one has yet been proven a definite benefit. Fortunately, most of these substances are quite safe, so other than the cost, there is probably nothing to be lost by including them in the overall treatment plan. IV vitamin C should be given with caution, particularly in people with a family or personal history of kidney stones or any other significant kidney disease.

Mind-body strategies has the strongest evidence of all the CAM approaches to support its use as a safe long-term strategy for boosting immune function. Test-tube, animal, and human studies have all definitively proven the impact of poorly-controlled stress on immune function. There is no conclusive large trial yet proving its benefit in HIV, but a program of 10 to 15 minutes twice daily of either meditation, visualization, yoga, or other “centering” physical exercise (or other relaxation strategy) should absolutely be a part of everyone's overall immune support program. Likewise, nutrition and aerobic exercise are critical to healthy immune function, and need individually tailored approaches for everyone.

Spermicides and Condoms: Not the Best Marriage?   By Peggy Crane

It is a well-known fact that consistent and correct use of condoms can prevent pregnancy. But condoms are not perfect. They've been known to break on occasion, and people don't always use them correctly. That's why doctors have recommended that they be used in conjunction with an over-the-counter spermicide for extra birth-control insurance.

But say the word "condom" and what comes to mind more often is its reputation as the method of choice for practicing safe sex. Condoms are now primarily used to prevent many sexually transmitted diseases, including HIV, the virus that causes AIDS.

In the late 1980s, nonoxynol-9, a product that has been on the market for more than 50 years and is the main ingredient in most spermicides, began to show promise as a method for preventing HIV transmission when it was observed to kill the virus in a test tube. The public and the medical community alike hailed N-9 as the newest HIV preventative, and many condom manufacturers hastened to lubricate their products with the chemical.

Unfortunately, hopes were dashed when more recent studies — including a four-year World Health Organization study of HIV-negative female sex workers in Africa and Thailand — showed N-9 to be ineffective in the prevention of HIV infection. In fact, researchers discovered that when used frequently, products containing N-9 may even increase the risk of acquiring the virus.

Understanding what N-9 can and cannot do can be daunting, much less making the right choices regarding its use. Below, Rowena Johnston, Ph.D., Associate Director of Basic Research at the American Foundation for AIDS Research (amfAR), shares the latest findings about N-9 and stresses correct condom use as still the best defense against HIV transmission for men and women alike.

Are condoms a foolproof method of HIV prevention?
If everybody used them all the time, condoms would do a good job of slowing down transmission. The problem is that people don't use condoms all the time. People often feel uncomfortable insisting on the use of a condom with their partner. We really need products that don't require a partner's consent. That way, we'd feel free to protect ourselves and take charge of our own health.

Many people think they are at low risk for HIV, so why take the trouble to use a condom?
Some women may think of themselves as fairly low-risk and therefore might not insist on the use of condoms. But that's a serious mistake. There are straight men out there, too, who don't think they need to protect themselves from infection because they still think HIV is a "gay" disease.

Why don't people use condoms more consistently when this simple device is obviously the key to safe sex?
I think what we're seeing now is kind of a fatigue. People have been aware that they should be practicing safe sex since the 1980s. Our sense is that people are kind of getting sick of being good all the time. You know, it's as if you're on a diet and sometimes you want to eat chocolate.

But that's precisely why you should stick with the diet.

How does Nonoxynol-9 work against HIV?
HIV is a virus that has a fatty membrane around it, just like our own cells have. Nonoxynol-9 is essentially a detergent. Detergents cut through grease, and that's exactly how N-9 kills HIV and other sexually transmitted infections. But it only does the job in a test tube. What we found in this study was that once you put N-9 in a woman's vagina, it will also cut through the fat of her cells, which makes it easier for HIV to get into those cells. Women who are highly exposed to N-9 actually show ulceration on the tissues of the vagina, and those ulcers can enhance the ability of HIV to get in. The same holds true for men. The rectum is even more vulnerable than the vagina to the effects of N-9.

Many experts still recommend N-9 as a contraceptive for women at low risk for contracting HIV. Do you agree with that?
I think if a woman is not using N-9 very often, there probably is a low risk of ulceration. It's not a perfect birth control method anyway, of course. But I really think that people should be using condoms all the time to make sure that they're safe.

There are a lot of condoms produced today that contain N-9. In light of recent findings, is this likely to change?
There has been a move to urge condom makers to take N-9 out of their condoms. Studies have shown that if you're using a condom correctly, the additional protection you get from N-9 in terms of preventing pregnancy is negligible, plus you're running the risk of increasing the transmission of HIV. We feel that adding N-9 isn't worth it, given the risks involved.

What is the state of HIV infection in the United States today?
We estimate that there are about a million people infected in the United States, of which only about two thirds know that they're infected. The number of new infections each year has remained quite stable for the last four or five years, at about 40,000 new infections each year. The thing is, the proportion of those who are women is rising precipitously. And the proportion of those who are African American is also rising, so a disproportionate share of the new infections are occurring in women, African Americans and Latinos.

Do we know why?

That's a really tricky question. Our prevention messages may not be working equally well in every community. Obviously, we need renewed efforts, new ways of tackling the problem, and new ways of communicating with diverse ethnic and age groups.

Do you think that the failure of N-9 to produce positive results will dampen hopes for a product that really works against HIV?

I hope not. After all, we had a promising product, we tested it, and we learned that nonoxynol-9 doesn't work. We also learned why, which means that we learned what we shouldn't be trying in the future. Now we have a better idea of what we should be looking at. Researchers are looking at different classes of chemicals that could disable HIV in completely different ways while leaving the vaginal and rectal lining intact. 

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