Welcome to our new staff member RamÛn Caba. He joins our other New York City Case Management program staff Ken Fornataro, Maximo Sepulveda, Lydia Kelly and Chris Scott. New Yorkers in need of assistance paying for treatments or health care services are encouraged to check out our case management program. Since the program opened, we've helped dozens of people to deal with housing issues, insurance and entitlement problems, and managing their HIV treatment regimens. English or Spanish speaking clients in the program also receive supportive counseling services when needed. So if you need information about treatments for AIDS and HIV-related conditions, help getting medical care or support services, or someone to help you manage your HIV treatment strategy, contact us at (800) 734-7104. There is no fee for any of the agency's services or resources, nor is any type of insurance or entitlement program required. Any New York City resident with HIV is eligible for the program.

Depending on the side effects you're experiencing and your current health, it may be possible to treat or manage them:

• with nutritional supplements, dietary changes, or medications (see article)

• by switching the drug combination that you are taking (see article)

• or by participating in a structured drug interruption, sometimes referred to as a "drug holiday." Several new research studies (clinical trials) are investigating these options. These studies are described in detail in The Experimental Treatment Guide, a free directory available from The Network.

Most of the available anti-HIV drugs were approved based on short-term studies. Now that new drug combinations - called HAART - have been around for a while, side effects are showing up that weren't reported in the original studies. The most common and potentially most serious side effect is being called lipodystrophy.

The signs of lipodystrophy are a swollen belly along with loss of tissue from the face, arms and legs. The loss of fat from the face can give an appearance of sunken eyes and sticking-out cheekbones. The combination of extra fat around the belly and loss of tissue from the arms and legs can look similar to the effects of very poor nutrition. Lipodystrophy also looks a bit like wasting, which used to be a common problem in people with AIDS. It's very important to know that lipodystrophy and wasting are NOT THE SAME. While lipodystrophy has been linked by some to HIV, it is mainly associated with the use of HAART. Wasting is not linked to HAART, but can be seen with HIV, cancers, other infections, and malnutrition.

In addition to these changes in fat and tissue that can be seen, there are a number of other problems that researchers have linked to lipodystrophy:

• High levels of fats (known as cholesterol and triglycerides) in the blood.

• Insulin resistance, elevated blood sugar (glucose) and, in some cases, diabetes.

• Sometimes fat accumulates on the back of the neck. This is sometimes referred to as buffalo humps (diffuse fat accumulation). Fat can also accumulate in other parts of the body as lipomas. A lipoma is a benign (usually harmless) tumor, surrounded by a distinct membrane. Whole lipomas can usually be easily removed, depending on their location.

The exact reasons why HAART causes lipodystrophy are still not clear. The name lipodystrophy is being used to describe a bunch of different problems and side effects, which may not all have the same cause. So far, studies have shown the following:

• High levels of cholesterol are seen more with protease inhibitors (Crixivan, Fortovase, Norvir, Viracept) than other anti-HIV drugs. There is some evidence that the most recently approved protease inhibitor, Agenerase, will have less effect on cholesterol and triglycerides than other protease inhibitors. More studies of Agenerase are needed to prove this, however. The NNRTI anti-HIV drug Sustiva has also been shown to increase cholesterol levels.

• High levels of triglycerides are also seen more with protease inhibitors than with other anti-HIV drugs. However, the NRTI drug ddI (Videx) - and possibly other NRTIs - can sometimes increase triglycerides. HIV infection itself has also been linked to higher than normal triglycerides.

• Similar to triglycerides, high blood sugar and insulin resistance have most commonly been seen in people using protease inhibitors, but Videx can also cause the same problem.

• Changes in body shape (including buffalo humps), facial wasting and loss of muscle tissue have also been reported mainly with protease inhibitors, but several studies have seen similar problems in people taking only NRTIs.

• Loss of muscle tissue is a well known side effect of long term use of AZT (Retrovir).

This suggests that what's being called lipodystrophy may be a combination of long-term side effects from the different drugs used in HAART. Before HAART combinations became common, people may not have taken NRTI drugs as regularly as they do now. Some of the problems seen with lipodystrophy may be long term side effects of NRTIs that hadn't shown up before.

One leading GI doctor, Don Kotler, thinks the fast drop in HIV levels after starting HAART may also have something to do with lipodystrophy. His idea is that the body is stressed by fighting HIV and that the sudden reduction in HIV levels may cause a kind of stress hangover, leading to changes in normal metabolism.

Confusingly, there's no reason why ALL these factors mightn't be part of the problem. Although lipodystrophy is being used as a general name, that doesn't mean that these different side effects always happen together. Several studies have found that some people get changes in body shape, without big changes in blood fat levels. The opposite - high blood fat levels without changes in body shape - has also been reported. The same kind of disconnect has also been seen with other lipodystrophy-associated problems like buffalo humps and high blood sugar - they can sometimes happen without other problems occurring.

All of this complication and confusion doesn't sound very encouraging, but it gets back to the idea of treating each person as an individual. If you're experiencing any of these HAART side effects, it's important that you and your doctor look at all the possible lipodystrophy-associated problems and work out which ones you're actually dealing with.

HAART and Your Heart
The most serious of the lipodystrophy-associated side effects seems to be heart problems caused by high fat levels in the blood. There have been reports of people on HAART experiencing potentially fatal heart attacks. For anyone on HAART, it's very important to make sure you're being monitored for any risk of heart disease.

A more technical review of recent lipodystrophy information is available at: http://HIV.medscape.com/ Medscape/HIV/journal/1999/v05.n03/mha0602.kotl/mha0602.kotl-01.html. The report is from the Third International Conference on Nutrition in HIV Infection that was held in Cannes, France - April 22-25, 1999. The report is written by Donald P. Kotler, MD, and Ellen S. Engelson, PhD.

Nutritionist Donna Tinnerello provides some tips for trying to reduce the symptoms associated with lipodystrophy using nutritional supplements and dietary changes. The content provided in this article is meant for information purposes only. It may or may not apply in your particular situation. Elevated cholesterol and triglyceride levels have been reported as a side effect of protease inhibitors. The dietary modifications suggested in this article are backed by research and have been demonstrated over time to work in the general population. Always discuss any nutrition issues you have with your provider.

Supplements can be expensive, but some vitamins, minerals and nutritional supplements are covered by ADAP (the AIDS Drug Assistance Program) and Medicaid. Call the Network if you need to find out which supplements are available through these programs.

See the article, "Switching Drugs" for more information about switching drugs to manage or reduce the symptoms of lipodystrophy.

For people with low T-cells and few remaining HIV treatment options, switching treatments to manage or reduce the symptoms of lipodystrophy may not always be possible. Some doctors are trying to treat lipodystrophy-associated side effects using the fat-lowering drugs Lopid and Lipitor. These drugs have shown some success in reducing cholesterol and triglyceride levels. Diabetic drugs may help with high blood sugar. A drug called Serostim (human growth hormone) has been shown to improve body shape changes a little, but the effect seems temporary. Also, Serostim had no effect on cholesterol levels.

The Network asked Donna Tinnerello, RD, MS, HIV Nutritionist at Cabrini Medical Center in New York City, for nutrition and supplement tips that may help delay or reduce symptoms associated with lipodystrophy.

Carbohydrate/Sugar intake

DT: You need carbohydrates, not refined and not simple sugars (carbohydrates are substances in food that can get converted into energy in the body). I tell every one to eat high fiber foods like oatmeal for breakfast - studies show that one cup a day of oatmeal lowers cholesterol nicely. Oatmeal contains soluble fiber that's also found in beans, barley, potatoes, fruits and vegetables. Things like whole wheat, brown rice and other whole grains have mostly insoluble fiber. They are broken down to sugar very slowly therefore they don't raise blood sugars. If blood sugars are normal and dietary fats are kept to a minimum, triglyceride levels should not be higher than normal.

Simple sugars like table sugar, regular sodas, fatty desserts, even fruit juices that quickly get broken down to simple sugar should be avoided. People with AIDS should try to eat well cleaned fresh fruit instead of juice. Simple sugars go to the liver, and the liver makes fat out of the sugar - that's one way the triglyceride levels get increased. Complex carbohydrates like whole grains and vegetables (beans) are used slowly, just when we need them for fuel. Complex carbohydrates are a great source of B vitamins, and are of real importance for the health of the nervous system

Fats

DT: We need some fat. The good ones are monounsaturated like olive oil, canola oil and walnuts. They don't raise total cholesterol and bad cholesterol, but they do raise good cholesterol in normal weight people. They should, however, be used in moderation in people who have high triglycerides. Omega 3 fatty acids found in fish, flaxseed, soybeans and canola oil seem to lower triglycerides.

Saturated fat in whole milk dairy products, skin on chicken and turkey and fatty meat are almost guaranteed to raise cholesterol in people on protease inhibitor therapy. When we sleep at night there is an enzyme that kicks in and takes all the saturated fat and makes cholesterol. Too much cholesterol goes to the arteries and causes blockage. You also have to watch out for hydrogenated fat like solid vegetable shortening and margarine. It is not made from saturated fat, but the chemical process that makes it hard at room temperature makes it saturated. Fast food chain French fries and movie popcorn are famous for the use of hydrogenated fat.

Eggs are high in cholesterol but research shows that dietary cholesterol from eggs is really poorly absorbed and an egg a day might be okay. Be careful if you are diabetic. Diabetes seems to alter cholesterol transport in the body, potentially making eggs more risky.

Protein

DT: It's critical to eat enough protein, lean meats, chicken, turkey and lots of fish. Beans are a good source of both protein and fiber. Other good protein foods are all nuts including peanut butter (monounsaturated fat) and soy products. Skim milk dairy products are another source of protein.

Fruits and vegetables

DT: It's good to eat lots of vegetables and fruits. They are loaded with vitamins, minerals, antioxidants, phytochemicals and fiber that all have an important role in a healthy diet. Try to eat fruits and vegetables in a variety of colors every day so you don't miss out on any of the nutrients. There is antioxidant power in all those colors.

Exercise

DT: Exercise is very good. Aerobic exercise 45-60 minutes a day. Power walking, treadmill, biking or roller blading are good aerobic workouts that are good for lowering blood sugars and blood lipids. Everyday exercise increases insulin sensitivity (helps sugar processing) by as much as 30%. Resistance exercise is better for building muscle mass and preventing muscle loss. While in most cases of lipodystrophy overall weight loss may not be desirable, there might still be an improvement in sugar processing (insulin sensitivity) if the fat round the waist can be reduced through exercise.

Vitamins and minerals

DT: A good multivitamin with mineral supplement is basic for people with HIV. A high antioxidant formula is even better. The antioxidants are good for HIV and are a preventative therapy for heart disease and cancer. Taking separate supplements is troublesome and confusing when one supplement can include everything.

Supplements
The idea that these supplements may reduce the symptoms of lipodystrophy is based on what's known about how they work in the body. No research studies have been done, but individual stories suggest they might sometimes be able to help.

DT: L-carnitine 2 grams/day helps the body to increase fat burning in the cells. This could help to lower triglycerides. It also seems to be helpful in preventing neuropathy associated with the "d" drugs like ddI (Videx), ddC (Hivid) and d4T (Zerit). L-carnitine is available as the prescription drug Carnitor.

NAC at 2000-4000mg/day may be useful for the acquisition of lean body mass and the prevention of lipodystrophy. Seems to be especially effective in combination with anabolic steroids or growth hormone (muscle building drugs). NAC is a precursor of glutathione, an antioxidant that works with insulin to manage blood sugar levels.

Chromium is involved in the body's processing of carbohydrates and fats. No studies in people with HIV but studies in non-insulin dependent diabetics indicate that doses from 200-1000 mcg are effective and safe. It may increase sensitivity to insulin by 40% and may help to reduce the risk of diabetes.

Niacin is one of the B vitamins that seems to work with chromium to reduce diabetes risk and independently to help lower cholesterol. You should not take a separate niacin supplement, however, but a B vitamin complex that includes niacin. It is always wise to take a B complex 25-50 supplement rather than single B vitamins. The B vitamins as a group are referred to as the stress vitamins. An important reason to take the Bs is to prevent neuropathy (nerve damage) and stress. Some B vitamins are also protective against heart disease.

Alpha lipoic acid (also known as thioctic acid) plays a role in sugar processing. It seems to increase the muscle permeability to glucose thus helping to spare insulin. There is less pressure for insulin to do all the work. Insulin insensitivity and glucose intolerance seems to be one of the causes of lipodystrophy. Alpha lipoic acid is also used for treatment of both diabetic neuropathy and HIV peripheral neuropathy.

Omega 3 supplements 2-3 grams/day helps to lower triglycerides. If you don't like fish, omega 3 is also available in flaxseed, flaxseed oil pills (2 grams/day) or ground flaxseeds (1-2 tablespoons/day). Caution: don't use these supplements (both fish oil and flaxseed oil) if you have low platelets, as omega 3 is a blood thinner. You have to be careful with other blood thinners too like vitamin E (high dose), garlic, gingko biloba, feverfew, aspirin, ginger and prescription blood-thinning drugs like Coumadin.

The latest protease inhibitor to be approved is called Agenerase (also known as amprenavir). It is not widely known that each Agenerase pill contains 109 IU of vitamin E per capsule. This means that if you're taking Agenerase, you're also taking 1,744 IU of vitamin E per day. Because vitamin E can thin the blood, you should not take any other vitamin E supplements in addition to Agenerase. You have to be careful with other blood thinning supplements too, such as garlic, gingko biloba, feverfew, aspirin and ginger. People taking blood-thinning drugs should talk to their doctor about the amount of vitamin E in Agenerase to make sure it isn't dangerous to your health.

Three recent studies have investigated switching from a protease inhibitor to an NNRTI type anti-HIV drug in people with lipodystrophy. The purpose of these studies was to see if switching helped reduce or eliminate lipodystrophy-associated symptoms.

Two studies switched people's protease inhibitor to Viramune (nevirapine). Everyone kept taking two NRTI drugs as part of their combination. In both of these studies, fat (cholesterol and triglyceride) levels in the blood dropped after the switch to Viramune. People also reported improvements in body shape changes, although no-one felt that their appearance had totally returned to normal. Out of a total of 34 people in these two studies, only one had a small viral load increase after switching to Viramune. In this individual, viral load increased from less than 500 copies to 546 copies. Further follow-up will be needed to see if this person's HIV is becoming resistant to the drugs they're taking.

Another study switched 12 people with lipodystrophy from Crixivan to Sustiva. Most of these people were also taking d4T (Zerit) and 3TC (Epivir) and these drugs were not changed. Eight people in this study have now been followed for 6 months after switching. All eight still have viral loads less than 500 copies. The researchers noted improvements in the appearance of participants with tissue loss. Reductions in belly size varied, but were generally small. Importantly, cholesterol and triglyceride levels both increased after the switch. Although both cholesterol and triglyceride levels began to fall over the next six months, they were still much higher than normal.

Unlike Viramune, Sustiva has been reported to increase cholesterol levels in other studies. This fact may make Viramune a better choice for people needing to switch treatments due to high cholesterol levels and lipodystrophy.

Stepping Down
For the past couple of years, standard anti-HIV treatment combinations (often called HAART) have usually included two NRTI type drugs (AZT, ddI, ddC, 3TC, d4T) and a protease inhibitor (Crixivan, Fortovase, Norvir, Viracept). Because these combinations can be complicated to take, a number of studies have tried "stepping down" - seeing if just one or two drugs can keep HIV under control after a person has been on HAART for six months to a year. Unfortunately, none of these studies have shown good results. After stepping down to fewer drugs, a significant number of people had increases in viral load.

Recently, a group of French researchers tried a slightly different approach. Instead of stepping down to less drugs, they changed the protease inhibitor to an NNRTI drug, similar to the lipodystrophy studies just described.

Eighteen people were included in the study. All study participants had been taking a HAART combination including a protease inhibitor for at least a year. Study participants were also required to have had a viral load of less than 200 copies for at least six months. No-one in the study was allowed to have taken an NNRTI type drug before.

Sixteen people switched their protease inhibitor for the NNRTI drug Viramune (nevirapine) given at a dose of 400mg once-daily. Viramune is usually given twice-daily, but recent studies have suggested that once-daily dosing may work just as well. The other two participants switched to Sustiva (efavirenz) at the standard dose of 600mg once daily. Everyone stayed on the same two NRTI drugs that they were already taking (d4T+3TC, AZT+3TC, or d4T+ddI).

After the switch, study participants have been followed for an average of about four months. The study is ongoing. So far, all but one participant has maintained viral load levels less than 200 copies. The one person whose viral load increased to 38,000 was found to have taken the NNRTI drug called Rescriptor (delavirdine) several years ago. The likely explanation is a problem called cross-resistance. HIV can mutate in ways that prevent an anti-HIV drug from working. This is called drug resistance.

In terms of side effects, only one of the 16 study participants who took Viramune developed a rash. The rash was mild and went away on its own. Other studies have suggested that Viramune-related rash can be avoided by giving either antihistamines, or low-dose prednisone during the first two weeks of treatment. One person was started on Sustiva, but changed to Viramune after 3 days due to severe vertigo (dizziness).

All-in-all, switching from a protease inhibitor to Viramune or Sustiva looks like a promising strategy for simplifying HIV treatment. Six of the eighteen study participants had a history of T-cell counts less than 50, which also suggests that the strategy can work for people at varying stages of disease. Larger studies are now needed to confirm these results.

People who have never participated in a research study, or who would like to know more about the process of testing HIV treatments, can request a free copy of The Network's handbook, Should I Join an AIDS Drug Trial?. This handbook includes important questions you should know the answers to before you agree to participate in any clinical trial. The Summer 1999 edition of The Experimental Treatment Guide is also available free of charge to people interested in knowing about the different studies that are now open.

When HIV mutates in a way that stops one NNRTI type drug from working, it often means other NNRTI drugs won't work, either. This is what's known as cross-resistance. The same problem can happen with protease inhibitors. If you stopped taking an NNRTI drug while it was still working, however, it should be possible to start taking that drug again, or switch to another NNRTI type of drug.

There are many "switching studies" that are closely looking at the effects of this treatment strategy. In most cases, however, you will not be eligible for a study if you have already switched to another class of drugs, even for a short time. Ask your doctor if a clinical trial would be a good idea if you were about to switch drugs. You would be making a very valuable contribution to everyone's knowledge of HIV treatment.

Stopping Prophylaxis
For information about research studies that are looking at the benefits and risks of stopping all HIV medications entirely, contact The Network at (800)734-7104. Although very preliminary studies suggest that there may be some benefit to stopping and starting HIV medications under very specific conditions, researchers still know very little about the short or long term effects.

This article appeared in the July 1999 issue of Body Positive. If you'd like more information about their excellent monthly magazine, or their services, call them at (212) 566-7333 or e-mail them at bodypos@aol.com.

The new draft PHS Guidelines on the prevention of opportunistic infections can be downloaded from the Internet at www.hivatis.org.

While studies have shown that HAART (Highly Active Anti-Retroviral Therapy) combinations can increase T4 cell counts, doctors have been cautious about stopping prophylactic (preventive) treatments like Bactrim for PCP. PCP prophylaxis is usually prescribed if the T4 cell count drops below 200. Several studies have now suggested that if HAART increases T4-cells to over 200 for an extended period of time, PCP prevention can safely be stopped.

The recommendations for starting PCP prevention have not changed: a T4-cell count of less than 200 or a history of thrush. However, a new section has been added on stopping PCP prevention. This section says that "providers may wish" to stop PCP prevention when an individual's T4-cell count has stayed over 200 for at least 3 - 6 months. In terms of restarting PCP prevention, the guidelines suggest the same rules as for starting - i.e. if the T4-cell count drops below 200 again.

Recommendations for preventing mycobacterium avium complex (MAC) have also changed. MAC used to be a common opportunistic infection in people with low T4-cell counts. The symptoms of MAC can include weight loss, fevers, chills, night sweats, swollen glands, abdominal pains, diarrhea and overall weakness. The risk of developing MAC is highest in people with less than 50 T4-cells. The PHS Guidelines recommend preventive therapy for MAC if the T4-cell count gets this low. The recommended drugs are either Biaxin (clarithromycin) or Zithromax (azithromycin).

As with PCP, the new PHS Guidelines contain the first ever recommendations for stopping MAC prevention. The guidelines say that it is "reasonable to consider" stopping MAC prevention if the T4-cell count increases to over 100 cells for at least 3 - 6 months. The guidelines also recommend restarting MAC prevention if the T4-cell count drops below 50 again.

The other HAART-related change in the PHS opportunistic infection guidelines relates to cytomegalovirus (CMV). CMV is a herpes virus that can cause illness, most commonly when the T-cell count is less than 50. CMV causes retinitis, an eye infection that can lead to loss of vision. Standard treatment for CMV involves drugs given intravenously, and ongoing "maintenance" treatment is normally needed to prevent CMV from coming back. Several studies have found that when HAART increases T-cell counts to over 100 - 150 cells, maintenance treatment for CMV may not be so important.

The PHS guidelines are cautious about this information, because active CMV disease can be very serious. However, the guidelines note that stopping maintenance treatment "may be considered" if there is a sustained T-cell increase to over 100 - 150 cells. The guidelines point out that any decision to stop CMV maintenance therapy should be made in consultation with an experienced eye doctor (ophthalmologist). There are a number of factors that need to be taken into account, including how sight-threatening the CMV infection might be.

Some Research Questions
Some research studies that have recently opened are called treatment strategy trials. They are trying to answer questions that will possibly make HIV treatment easier to manage, safer, and more effective. Getting into one of these studies usually depends on what treatments you've already taken, but there are now many more programs for people who have already taken other anti-HIV drugs. Some of these studies are using promising new experimental protease inhibitors, including ones that are made in a different way than the approved protease inhibitors.

These are some of the questions that new clinical trials are trying to answer:

• Is it useful to take only NRTI type drugs instead of a combination that includes a protease inhibitor?

• Is it possible to "step-down" from HAART combinations that include protease inhibitors, to simpler anti-HIV treatments?

• What new treatments work best for people who have already taken available anti-HIV drugs?

• Is it possible to stop and start HAART as a way to try and boost the immune system so it does a better job of controlling HIV?

• Can vaccines boost the immune response against HIV, so that HAART is no longer needed?

These are some of the specific treatment strategy questions being asked in clinical trials. They will be answered much faster and most likely more reliably if people who are currently taking HIV treatments, as well as people who have never taken HIV treatments, consider participating in a clinical trial. If you'd like more information about the pros and cons of taking part in a trial, call the Network and ask for a free copy of "Should I Join A Clinical Trial?"

None of the currently approved protease inhibitors, or other types of anti-HIV treatments are able to completely eliminate HIV from the body. A new generation of protease inhibitors is now being looked at in many newly opened study programs at doctors' offices, clinics, and research centers throughout the United States. In some cases, these studies are looking for people who need new treatment options because they are not responding well to already approved treatments. This has always been one of the main reasons that someone would consider joining a research study. In other cases, these newly opened treatment studies are looking for people who have never taken anti-HIV drugs (researchers describe this as being "treatment naive"). There are sometimes exceptions to what researchers consider naive, so it's worth checking out what clinical trials are currently open.

Second generation protease inhibitors will probably be taken once, or twice a day. The hope for these protease inhibitors is that HIV will have less of a chance to develop resistance to them, and that any resistance that does develop will be different than the resistance caused by the already approved protease inhibitors.

Some of the new protease inhibitors that are now being studied are tipranavir, L-756,423, BMS232632, and ABT-378(r). Several of these studies are described below. There are many other ones as well, so contact The Network for more information.

L-756,423
This trial will compare a new experimental protease inhibitor, L-756,423 to the already approved protease inhibitor Crixivan. The drug company Merck makes both of these drugs. The drug L-756,423 is believed to stay in the blood longer than Crixivan, so researchers are trying to see if it should be taken once or twice a day. Everyone in the study will take the already approved drugs 3TC (Epivir) and d4T (Zerit). The first group will take Crixivan and L-756,423 once a day. The second and third groups will take different doses of Crixivan and L-756,423 twice a day. The fourth group will be given Crixivan three times a day. All the drugs in the study are pills. Everyone in the study will take his or her drugs with a regular or light meal.

BMS232632
The makers of ddI, Bristol-Myers Squibb, have chosen to use a once a day dose of ddI (Videx) in their new protease inhibitor study. The protease inhibitor is called BMS232632 at this point. The control group in the study takes a combination of ddI once a day, along with d4T twice a day and the approved protease inhibitor Viracept (nelfinavir). The other three groups in the study take ddI once a day, along with 200 or 400 or 500 mgs of the experimental protease inhibitor BMS232632 once a day. Everyone also takes d4T twice a day.

ABT-378(®)
One of the promising second generation protease inhibitors currently being developed is Abbott Laboratories ABT-378(r). In clinical trials conducted so far, the drug had a very strong anti-HIV effect. The majority of people who took the drug reduced their HIV viral levels to undetectable in a matter of weeks, and had considerable increases in their T4 cell counts. It is hoped that ABT-378 will be effective against strains of HIV that are resistant to other protease inhibitors, although the HIV virus of the people in the studies has, in some cases, show signs of mutations that could lead to resistance. Clinical trials have opened for people who have never taken any HIV treatments before, as well as for people who have. There is no expanded access program for the drug at this time. Contact The Network at (800)734-7104.

tipranavir
The second generation drugs being studied in clinical trials described below have specific eligibility criteria. For example, if you have already taken a protease inhibitor combination, you may not be eligible for some studies. Other studies, however, have gone out of their way to test new drugs in people who have already taken quite a few other HIV drugs.

Some studies are looking for people who are treatment naive, although the definition of naive doesn't always mean that you can never have taken the drug. In many studies, for example, it is alright if you have taken a protease inhibitor for less than 2 weeks or ten days. For example, if you tried taking a protease inhibitor for a week, then stopped because you couldn't tolerate it , most studies will still consider you naive. This is often also the case with studies that involve NRTI type drugs such as ddI or d4T.

Links to other online HIV/AIDS support groups can be found on Marty Howard's HIV/AIDS HomePage at http://www.smartlink.net/~martinjh/suppfrm.htm and through the AIDS Electronic Global Information System (AEGIS) website at http://webboard.aegis.com:81/~1/login.

Another great web site for long term survivors is www.onelist.com. I was introduced to this web site through gateway.net. Every morning when I sign on to this web site, which is more like a newsgroup, I find poems and kind words from other long term survivors. I recommend these sites to anyone that wants information about HIV/AIDS or is living with HIV/AIDS. If you have a computer with America Online, go to "Find a Chat", then you click on "Special Interests", then you click on "View Chats", then you scroll down the list till you find the two rooms that have made a big difference in my life. One room is called "Health HIV," and the other is called "Health AIDS." Most times the HIV room will have someone in it.

For someone like me that has been living with HIV/AIDS for so many years, I thought I had been to enough support groups and therapy to last a life time. Until, that is, I found the HIV/AIDS chat rooms on the Internet.

About 2 months ago, when I was able to get back online after a long break, I decided to try a chat room. This was something I had never done before. To my surprise, my internet provider American Online (AOL) had two chat rooms that were of interest to me. One is called Health HIV and the other is called Health AIDS.

I will tell you how to access these rooms when I finish telling you what a joy it was to enter a chat room and talk with people that were seeking information and giving it as well. I have been surfing the net for a few years, but never even thought about entering the chats because I didn't think I would like them. Well, to my surprise it was a great experience. There are people there from all over the world. Some as far as Australia, all of us sharing something in common. It was the best form of support group I had ever experienced. If you want to keep your anonymity, it is the best.

It got so I was going in everyday, sometimes 2 or 3 times a day. People from all walks of life from everywhere can be found there. There are even those that are not infected but affected by AIDS that just come in there to learn or give support, what ever you need, it's in there. What a find!

I was a little shy my first time and just sat there and watched the screen scroll up faster and faster, then I realized that I had something to give also. So, I decided to introduce myself. When I told them how long I've been living with this virus everyone seemed to just gather around and squeeze information out of me. I felt like a celebrity.

There are the ones that are in recovery and are trying so hard to stay clean, and those that are married to a person with HIV, or a mother of a PWA or even a son or daughter or a single parent that has lost their partner to the complications of AIDS, just wanting to share. My fingers cannot type fast enough when I'm in that chat room.

There are also questions about medications, transmission and the mental torture that one goes through waiting for the results of an HIV test. Every time someone comes into the room and says "I just got tested for HIV", it seems like you can just feel the embrace in the room. Everyone starts talking to this person, telling them that we've been there and not to worry. There are those that come in and say "I don't want to live anymore, I just found out that I'm HIV+". I can't express in words the warmth that comes out of the people that are there. When we finish talking to them and consoling them, they leave with such a better attitude. They don't want to die anymore. They know that there is life with HIV. That person is given a wealth of information from everyone in there, from all over the world they are there giving love and consolation and advice on how to deal with the news they just received, after all we have all been there, so we talk and talk. Sometimes hours go by and I don't even realize that I've been on that long.

For those that are infected and are dealing with side effects from a certain medication, I can give them The Network's and other web sites and they always come back and find me either by sending me an email or wait until I come into the chat room, and thank me for giving them information that maybe they didn't think to ask their doctors about. You can always find someone in the room that is going through the same thing that you are.

Example: The Sustiva Crazies. I have told many people how I survived through the first month or so with the Sustiva Crazies, and have also gotten some good tips from others that are going through the same thing. One member came in one night and we were discussing the Sustiva Crazies, and they said that their doctor had put them on a medication for people who suffer seizures called Neurontin. That helped them get through the Sustiva side effects. The information you get in this room is priceless. The reward is when they come back and thank you and tell you, "Hey, it worked for me, thanks so much". I hear the word thanks a lot in that room, it is very rewarding.

Other rooms to chat on AOL are the Positive Living Room. That room is hosted every day from noon to 2pm and in addition to the general chat and support of the Positive Living Room they also offer specific topic chats and support groups meet in the Positive Circle. You go to AIDS AND LIVING, and you will find all sorts of Chats there. They even have a page that teaches you the lingo that is spoken in rooms. Example: J, BRB (Be right back). BBL (Be back later) the list goes on and on. They teach you the shorthand of chatting.

For those of you that have computers and want an education on HIV/AIDS I implore you to join us in the HIV or AIDS Chat room, or Positive Living Room. You will not be sorry.

The best times to come in are in the morning. People sign on before they start their day getting their kids off to school or going to work or to the doctors or just having their coffee. We laugh and sometimes I swear I can hear the tears of frustration through the words that they type, but we are there to pick each other up and get on with our lives.

The worst times to come in is in the afternoons when kids get out of school. We get young kids that come in there and call us names and curse us, but we are like a family - we stick up for each other and condemn those that do this. I guess nothing is perfect. Were it not for the times when those mean kids come in and start torturing us, it would be the perfect place at all times for someone that needs a support group and just doesn't want to go to one that is public.

I fix my coffee in the morning and sign on and someone is always there, they might be in a good mood they might not be, but when you enter they always have a kind word for you. Some of us have even exchanged phone numbers and we call each other just to see how the other is doing, like on days when I'm busy and don't have a chance to sign on, for sure my phone will ring, and it will be someone I met in the chat room. A few even find love in the room, especially if they live in the same city. Try it, it just might make a difference in your life the way it has in mine. I am truly helping people and they are helping me.

A new ddI (Videx)
The drug ddI, now more commonly known as Videx, has been approved as an anti-HIV treatment for many years. Videx is often used as part of a combination of drugs to treat HIV. One problem with the current version of Videx is that it comes with an antacid "buffer," which often causes diarrhea and stomach upset. The reason for using a buffer is that too much acidity in the stomach stops Videx from getting absorbed properly. Videx must also be taken on an empty stomach. Because of these problems, a new version of Videx has been developed. The new form of Videx is called "enteric-coated." It is specially designed so that stomach acidity does not affect the way the drug is absorbed. There is no antacid in the enteric-coated Videx pills. They can be taken either with or without food. New clinical trials of enteric-coated Videx are opening around the U.S., call The Network for a referral.

Hepatitis Drug Alert!
A warning has been issued about ribavirin, a drug prescribed along with injectable alpha interferon as a treatment for Hepatitis C. A company called Schering-Plough sells ribavirin/interferon in a package called Rebetron. Ribavirin may cause deformities and birth defects in children born to parents who use the drug. Both men and women using the drug are strongly advised to use one or more barrier forms of contraception to prevent pregnancy while taking ribavirin. Because the drug stays in the body a long time, pregnancy should be avoided for six months after stopping the drug. Contact your doctor if you need more information about the possible pregnancy risks associated with ribavirin.

In a related story, ribavirin was up until very recently only available from Schering Plough as part of their expensive Rebetron package. Thanks to the work of a group called the Hepatitis C Action & Advocacy Coalition (HAAC), ribavirin is now available separately at 20% (one fifth) of Schering's price. This ribavirin is available by mail order from Fisher's Specialty Pharmacy Services in Pittsburgh. Fisher's can be reached toll-free at (888) 347-3416. They also have a toll-free fax number: (877) 231-8302. Fisher's will work with you and your insurance provider to make sure the drug is covered.

Tipranavir Study Opens
For several years the drug company Pharmacia and Upjohn has been developing a new kind of protease inhibitor that may work against HIV that has become resistant to the approved protease inhibitors. The drug is called tipranavir. There has recently been encouraging information about tipranavir from test tube studies. In these studies, most HIV samples that were resistant to all the approved protease inhibitors were still effectively blocked by tipranavir. In terms of side effects, headache and diarrhea were reported by some participants in early safety studies. A new study of tipranavir is ongoing for people who have already used at least two protease inhibitors. Participants must have the option of using one new NRTI type drug, and one new NNRTI type drug. Participants must also have a CD4 count over 50, and a viral load over 5,000 copies.

The study divides participants into two groups. One group will get tipranavir at a dose of 1200 mg taken twice a day, along with 100 mg of Norvir twice a day. The second group will get 2400 mg of tipranavir twice a day along with 200 mg of Norvir twice a day. In addition, both groups will take one new NRTI and one new NNRTI. Previous studies have shown that Norvir boosts tipranavir levels in the body and allows for simpler twice daily dosing.

Ultra-Sensitive Viral Load Test Approved
A new, improved version of the HIV viral load test has been approved by the US Food and Drug Administration (FDA). The previous viral load test could only detect HIV if there were more than 500 copies of HIV genetic material (RNA) in the blood sample. The new test is called "Ultra-Sensitive" and can find as few as 50 copies of HIV RNA in a blood sample. There is a Patient Assistance Program for people who need help getting access to the viral load test. The number to call for more information is 1-888-TEST-PCR (1-888-837-8727).

Free Directory
The Network's directory of clinical trials for men, women and children, The Experimental Treatment Guide, has recently been completely updated. There are many new studies that few people are aware of. This directory is free to anyone who would like a copy. A $10.00 contribution to cover printing, postage and research costs is suggested if you live outside of New York, or if you can support this important resource. The New York State Department of Health AIDS Institute generously supported the publication of the Summer 1999 edition of this directory.

Methadone and Anti-HIV Drugs
Some anti-HIV drugs can affect the levels of methadone in the body. Two recent reports have shown that the NNRTI drugs Viramune (nevirapine) and Sustiva (efavirenz) can reduce levels of methadone, sometimes leading to withdrawal. In a study of people taking Viramune and methadone, the methadone dose had to be increased to over 150mg a day to avoid symptoms of withdrawal. A recently presented study found that Sustiva also reduces methadone levels. In five people taking methadone maintenance and Sustiva, the methadone dose had to be increased an average of about 22mg to avoid symptoms of withdrawal. The increase in methadone dose varied on an individual basis, from 5mg to 50mg.

The other anti-HIV drugs that are known to reduce methadone levels are the protease inhibitors Norvir (ritonavir) and Viracept (nelfinavir). Both of these protease inhibitors reduce methadone levels by 30-40%. The protease inhibitors Crixivan (indinavir) and Fortovase (saquinavir) do not decrease methadone levels. Crixivan and Fortovase may actually increase methadone levels slightly, but study results have not yet been presented.

Another recent study found that methadone may reduce the levels of the anti-HIV drug ddI (Videx). In this small study, people taking methadone had ddI levels that were about 50% less than normal. The researchers that conducted the study suggested that it may be necessary to increase the dose of ddI in people taking methadone. Further studies are needed to find the correct ddI dose.

New Norvir Capsules
Abbott Laboratories, the makers of the protease inhibitor drug Norvir, have received approval from the FDA to market a new Norvir capsule. This is important for several reasons. The previous Norvir pills were in very short supply due to problems with making the drug. In the meantime, many people have had to switch to a very bad tasting liquid formulation of the drug, which they usually had to put into gelatin capsules to avoid getting the taste on the drug in their mouth. The new capsules should make taking the drug much easier. In addition, several experimental drugs currently being studied, as well as studies of new combinations of drugs, are using small amounts of Norvir as a way to greatly increase blood levels of other anti-HIV drugs. For example, one study is looking at 200 mg a day of Norvir added to a Crixivan regimen. For information on these, or other new studies contact The Network at (800) 734-7104.

Fusion Inhibitor Study
Fusion inhibitors may provide a useful HIV treatment option for people who are treatment experienced. The results of studies of T-20, the first fusion inhibitor to be tested in people, were good. It was discovered during these first studies that the drug can be given as shots instead of intravenous infusions. Phase II studies of T-20 in people who have already taken one or two protease inhibitor combinations have begun. Everyone in this study (T20-206) will receive a combination of the drugs Sustiva, Agenerase (amprenavir) and Ziagen (abacavir). T-20 injections are given twice a day. Three of the four groups in this study will receive different doses of T-20 to see how well it works, and how well it combines with the other three drugs used as the foundation, or backbone of the study. The fourth group will not receive T-20, but will still take the other three drugs. There are no placebo shots used in this trial. Call the New York University Clinical Trials Unit at (212) 263-6565 for more information.

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