| Treatment News Merck Vaccine Studies for HIV+ |
To be eligible for this study you must be on a potent anti-retroviral drug regimen and have had an undetectable RNA viral load level (less than 500) for at least 12 consecutive months. You must have at least 500 CD4 cells and not have had less than 200 in the last 12 months. Participants must be negative for Hepatitis B surface antigen, and negative for Hepatitis C antibodies. Women cannot be pregnant, breastfeeding, or planning to conceive during the study period. People interested in obtaining information about where the study is available should call the Merck National Service Center at (800) 672-6372. In New York City, Cornell, New York University, and Mount Sinai are expected to conduct this study.
Different strategies have been used to develop vaccines to prevent HIV infection. Although none of the vaccines being studied has yet been shown to prevent someone from becoming HIV-positive, researchers have learned a lot about how the immune system reacts to vaccines. They believe that a very strong, very specific response by the immune system is required. Using a deactivated virus that can cause a cold-like illness (the adenovirus), along with bits and pieces of the HIV virus, Merck has begun testing a vaccine that could provoke a strong, anti-HIV response. This might prevent HIV-infection, as well as treat someone who is already HIV-positive.
Merck studied their vaccine in a group of monkeys. One group of monkeys was given the vaccine, and then challenged with a very large dose of an especially strong, HIV-like virus. Another group of monkeys - the control group — was only given a very large dose of the same virus. Most of the monkeys who just got the virus quickly developed AIDS and died. The group of monkeys that got the vaccine first, then were challenged with the virus, however, became infected but had low viral load, did not lose CD4 cells, and remain healthy at this time. Researchers don't know how long the vaccinated monkeys will stay healthy, but the results were promising enough that Merck began testing the vaccine in HIV-negative people.
Merck's vaccine is the first of its kind to move into studies in HIV-positive people. The studies are testing a technique called prime/boost. The prime introduces fake pieces of HIV's genes (called naked DNA) into the body. Naked DNA, by itself, may not produce a strong enough response from the immune system, so a boost is used. The boost is a modified form of adenovirus (a cold virus) with some HIV genes incorporated into it. The adenovirus base is a vector used to carry the HIV genes directly to the immune system. There are other vaccines in development using a prime/boost strategy, but with different vectors. The idea is to target untrained CD4 cells to recognize the pieces of HIV as a threat. These CD4 cells will then begin to reproduce, creating millions of cells all of which are targeted to kill HIV.
Because no one really knows if the vaccine is safe, or even what dose to study in people, Phase I studies are being conducted of different variations of the Merck vaccine. A Phase I study helps to determine if a product is safe, how it is absorbed into the body, and what the proper dosing range is for that particular product. In Merck's study, different combinations of adenovirus, HIV proteins including gag, pol and nef, and genetic material (DNA) from the HIV virus will be tested to determine the best mix of ingredients, and the best prime/boost strategy to use for their vaccine.
| Network News New Staff and New Programs |
New York City experienced case managers are invited to inquire about available positions at The Network by calling a(800)734-7104.
Several staff changes have occurred at the Network over the past few months, temporarily delaying our publication schedule. In April, the Network welcomed Tracy Swan as the new Access Project Director. Richard Jefferys, former Access Project Director has accepted a position on the Network's Board of Directors. Richard now works as a senior writer at the International AIDS Vaccine Initiative (IAVI). If you would like to contact Richard Jefferys, he can be reached at (212) 947 -1056 or via e-mail at rjefferys@iavi.org. You may also leave a message for him at The Network.
Tracy Swan will continue Richard's work as the coordinator of the Network's intensive treatment counseling efforts, which include a new Hepatitis C (HCV)/HIV treatment education, counseling and adherence program, and a new HCV initiative of the agency's national treatment access and advocacy program, The Access Project. Tracy is a member of the Community Constituency Group (CCG) of the Adult AIDS Clinical Trial Group (AACTG).
The Network's Case Management Program continues to assist clients to access the care and resources they need. Our experienced case managers help clients to keep their private insurance, or to enroll in Medicaid or ADAP. If you have questions about the many other services available to people with HIV who receive services in New York City, give us a call at (800) 734-7104.
In addition, The Network will continue to provide information and counseling regarding experimental HIV treatments and access programs, although the printed version of The Experimental Treatment Guide is being redesigned. In the interim, Community Research Initiative on AIDS (CRIA) now publishes a directory for New York State residents that is available by calling (212)924-3934, ext 123.
Announcement
Policy Director Position - Treatment Action Group
212.971.9022 - phone
212.971.9019 - fax
e-mail: tagnyc@msn.com
The Treatment Action Group (TAG), a New York-based non-profit organization focusing on AIDS research and treatment policy, seeks a candidate for the position of Policy Director.Founded in 1992, TAG is the nation's leading organization focusing solely on AIDS research and treatment advocacy. The Policy Director has experience in any combination of the areas of AIDS research, treatment, policy, advocacy and education; public health; Federal Affairs including experience working in or with the executive and legislative branches of government; or experience in a related community based non-profit, public health, government, or private sector organization. Interested candidates should send a letter expressing their qualifications and interest in the position with a résumé/C.V. and three references with contact information to Policy Director Search, c/o Regina Gillis, Treatment Action Group, 350 Seventh Ave., Suite 1603, New York, NY 10001.
| Treatment News New HIV Treatment Guidelines |
The new guidelines are available on the Internet at: http://hivatis.org/trtgdlns.html.
Since 1997, regularly updated guidelines on how to use anti-HIV drugs have been available in the US. These guidelines are produced by a panel of experts brought together by the US Public Health Service (PHS) and the Henry J. Kaiser Family Foundation. One of the most difficult questions this panel has to consider is: when should anti-HIV drugs be started? The guidelines only make one definite recommendation. If someone has symptoms of immune dysfunction (like the fungal infection thrush, for example) or an AIDS diagnosis, anti-HIV treatment is recommended.
For people that have not yet developed symptoms, the question of when to start treatment is more complicated. A few years ago, some doctors thought that just about all HIV-positive people should be taking anti-HIV drugs. Now that it's known that HIV drugs can cause side effects which only show up after long-term treatment, people are becoming more cautious. Up until recently, the PHS guidelines have said that anyone with a viral load over 20,000 or a T-cell count less than 500 should be "offered" treatment.
The guidelines also noted that some experts would wait until the T-cell count is under 350, and evidence of HIV disease progression is seen before starting treatment. The new PHS guidelines, however, recommend starting treatment if the T-cell count falls below 350 or if the viral load increases to over 55,000 copies (using the more commonly used Amplicor PCR viral load test - the equivalent number on the bDNA viral load test would be 30,000 copies).
Several new treatments are also included among those recommended as first line therapy, including the combination of Crixivan and Norvir, Fortovase and Norvir, and the newly approved protease inhibitor Kaletra (which is lopinavir and norvir).
In addition, the Perinatal HIV Guidelines Working Group has developed revised guidelines for the clinical use of antiretroviral agents in the treatment of pregnant women. These guidelines are available at http://hivatis.org/request.html/list
| Community Forum HIV, Hepatitis and Liver Health |
Every month The Network co-hosts community meetings with Treatment Action Group (TAG), Community Research Initiative on AIDS (CRIA), and Gay Men's Health Crisis (GMHC). The next forum is June 13th, from 7:00 to 9:00. The topic is HIV, Hepatitis and Liver Health. All forums are free and open to the public. The forums take place at St. Vincent's Hospital, Cronin Building, 10th floor auditorium. Use the entrance on the south side of 12th street, just east of 7th Avenue. The forum topic for July is considerations and concerns regarding recreational drug use and HIV treatments.
| Treatment News Oral Valganciclovir (Valcyte) Approved as CMV Treatment |
The FDA has approved oral valganciclovir (Valcyte) for CMV retinitis treatment. This is the first oral treatment for both CMV retinitis induction and maintenance treatment. Currently, intravenous ganciclovir is used to treat CMV retinitis. After induction therapy, maintenance therapy is required. This usually requires ongoing intravenous therapy with ganciclovir, although an oral version of ganciclovir is available. The new valganciclovir pills will be used for both induction and maintenance therapy. The possible side effects of oral valganciclovir are similar to those of intravenous ganciclovir: low red and white blood cell counts, diarrhea, nausea, vomiting and fatigue. Valcyte is made by Roche, who says the drug should be available by mid-June.
| Treatment News
Ritalin and Cylert May Treat Fatigue |
The doctors that performed the study concluded that both Ritalin and Cylert can be useful treatments for HIV-related fatigue, but they stress that it's important to try and identify the cause of the fatigue first, in case it's a treatable condition like anemia (low red blood cells). The full title of this study is "A Randomized, Double-Blind, Placebo-Controlled Trial of Psychostimulants for the Treatment of Fatigue in Ambulatory Patients With Human Immuno-deficiency Virus Disease," by William Breitbart, MD and colleagues. The technical summary is available online at: http://archinte.ama-assn.org/issues/v161n3/abs/ioi00035.html
In a study published in the February 12, 2001 issue of a scientific journal called the "Archives of Internal Medicine", researchers report that the stimulant drugs Ritalin and Cylert can both be effective at decreasing fatigue associated with HIV infection. Fatigue is a common problem for people with HIV and can reduce quality of life. Fatigue can be linked to medications, medical and psychiatric conditions and other problems, but it's not unusual for severe fatigue to develop without any clear cause. There are several approved treatments for fatigue, depending on its' cause.
This new study included 144 people with HIV who had severe and persistent fatigue that was not associated with depression or other mental problems. Participants were started on either 7.5mg of Ritalin twice daily, 18.75mg of Cylert twice daily or one placebo capsule twice daily. Depending on how well people responded, doses were increased to a maximum of 60mg of Ritalin, 150mg of Cylert and eight capsules of placebo daily.
109 of the participants completed the study. Significant improvement in fatigue was reported in 41% (approaching half) of the Ritalin group, 36% (just over a third) of the Cylert group and 15% (about a sixth) of the placebo group. In addition to improvements in fatigue, people treated with either Ritalin or Cylert also experienced significant decreases in symptoms of depression and psychological distress and improvements in overall quality of life.
The major side effect of the medications was a feeling of hyperactivity and jitteriness, with over half of the people on Ritalin or Cylert reporting one or both of these symptoms. Either of these drugs may also significantly suppress appetite. Many of the study participants reported that these side effects lessened over time, but some people needed to reduce their doses. Only five people dropped out of the study due to side effects, two from the Ritalin group, two from the Cylert group, and one from the placebo group.
| Treatment News Stronger Warnings About Viramune Side Effects and Hepatitis |
The full text of the alert regarding these changes is on the FDA Web site at: http://www.fda.gov/medwatch/safety/2000/virahp.pdf
The labeling that comes with Viramune (nevirapine), a widely used anti-HIV drug that belongs to the class of drugs called NNRTIs, has recently been changed to strengthen the warnings about possible risks of liver and other toxicities, due to reported cases of serious or fatal reactions to the drug. The new label says that people taking Viramune need to be on the look out for symptoms of liver problems such as fatigue, feeling sickly and weak, loss of appetite and nausea. There have been rare reports of these symptoms progressing to jaundice and liver failure over a period of just several days. People with any signs or symptoms of liver problems are advised to call their doctor immediately, stop taking all their anti-viral treatments, and get liver function tests done as soon as possible.
The label also says that the first 12 weeks on Viramune are especially important, since about two-thirds of the severe reactions that have been reported have happened in that period. The label notes that experts recommend getting lab tests done:
- before starting Viramune
- two weeks after starting (before the dose is increased)
- four weeks after starting
- once a month for the next two months
- "frequently" after the first three months (at least every 2-3 months)
If liver toxicity occurs, Viramune should be permanently stopped and not restarted after recovery. The new label notes that increased liver function tests and/or a history of chronic hepatitis (B or C) infection are associated with a greater risk of liver toxicity from Viramune. The label also recommends that the drug prednisone should not to be used to try and prevent Viramune-associated rash, as a clinical trial found that this made the problem worse.
| Treatment News Zerit and Videx in Pregnant Women |
The FDA has issued a warning that pregnant women who are taking both Zerit (stavudine, d4T) and Videx (didanosine, ddI) may be at increased risk of fatal lactic acidosis. Lactate is a by-product made when the body processes glucose and fat. Usually, the body eliminates lactate. If there has been damage to the mitochondria, (the cell's power plant), the body isn't able to clear out lactate. If there is a build-up of lactate in the cells and organs of the body, it can be fatal. Lactic acidosis can also cause damage to the liver and pancreas. Early symptoms of lactic acidosis include shortness of breath, nausea, vomiting and pain in the stomach. Lactic acidosis can also occur in men, and in women who are not pregnant. The combination of d4T and ddI should be prescribed for pregnant women only in situations where the potential benefit outweighs the potential risk.
| Treatment News Peripheral Neuropathy |
Dr. Anthony Geraci, Assistant Professor of Neurology, Mount Sinai School of Medicine, Division of NeuroAIDS, gave a presentation on neuropathy at a recent community forum sponsored by The AIDS Treatment Data Network (The Network), Community Research Initiative on AIDS (CRIA), Gay Men's Health Crisis (GMHC) and Treatment Action Group (TAG).
The forum took place at St.Vincent's Cronin Auditorium in Manhattan. The next forum will also take place at St. Vincent's auditorium. On June 13th at 7:00, the forum topic will be HIV, Hepatitis and Your Liver. Some of Dr. Geraci's comments are presented here for those who were unable to attend. A summary of the entire forum is available at CRIA's web site, www.criany.org.
The symptoms of neuropathy include tingling, burning, numbness and shooting pain in the feet and occasionally the hands. Neuropathy can be caused by HIV itself, and certain drugs, including the anti-HIV medications ddI, d4T and ddC. Sometimes changing the drug combination may be helpful.
Although there is no proven treatment available for HIV-related neuropathy, there are several options available for managing the symptoms.
Neurontin (gabapentin), an anti-seizure medication, has been studied and proven effective in diabetic neuropathy, which is thought to be similar to HIV-related neuropathy. For night -time pain relief, Neurontin can be combined with topical pain relievers such as Lidocaine ointment and the Lidoderm patch. Capsaicin, available over the counter as Capzasin-P and Capzasin-HP, is another option for topical pain relief.
Other anti-seizure medications such as carbamazepine (Tegretol) and phenytoin (Dilantin) are useful for treating symptoms of neuropathy, but they can lower the amount of HIV-fighting medication in the body. Lamotrigine (Lamictal), another anti-seizure medication, works differently from carbamazepine and phenytoin to reduce symptoms.
Elavil (Amitriptyline), an antidepressant, can work if given at a high enough dose (most people will get pain relief with a 100 mg. dose), but can cause side effects if given at higher doses.
People who are in severe pain from neuropathy may need pain killers such as oxycodone, morphine or the fentanyl patch, which is worn on the arm. People who are in pain can get relief from these drugs without losing their ability to function. You can contact the Mount Sinai Neuro-AIDS Research Program at (212) 241-0784. Their web site is www.mssm.edu/neurology/neuroaids/index.shtml
| About Information Bulletin |
Information Bulletin was written and edited by Ken Fornataro, Tracy Swan, and Richard Jefferys with review and editorial assistance from Dr. Anthony Geraci, Mark Harrington, and Dr. Joseph Sonnabend.
The latest edition of Treatment Review is available online, and in print. In addition, several Spanish language publications are now also available. All Network resources are available by fax, e-mail, and at www.aidsinfonyc.org/network. There is no subscription fee to receive Information Bulletin, Treatment Review, The Simple Facts Sheets, or any of our other resources in English or Spanish. You can access The Access Project and its extensive databases on our web site. Publications are distributed on a regular basis when individual, corporate and/or government funding makes it possible to do so. If you would like to receive these materials on an ongoing, as available basis, please complete the form and fax, mail, or e-mail it back with whatever donation you can afford. Please indicate the amount of your donation. We accept credit card donations if you provide the card name, number, expiration date, and a phone number so we can contact you beforehand. No one is required to make a contribution to receive materials or services, although professionals, service providers, organizations, institutions and corporations are encouraged to make an annual donation. If you'd like materials in Spanish, or have other requests, please note that.
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