CAB UPDATE
the monthly newsletter from Clinical Directors Network : Fall 1997

Table of Contents

CDN Offers New Study of DMP 266 (Sustiva™)
CPCRA Acupuncture Study Results
Upcoming Events & Resources
Nutrition Workshop
SMART/EST Study
Children & HIV/AIDS
CAB Meetings
Goodbye and Congratulations

CDN Offers New Study of DMP 266 (Sustiva™)

Through a contract with DuPont Merck Pharmaceutical, the Clinical Directors Network HIV/AIDS Community Health Centers program is now doing a study of DMP-266 (also known as Sustiva™ or efiviranz), a new antiretroviral drug, at our network of community health centers in New York City and Newark, New Jersey. Read on for more information.

How DMP-266 Works. DMP-266 is a drug that works to block the growth of HIV by stopping one of its enzymes from working. It is in the class of drugs called non-nucleoside reverse transcriptase inhibitors, like nevirapine (Viramune™) and delavirdine (Rescriptor™). These drugs are also called NNRTIs for short. They work to stop infection of HIV into cells, but have different chemical structures than the nucleoside reverse transcriptase inhibitors, like AZT, d4T, ddC, ddI and 3TC.

Both types of drugs work during the early part of viral infection of a cell, to stop it from taking over the cell. The nucleoside type of drugs work by taking the place of normal building blocks to stop the virus from inserting its genetic code into that of the cell. The NNRTIs work directly on the enzyme reverse transcriptase, in order to stop it from working correctly, which also stops the virus from genetic takeover of the cell. Protease inhibitors work later in the virus cycle. After HIV has taken over a cell, and is trying to make more copies of itself, protease inhibitors block a step in the process so that no new viruses can be sent out to the rest of the body.

Research has shown that the best way to use anti-HIV drugs is by taking them in combination, with more than one type of drug at a time. This is because when you are using different types of drugs, you are able to stop the virus at different steps of its life cycle, kind of like an assembly line, where there are several chances to stop the production along the way. By keeping HIV from making copies of itself (replicating), a person’s viral load should be lower, their T cells should be stable or go up, and there should be less chance of HIV becoming resistant to the drugs.

About This Study. The study we are doing compares three treatment regimens. Everyone who is in this study will be randomly assigned to one of three groups (also known as "arms" of the study):

DMP 266 + indinavir (Crixivan®)
OR
DMP 266 + AZT + 3TC
OR
indinavir + AZT + 3TC

One good thing about the DMP 266 is that you only have to take it once a day. (The other drugs need to be taken more often). Everyone will know what drugs they are taking, and everyone will get real drugs -- there are no fake (placebo) pills being used in this study.

DMP 266 has been studied in the test tube, in animals, and in people. It has been shown to be safe and to work well against HIV in combination with indinavir. In one small study with 30 people, 85% of the people (13 out of 15) had undetectable viral load after taking DMP 266 and indinavir together for 42 weeks. Also, there was an average increase in CD4 of about 140 T-cells for the people taking this combination. DMP 266 also appears to work well in combination with AZT and 3TC (with no protease inhibitor) to lower viral load. Results from a recent study compare different dosing levels of DMP 266 in 137 people. After 16 weeks In this study, 88% of the 25 people taking DMP 266 at 600 mg once a day in combination with AZT and 3TC had viral load below 400 copies/mL, with an average increase in CD4 cell count of 157.

The most common side effects that people have had while taking DMP 266 have been mild skin rash and feelings of lightheadedness and dizziness. These side effects have usually gone away within a couple of days or weeks. People are being asked to take the DMP 266 before going to sleep, so that the possible dizziness and feeling "drugged" can happen then, rather than when they’re trying to stay awake.

In order to be in this study, a person must meet some basic requirements:

There are some other requirements, which research staff will go over with people who are interested in taking part.

This study will last at least 60 weeks, with a few study visits before starting the drug, and then once a month after the first two weeks of the study. CDN is now offering this study at: Newark Community Health Centers (New Jersey) Sunset Terrace Family Health Center (Brooklyn) Gouverneur -- Leicht Clinic (Lower East Side, Manhattan) CFPC Lower East Side Center (Manhattan) CFPC United Parents Center (East New York, Brooklyn)

The study may be offered at more health centers in the CDN network in the future.

If you are interested in finding out more, please speak to your health care provider and call Cori Blum at 212/255-3841, ext. 37.

CPCRA Acupuncture Study Results

Results from the CPCRA 022 Acupuncture Protocol were released last month. This study was one of few large randomized clinical trials that have formally tested an "alternative" regimen for HIV-related compli-cations. The goal was to test a standardized acupuncture regimen and a drug called amitriptyline (also known as Elavil) for relieving pain caused by HIV-related peripheral neuropathy. Peripheral neuropathy is a condition where people experience pain from nerve damage, usually in their feet and hands. A total of 250 patients were enrolled in this study around the country, with CDN enrolling a total of 26 participants at St. Vincent’s Hospital and Newark Community Health Center.

The study showed that there were no significant differences in pain relief from either the acupuncture or the amytriptyline. There was also no difference in serious side effects nor in death rates. It is important to note that although the acupuncture in the study did not give relief, there are other acupuncture methods which seem to work very well to relieve pain. Acupuncture involves evaluation of the patient at each visit, which tells the provider which points should be used at that time. The study made people use the same needle points every time, which isn’t how acupuncturists usually work. So, this study does not show that acupuncture doesn’t work, but it does show that this particular way of using it is ineffective.

The study results should help providers and people living with pain in their decisions about treatment options, by showing that amitriptyline is not an effective therapy for peripheral neuropathy.

Upcoming Events & Resources

New Treatments for HIV - Protease Inhibitors Update. November 13, 9:30 am-12:00 pm at the Lower Manhattan AIDS Task Force, with Richard Jefferys from the AIDS Treatment Data Network. Call Karen at 212/645-0875, ext. 112, for more information.

HIV Treatment: Making Sense, Making Choices. November 17 & 18, 6:30-8 pm at GMHC. Learn about HIV, the immune system, anti-viral therapies, and treatment decisions. Call Wendee Rogerson at 212/367-1458 to register.

DAAIR - Direct AIDS Alternative Information Resources is a non-profit organization that sells complementary therapies (vitamins, minerals, amino acids, herbs, and other supplements) to people living with HIV. They also have a free booklet called the Membership Outreach Pack that has information about complementary therapies and wellness. Call 212/725-6994 to order the booklet and find out more about these resources.

Medicaid Managed Care Education Project offers free workshops for Medicaid recipients to understand how to access health care under mandatory Medicaid managed care. To schedule a workshop, please call Awilda Martinez at 212/614-5337.

Women’s Education Services at GMHC offers1 support groups, acupuncture, information and referrals. Call 212/367-1363 for more information.

Nutrition Workshop

"What you eat is critical for how you function," stated Edwin Krales of the Momentum AIDS Project at the Manhattan CAB Workshop held at CDN in July. This is especially true for people who are HIV-positive to help maintain health and energy since malnutrition, meaning that you do not get the daily minimum requirement of nutrients from your diet, can eventually cause further immune deficiency. Eating well is also important because "medication[s] ...you take work...better in a well nourished body."

What does "eating well" mean? You should have on a daily basis: from the bread, cereal, rice, pasta group 6-11 servings; from the vegetable group 3-5 servings; from the fruit group 2-4 servings; from the milk, yogurt & cheese group 2-3 servings; from the meat, poultry, fish, dry beans, eggs, & nuts group 2-3 servings; and a very limited amount from the fats, oils & sweets group.

What is a serving?

Water is very important to flush the kidneys and urinary tract, especially when taking certain medications. For example, Mr. Krales suggests that you drink one cup of water every hour if you are taking a drug like Crixivan. Coffee, tea, cola and alcohol should not be used instead of water because they are diuretics, meaning they cause more frequent urination. It is also important to remember that some water sources contain bacteria and chemicals which can be toxic to your system; it is best to drink bottled water from a company that is known for selling good clean water.

Nutritious food is the best source of calories because it also provides you with many vitamins and minerals essential to the body’s function. The reason why vitamin supplements should not replace nutritious food as your main source of vitamins is that, as Edwin Krales points out, "you can only put in a pill what you know exists." Scientists and nutritionists are always finding new uses for nutrients in your body and often debate how much of each is necessary to maintain optimal health. If you eat nutritious food "your body knows...[and] will take out of [food] what it needs."

Protein helps to give you energy and build muscle in your body so it is an important part of your daily diet. While protein is important it is better to get your protein from vegetables, beans and eggs so that you don’t overeat protein. Protein from meat may also carry growth hormones fed to animals.

Toxoplasmosis and salmonella can be caused by undercooked meat and salmonella can come from under-cooked eggs. Eggs must be well cooked, not runny. Meat must be cooked at or above 185 degrees and until the juices run clear, then kept hot or stored in extreme cold. Remember that bacteria thrive between 40 and 140 degrees.

There are many programs which help people with HIV eat properly by providing pantry programs, meal delivery, and meal planning programs.

SMART/EST Study

The SMART/EST Women’s Project is a study being offered by the Clinical Directors Network at several community health centers in New York City and New Jersey. The program is looking at ways for women with AIDS to manage and reduce stress. Participants are randomly assigned to either an individual or group intervention, which they attend once a week for ten weeks, and then receive monthly maintenance sessions and scheduled follow-up visits for a little over a year. Participants are reimbursed for their time.

Currently, there are seven sites where the SMART/EST study is being offered: Newark Community Health Center-Ludlow Street; Eric B. Chandler Community Health Center, New Brunswick, NJ; Jersey City Family Health Center; Morris Heights Health Center, Bronx; Community Research Initiative on AIDS (CRIA), Manhattan; Betances Health Unit, Lower East Side Manhattan; and Community Family Planning Council (CFPC) multiple sites in New York City. A total of 50 women have been enrolled so far from these sites.

To be a part of this study, women must have a diagnosis of AIDS from their health care provider. Women can come from any part of the metropolitan area, but must be willing to attend the sessions at the site where they join the study. The women who are assigned to the group condition participate in a stress management program that meets once a week for two hours for 10 weeks. The women in the individual sessions come to the health center once a week for 10 weeks to watch video tapes on stress management and HIV/AIDS.

If you are interested in finding out how you can be a part of the SMART/EST Women’s Project, you can call Anna Sanchez (Coordinator for the Bronx, Jersey City, CFPC, and Betances ) at 212/255-3841, ext. 21, or Yolene Gousse (Coordinator for New Brunswick, Newark, and CRIA) at 212/255-3841, ext. 22.

Thanks to the women who are currently in the SMART/EST Women’s Project for their commitment and continued support.

Children & HIV/AIDS

The Children with HIV/AIDS booklet informs children about HIV and AIDS. It contains three sections: questions and answers, fun activities, and a convenient list of services for children. This book lets the child learn more about the disease they have, how to live with it, and how to build self-confidence. This booklet was developed by Samantha Ferdinand-Davis, an intern for the HIV/AIDS Program this summer. If you would like a free copy, please write to: Vicki Rosenwald Clinical Directors Network 8 West 19 Street, 8th Floor New York, NY 10011, or call Vicki at 212/255-3841, ext. 30 (phone); 212/255-5227 (fax).

CAB Meetings

The four Community Advisory Boards (CABs) in the Clinical Directors Network (Manhattan, Bronx, Brooklyn, and Newark) are made up of people with HIV and their care providers. CABs meet every two months to discuss new developments in HIV/AIDS, to hold community education events, and to advise CDN about its AIDS clinical research program. New members are welcome at each CAB meeting. Transportation costs and refreshments are provided. If you would like more information about the CAB meetings and workshops, contact Cori Blum at 212-255-3841, ext. 37.

Goodbye and Congratulations

CDN’s HIV/AIDS Program send best wishes to Lisa Anne Harewood, who left our program in early October to go to work at Cornell Medical Center’s Clinical Trials Unit. Lisa started here as an intern more than 2 years ago, and worked as our Research Assistant for the past year and a half. Lisa made many valuable contributions to the development of our clinical trials program, and coordinated the Manhattan CAB for the past 6 months. We miss Lisa very much, and know that she will excel in her new position.

Past-due congratulations to Stephen Long for graduating from the AIDS Service Center’s Peer Recovery Education Program in August. Stephen will surely use his training to continue doing outreach and education about HIV and recovery issues, as well as maintaining his position as the Manhattan CAB Chair.

The CAB Update is published by the Clinical Directors Network, Inc. (CDN), and is distributed at no charge to the members of its Community Advisory Boards.

Articles, topics for articles, or comments about the information presented are welcome. Please direct all comments and materials to Cori Blum, CDN, 8 West 19 St., 8th Floor, NY, NY, 10011; (212) 255-3841 ext. 37

CDN is dedicated to improving comprehensive and accessible community-oriented primary and preventive health care services and research opportunities for underserved populations and the clinicians who serve them.

Jonathan N. Tobin, Ph.D., Executive Director
Ramon A. (Gabriel) Torres, M.D., Medical Director
Anita Vaughn, MD, Co-Principal Investigator
Conrad Fischer, MD, Principal Investigator

CDN HIV/AIDS Program Staff:
Vicki Rosenwald, RN, MPH, HIV Research Manager
Cori Blum, HIV Clinical Research Associate, Editor
Lisa Harewood, HIV Clinical Research Assistant
Samantha Ferdinand-Davis, HIV/AIDS Program Intern
Kimberly Boer, HIV/AIDS Program Intern



CDN HIV/AIDS Program

Last modified 11/1/97
Clinical Directors Network
copyright © 1997 CDN

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