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CRIA Trials Now Enrolling

Fall 1998

Fat Accumulation in the Belly (FAB) Study
Fat buildup in the abdomen may be a complication of protease inhibitor use. CRIA is studying the safety of daily human growth hormone injections as a possible treatment for this complication. To be eligible for this 24-week study, you must be HIV-infected, on stable antiretroviral therapy, and have noticed increasing abdominal size.

Oxandrolone for Women with Weight Loss
Oxandrolone is BTG's anabolic steroid hormone which has shown promise as a treatment for AIDS-related wasting in small, preliminary studies and, unlike testosterone, can be taken as a pill. CRIA is participating in a multicenter study of oxandrolone for AIDS-related wasting in women. In this study, different doses of oxandrolone will be compared with inactive pills (placebo) for 12 weeks, followed by a 24 week period during which all participants will receive oxandrolone. Participants must be HIV-positive with unintentional weight loss of 10-20% of their usual body weight. Participants will be reimbursed $15 per scheduled study visit after enrollment.

Protease Inhibitor and Blood Sugar Study
CRIA is conducting a study to examine the effects of protease inhibitor use on responses to the oral glucose tolerance test (measurement of blood sugar levels after taking a drink with a high sugar content). To be eligible, participants must be about to start treatment with a protease inhibitor drug for the first time. Participants will be reimbursed $30 for each of the first two visits and $50 for the final visit.

SMART/EST Women's Project
CRIA is participating in a multicenter study to test a 10-week stress management program to teach women how to cope more effectively with their illness and everyday problems. Two approaches -- individual and group relaxation training -- are being compared. Women 18 years of age and older with a diagnosis of AIDS may be eligible. Participants will be reimbursed $25 per visit after enrollment (up to $575). Free child care and refreshments will be provided. For more information, call Debra Munger at 212-924-3934.

Testosterone and MET-Rx™
CRIA is sponsoring a study of testosterone and MET-Rx™, a high protein nutritional supplement for treatment of AIDS-related wasting. Participants will receive testosterone or placebo injections in combination with MET-Rx™ or standard nutritional supplement. Participants must be HIV-positive men with T-cell counts of less that 400, low testosterone levels, and weight loss or loss of lean body mass. For information, call Dr. Judith Rabkin at 212-543-5762.

SALSA™ Questionnaire for Lipodystrophy
CRIA is participating in a multicenter information-gathering study sponsored by Serono Laboratories with the goal of better defining the features of lipodystrophy syndrome. Persons who think they have features of the syndrome, which include thinning of the arms and legs, fat redistribution to the abdomen, and buffalo hump are encouraged to schedule a one-time visit to complete the questionnaire. Eligible participants will be reimbursed $10 for their time.


For more information on any of these studies, please call Dr. Avinash Desai or Dr. Douglas Mendez at (212) 924-3934, or visit our Web site (www.aidsinfonyc.org/cria).


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