clinical trials listings from the AIDS Treatment Data Network

Trials for the treatment of wasting

Contact numbers on these pages are for the New York area. Many of the trials are nationwide. For sites in your area, call the AIDS Clinical Trials Information Services (ACTIS) at 1-800-TRIALS-A.

ACTG 329. Drug: nandrolone decanoate. This trial will study nandrolone decanoate for the treatment of weight loss associated with HIV infection in women. Participants will be divided into two groups. One group will receive nandrolone decanoate. The second group will receive a placebo. Both the nandrolone decanoate and placebo will be given by intramuscular injection (a shot into the muscle) every two weeks. Neither the doctor nor the participant will know which treatment is being given. Participants who are taking antiretroviral therapy will continue. All participants who successfully complete the first 12 weeks of the study will be eligible to receive open-label nandrolone decanoate for a further 12 weeks. To participate you must be an HIV+ woman with involuntary weight loss of greater than 5% of your body weight or BMI (body mass index) < 20 kg/m² within the past 12 months. If starting antiretroviral therapy, you must wait 30 days before enrolling in trial. If taking DHEA, you must be on a stable dose for at least 30 days before enrolling. Oral supplements are allowed. You cannot be pregnant or nursing. The study coordinator will go over with you drugs not allowed while on study. Contact: Carsandra Diggs, PA-C, Beth Israel Medical Center, New York, NY, (212) 420-4519, Eileen Donaghy, RN, University of Pennsylvania Medical Center, Philadelphia, PA, (215) 349-8092. (updated 10/16/97)

ACTG 392. Treatment: Optimune. Participants will receive either a nutritional supplement that contains whey protein or a supplement that does not contain the whey protein. Each packet of the nutritional supplements used in this study will contain 40 grams of high quality protein. Everyone in the study will take two protein packets a day, one between breakfast and lunch, one between lunch and dinner. Total time on treatment: 12 weeks. Required: HIV+, male or female, > 3% body weight loss since HIV diagnosis. Not allowed: diabetes, no nutritional or health food supplements are allowed except for a daily multivitamin. Contact: Valerie Hughes, NP, Cornell Medical Center, New York NY, (212) 746-4393. (added 8/18/99)

GIM 01. Drug: Serostim. This trial will study how effective Serostim (human growth hormone) is for the treatment of HIV related wasting. Patients must be on at least two antiretrovirals and not switch switch therapy while in study. Antiretroviral therapy may or may not include a protease inhibitor. Total time on drug: 6 months. Required: HIV+, age: >18 yrs, male or female, stable anti-HIV treatment for at least eight weeks, weigh less than 95% of ideal body weight, life expectancy of at least 3 months. Not allowed: pregnant women and nursing mothers, carpal tunnel syndrome, diabetes mellitus, any disorder associated with moderate to severe edema, active opportunistic infection needing acute treatment, any active cancer except skin KS with <10 lesions, chronic diarrhea, unstable hypertension, Glucose intolerance, persistent fever during past 30 days. Not allowed: evidence of GI bleeding, obstruction or malabsorption. Drugs not allowed: new therapy for wasting, including parenteral or oral hyperalimentation, testosterone , anabolic or progestational agents in past 30 days, radiation or chemotherapy in past 12 months, new systemic therapy for OI's in past 30 days. Contact: Tricia Driscoll, RN, Children's Medical Center of Brooklyn, Brooklyn NY, (718) 270-44872870. (added 8/18/99)

Serono 9037. Drug: Serostim. This trial will study Serostim, a recombinant human growth hormone, for the treatment of wasting associated with HIV infection. Participants will be divided into three groups. The first group will be treated with full dose Serostim for 12 weeks. The second group will be treated with half dose Serostim for 12 weeks. The third group will be treated with placebo for 12 weeks. Then everyone will be divided into two groups. One group will be treated with half dose Serostim and the other group will be treated with full dose Serostim. Treatment is by shot. Neither the doctor nor the participant will know which dose or treatment is being given. To participate you must be HIV+ and 18 year or older with unintentional weight loss of more than 10%. You cannot be pregnant or nursing. Total time on study is 12 weeks. Contact: Laurie Andrews, RN, Yale University Medical Center, New Haven, CT, (203) 785-3557. (modified 10/16/97)

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Last modified: 8/18/99 The Network copyright © 1999 The Network