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Home > "A" Clinical Trials Conditions > A Study to Evaluate the Effect of Nandrolone Decanoate in Women with HIV-Associated Weight Loss  A Study to Evaluate the Effect of Nandrolone Decanoate in Women with HIV-Associated Weight Loss
A Study to Evaluate the Effect of Nandrolone Decanoate in Women with HIV-Associated Weight Loss
For Condition: HIV Infections,HIV Wasting Syndrome
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to see if giving nandrolone decanoate (a hormonal drug) will cause weight gain in HIV-positive women who have HIV-associated weight loss (wasting). Wasting has become an AIDS-defining condition. In the past, most studies that examined wasting treatments were limited to men. However, it appears that wasting in HIV-positive men is linked to levels of testosterone (a hormone which affects men's bodies more than women's). This study has been designed for women only, in order to best treat wasting in HIV-positive women.
Details: Body wasting is an increasingly frequent AIDS-defining condition and it is becoming evident that women are not exempt from this complication of HIV. Although multicenter trials of megestrol acetate, dronabinol and growth hormone have not specifically excluded women, women have generally been underrepresented in these trials. This study hopes to generate data that will be substantial enough to perform an analysis that might determine whether there are gender-based differences in anabolic potential. Patients will be randomized to receive either nandrolone decanoate or placebo every 2 weeks for 12 weeks of the study. All patients who complete the first 12 weeks of the study will be eligible to receive open-label nandrolone for the subsequent 12 weeks.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Female
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are an HIV-positive woman over 13 years old (need consent if under 18). - Have lost weight over the past 12 months. - Are able to eat almost enough to maintain your current weight. - Agree to practice abstinence or use effective methods of birth control. - Are on a stable anti-HIV drug regimen or have not been on any anti-HIV drug regimen for the past 30 days. Exclusion Criteria You will not be eligible for this study if you: - Are allergic to nandrolone. - Have a history of cervical cancer, diabetes, cardiomyopathy or congestive heart failure, or are taking certain medications. - Have an active opportunistic (HIV-associated) infection or another major illness within 30 days of study entry. - Have an abnormal PAP smear. - Have difficulty eating (are on tube-feeding, for example). - Have severe nausea, vomiting, or diarrhea. - Have Kaposi's sarcoma (unless stable) or are receiving chemotherapy or radiation for any type of cancer. - Are pregnant or breast-feeding.
Total Enrollment: 38
Location and Contact Information:
Overall Study Official:
KMulligan, Study Chair,
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Additional Information:
Study ID Numbers: ACTG 329;
Study Start Date: December 1996
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000854
Other Hiv Wasting Syndrome Studies:
1. A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome
2. A Study to Evaluate the Effect of Nandrolone Decanoate in Women with HIV-Associated Weight Loss
3. A Study of Megestrol Acetate Alone or in Combination with Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss
4. Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
5. Growth Hormone in the Treatment of HIV-Associated Wasting
Related Studies:
Other HIV Wasting Syndrome Clinical Trials
Other Louisiana Clinical Trials
Other New Orleans Clinical Trials
A Study to Evaluate the Effect of Nandrolone Decanoate in Women with HIV-Associated Weight Loss
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