A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
2 other identifiers
interventional
38
2 countries
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedOctober 29, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
USC CRS
Los Angeles, California, 90033, United States
UCLA CARE Center CRS
Los Angeles, California, 90035, United States
Ucsd, Avrc Crs
San Diego, California, 92103, United States
Ucsf Aids Crs
San Francisco, California, 94110, United States
University of Colorado Hospital CRS
Aurora, Colorado, 80045, United States
Howard University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., District of Columbia, 20060, United States
Queens Med. Ctr.
Honolulu, Hawaii, 96813, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, 70112, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215, United States
Washington U CRS
St Louis, Missouri, 63110, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10003, United States
Univ. of Rochester ACTG CRS
Rochester, New York, 14642, United States
Unc Aids Crs
Chapel Hill, North Carolina, 27514, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, 27710, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104, United States
Puerto Rico-AIDS CRS
San Juan, 00935, Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, 00936, Puerto Rico
Related Publications (1)
Mulligan K, Zackin R, Clark RA, Alston-Smith B, Liu T, Sattler FR, Delvers TB, Currier JS; AIDS Clinical Trials Group 329 Study Team; National Institute of Allergy and Infectious Diseases Adult AIDS Clinical Trials Group. Effect of nandrolone decanoate therapy on weight and lean body mass in HIV-infected women with weight loss: a randomized, double-blind, placebo-controlled, multicenter trial. Arch Intern Med. 2005 Mar 14;165(5):578-85. doi: 10.1001/archinte.165.5.578.
PMID: 15767536BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
K Mulligan
- STUDY CHAIR
R Clark
- STUDY CHAIR
J Currier
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
May 1, 2003
Last Updated
October 29, 2021
Record last verified: 2021-10