A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss

Completed · Phase 1

Conditions studied: HIV Infections, HIV Wasting Syndrome

In brief

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.

Key facts

Study ID

NCT00000854

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

38

Expected to finish

2003-05-01

Last updated by the study team

2021-10-29

Who can join

Age: 13 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• USC CRS — Los Angeles, California, United States
• UCLA CARE Center CRS — Los Angeles, California, United States
• Ucsd, Avrc Crs — San Diego, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Howard University Hosp., Div. of Infectious Diseases, ACTU — Washington D.C., District of Columbia, United States
• Queens Med. Ctr. — Honolulu, Hawaii, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU — New Orleans, Louisiana, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
• Washington U CRS — St Louis, Missouri, United States
• St. Louis ConnectCare, Infectious Diseases Clinic — St Louis, Missouri, United States
• Beth Israel Med. Ctr. (Mt. Sinai) — New York, New York, United States
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• Duke Univ. Med. Ctr. Adult CRS — Durham, North Carolina, United States
• Univ. of Cincinnati CRS — Cincinnati, Ohio, United States
• Hosp. of the Univ. of Pennsylvania CRS — Philadelphia, Pennsylvania, United States
• Puerto Rico-AIDS CRS — San Juan, Puerto Rico
• San Juan City Hosp. PR NICHD CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.