Official Title: “A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss”

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.

Study Type: Interventional

Study Design: Treatment, Parallel Assignment, Safety Study

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.

Intervention(s) in this Clinical Trial

• Drug: Nandrolone decanoate

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Overall Clinical Trial Officials and Contacts

K Mulligan Study Chair   

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00000854

Study ID Number: ACTG 329

ClinicalTrials.gov Identifier: NCT00000854

Health Authority: United States: Federal Government