NCT00000854

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (planned)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: Female
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• HIV Infections
• HIV Wasting Syndrome

Interventions

Type	Name	Description
DRUG	Nandrolone decanoate

Timeline

• Completion: 2003-05-01
• First posted: 2001-08-31
• Last updated: 2021-10-29

Locations

22 sites across 2 countries: United States, Puerto Rico