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

Phase 1

Completed

• Conditions: HIV Infections; HIV Wasting Syndrome

• Registration Number: NCT00000854
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

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.

Study Timeline

• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Study Completion: 2003-05
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (22)

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, 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

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