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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000854
• Other study ID #: ACTG 329
• Secondary ID: 11301
• Status: Completed
• Phase: Phase 1
• Est. completion date: May 2003

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cachexia
• HIV Infections
• HIV Wasting Syndrome
• Syndrome
• Weight Loss

Intervention

Drug:
• Nandrolone decanoate

Locations

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

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & 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. — View Citation