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

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • San Juan City Hosp. PR NICHD CRS
      • San Juan, Puerto Rico, 00935
        • Puerto Rico-AIDS CRS
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC CRS
      • Los Angeles, California, United States, 90035
        • UCLA CARE Center CRS
      • San Diego, California, United States, 92103
        • Ucsd, Avrc Crs
      • San Francisco, California, United States, 94110
        • Ucsf Aids Crs
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital CRS
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard University Hosp., Div. of Infectious Diseases, ACTU
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Queens Med. Ctr.
      • Honolulu, Hawaii, United States, 96816
        • Univ. of Hawaii at Manoa, Leahi Hosp.
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University CRS
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Adult AIDS CRS
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Med. Ctr., ACTG CRS
    • Missouri
      • Saint Louis, Missouri, United States, 63112
        • St. Louis ConnectCare, Infectious Diseases Clinic
      • Saint Louis, Missouri, United States, 63110
        • Washington U CRS
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Med. Ctr. (Mt. Sinai)
      • Rochester, New York, United States, 14642
        • Univ. of Rochester ACTG CRS
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Unc Aids Crs
      • Durham, North Carolina, United States, 27710
        • Duke Univ. Med. Ctr. Adult CRS
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Univ. of Cincinnati CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hosp. of the Univ. of Pennsylvania CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: K Mulligan
  • Study Chair: R Clark
  • Study Chair: J Currier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 329
  • 11301 (Registry Identifier: DAIDS ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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