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

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00000854
Collaborator
(none)
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22
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nandrolone decanoate
Phase 1

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 Design

Study Type:
Interventional
Intervention Model:
Parallel Assignment
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
Actual Study Completion Date :
May 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT00000854
    Other Study ID Numbers:
    • ACTG 329
    • 11301
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Oct 29, 2021
    Last Verified:
    Oct 1, 2021

    Study Results

    No Results Posted as of Oct 29, 2021