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

Primary Purpose

HIV Infections, HIV Wasting Syndrome

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Nandrolone decanoate
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Placebos, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Anabolic Steroids, HIV Wasting Syndrome, nandrolone decanoate

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • USC CRS
  • UCLA CARE Center CRS
  • Ucsd, Avrc Crs
  • Ucsf Aids Crs
  • University of Colorado Hospital CRS
  • Howard University Hosp., Div. of Infectious Diseases, ACTU
  • Queens Med. Ctr.
  • Univ. of Hawaii at Manoa, Leahi Hosp.
  • Northwestern University CRS
  • Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
  • Johns Hopkins Adult AIDS CRS
  • Beth Israel Deaconess Med. Ctr., ACTG CRS
  • Washington U CRS
  • St. Louis ConnectCare, Infectious Diseases Clinic
  • Beth Israel Med. Ctr. (Mt. Sinai)
  • Univ. of Rochester ACTG CRS
  • Unc Aids Crs
  • Duke Univ. Med. Ctr. Adult CRS
  • Univ. of Cincinnati CRS
  • Hosp. of the Univ. of Pennsylvania CRS
  • Puerto Rico-AIDS CRS
  • San Juan City Hosp. PR NICHD CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000854
Brief Title
A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV Wasting Syndrome
Keywords
Placebos, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Anabolic Steroids, HIV Wasting Syndrome, nandrolone decanoate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Enrollment
38 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nandrolone decanoate

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K Mulligan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
R Clark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
J Currier
Official's Role
Study Chair
Facility Information:
Facility Name
USC CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA CARE Center CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035
Country
United States
Facility Name
Ucsd, Avrc Crs
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Ucsf Aids Crs
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
University of Colorado Hospital CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Howard University Hosp., Div. of Infectious Diseases, ACTU
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Queens Med. Ctr.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Univ. of Hawaii at Manoa, Leahi Hosp.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Adult AIDS CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Beth Israel Deaconess Med. Ctr., ACTG CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Louis ConnectCare, Infectious Diseases Clinic
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
Facility Name
Beth Israel Med. Ctr. (Mt. Sinai)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Univ. of Rochester ACTG CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Unc Aids Crs
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke Univ. Med. Ctr. Adult CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Univ. of Cincinnati CRS
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Hosp. of the Univ. of Pennsylvania CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Puerto Rico-AIDS CRS
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
15767536
Citation
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. doi: 10.1001/archinte.165.5.578.
Results Reference
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A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss

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