Completed

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

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What is being tested

Nandrolone decanoate

Drug
Who is being recruted

HIV Infections

+ HIV Wasting Syndrome
Over 13 Years
How is the trial designed

Treatment Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 29, 2021
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleA Randomized, Double-Blind, Placebo-Controlled, Phase I/II Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 29, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
38 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
HIV Wasting Syndrome
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 22 locations
Suspended
USC CRSLos Angeles, United StatesSee the location
Suspended
UCLA CARE Center CRSLos Angeles, United States
Suspended
Ucsd, Avrc CrsSan Diego, United States
Suspended
Ucsf Aids CrsSan Francisco, United States

Completed22 Study Centers