A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
Nandrolone decanoate
Blood-Borne Infections+19
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.38 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
UCLA CARE Center CRS
Los Angeles, United StatesUcsd, Avrc Crs
San Diego, United StatesUcsf Aids Crs
San Francisco, United States