Status:
COMPLETED
A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
HIV Wasting Syndrome
Eligibility:
FEMALE
13+ years
Phase:
PHASE1
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 ...
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, d...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
May 1 2003
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00000854
End Date
May 1 2003
Last Update
October 29 2021
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
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