Overview

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

Status:
Completed
Trial end date:
2003-05-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Decanoic acid
Nandrolone
Nandrolone Decanoate
Nandrolone phenpropionate
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.