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.

Page 1 of 6 (22 locations)

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