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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000854 |
Purpose
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.
| Condition | Intervention | Phase |
|
HIV Infections HIV Wasting Syndrome |
Drug: Nandrolone decanoate |
Phase I |
| MedlinePlus related topics: | AIDS Weight Control |
| Drug Information available for: | Nandrolone Nandrolone decanoate Nandrolone phenpropionate |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss |
| Estimated Enrollment: | 38 |
| Study Start Date: | December 1996 |
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.
Eligibility
| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
Contacts and Locations![]() |
Show 21 Study Locations |
| Study Chair: | K Mulligan | |
| Study Chair: | R Clark | |
| Study Chair: | J Currier |
More Information
|
Mulligan K, Zackin R, Clark RA, Sattler FR, Santana J, Delvers T, Currier JS. Nandrolone decanoate increases weight and lean body mass in HIV-infected women with weight loss: a randomized, double-blind, placebo-controlled, multicenter trial. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 641)
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| Study ID Numbers: | ACTG 329 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000854 |
| Health Authority: | United States: Federal Government |
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