A Phase 1 interventional study of Nandrolone decanoate in HIV Infections and HIV Wasting Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 22 sites in 2 countries. Open to female participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2021-10-29.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment
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.
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.
196 studies on the registry are indexed under Wasting Syndrome; 22 are open to participants now.
This study's enrollment of 38 is below the median of 58 across 130 interventional studies indexed under Wasting Syndrome.
Browse Wasting Syndrome studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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HIV Wasting Syndrome
National Institute of Allergy and Infectious Diseases (NIAID)