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The following studies are currently recruiting patients. Find more study information online.
Androgen Effects in HIV-Infected Women
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Purpose: Androgen deficiency in HIV-infected women is associated with sarcopenia and may cause critical reductions in physical functioning and reduced bone density. The effects of long-term androgen therapy on lean body mass, bone density and other clinical endpoints including quality of life, functional status and neurocognitive function in HIV-infected women are not known.
Condition:
Wasting Syndrome
Drug Treatment:
Testosterone
Study Type: Interventional
Study Design:
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment,
Efficacy Study
Study Details:
* Expected Total Enrollment-
60
* Study start- September
2004
* Outcomes- Primary:
lean body mass; Secondary: strength, bone density, quality of life, neurocognitive
function, safety
Investigators will perform an 18-month randomized, double-blinded, placebo-controlled study among relatively androgen deficient women with AIDS wasting, to determine the effects of testosterone administration on lean body mass. The administered dose will be 300 micrograms twice a week versus identical placebo in the form of a transdermal preparation. Secondary endpoints include effects on bone density, quality of life, neurocognitive function and menstrual function. Open label administration at 300 micrograms twice a week will be initiated for 12 months in all subjects following the randomized portion of the study.
* Eligibility Criteria- HIV-positive female (age 18-50)
* Inclusion Criteria-
- Androgen deficient, with testosterone less than 30 ng/dL
- Weight less than 90% ideal body weight (IBW) or weight loss more than 10% or greater than 5% over prior six months
- Stable antiretroviral regimen for three months prior to study
- Tubal ligation, hysterectomy, or verbalized understanding of appropriate barrier contraception methods. Subjects will be counseled in appropriate barrier contraception methods and the counseling will be documented.
