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.

We 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 adminstered dose will be 300 micrograms twice a week vs. 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 microgams twice a week will be initated for 12 months in all subjects following the randomized portion of the study.

Ages Eligible for Study:  18 Years   -   50 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

• Female (age 18-50)
• HIV-infected
• Androgen deficient, with free testosterone < 3 pg/mL
• Weight < 90% Ideal Body Weight (IBW) or weight loss > 10% or weight loss > 5% over prior 6 months
• Stable antiretroviral regimen for 3 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.

Exclusion Criteria:

• Use of anabolic agent, including testosterone, growth hormone (GH) or other preparations within 3 months of the study.
• Use of megestrol acetate within 3 months of the study
• Use of estrogen or any preparation known to affect bone density or bone turnover. This includes oral contraceptives, depo provera or combined progesterone-estrogen injections, and transdermal contraceptive patches.
• Pregnant or breast-feeding
• Hgb < 9.0 mg/dL
• Current participation in another research study conducted by this investigator or past participation in the DHEA study funded by the same grant as this protocol.
• Creatinine > 1.5 mg/dL
• 25-OHD level < the normal range
• Calcium level > the normal range
• FSH level > 25 mIU/ml (if amenorrheic)
• History of congested heart failure, unstable angina, deep vein thrombosis, breast cancer, or sleep apnea.