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 HIV, to determine the effects of testosterone
administration on lean body mass. The administered 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 micrograms twice a week will be initiated for 12 months in
all subjects following the randomized portion of the study. Assuming a 15% dropout rate and
25 randomized patients, the probability is 80 percent that the study will detect a treatment
difference at a two sided 5.000 percent significance level, if the true difference between
the treatments is 2.7 kg. This is based on the assumption that the standard deviation of the
response variable, lean body mass by DEXA, is 2.3 kg, as was shown by Choi et al1 over 12
weeks in HIV-infected women at the same dose of 300 ug 2x/week.
- Female 18 - 55
- BMI less than or equal to 26
- Androgen deficient, with free testosterone < 3 pg/mL
- 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.
- Use of anabolic agent, including testosterone, 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