Androgen Effects in HIV-infected Women

Mass General Brigham

Status

Completed

Conditions

HIV Infection

Treatments

Drug: 1 Transdermal Testosterone (Patch)

Drug: 2 Placebo Patch

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00095212

R01DK054167 (U.S. NIH Grant/Contract)

DK54167 (completed)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

25 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female 18 - 55
BMI less than or equal to 26
HIV-infected
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.

Exclusion criteria

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