Androgen Effects in HIV-infected Women

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Androgens; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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