Androgen Effects in HIV-infected Women
Completed · Not applicable · Has a placebo group
Conditions studied: HIV Infection
In brief
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.
Key facts
- Study ID
- NCT00095212
- Run by
- Massachusetts General Hospital
- People needed
- 25
- Starts
- 2004-09-01
- Expected to finish
- 2009-02-01
- Last updated by the study team
- 2010-04-14
Who can join
Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Mass General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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