Status:
COMPLETED
Androgen Effects in HIV-infected Women
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
HIV Infection
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief 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...
Detailed 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 bod...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00095212
Start Date
September 1 2004
End Date
February 1 2009
Last Update
April 14 2010
Active Locations (1)
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1
Mass General Hospital
Boston, Massachusetts, United States, 02114