Androgen Effects in HIV-infected Women

NCT ID: NCT00095212

Last Updated: 2010-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2009-02-28

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 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.

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 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.

Conditions

HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1 Transdermal Testosterone (Patch)

300 micrograms applied twice a week

Group Type: ACTIVE_COMPARATOR

1 Transdermal Testosterone (Patch)

Intervention Type: DRUG

300 micrograms twice a week

2 Placebo Patch (identical in appearance)

placebo patch (0 micrograms of testosterone)applied twice a week

Group Type: PLACEBO_COMPARATOR

2 Placebo Patch

Intervention Type: DRUG

Placebo patch (0 micrograms of testosterone) applied twice a week

Interventions

1 Transdermal Testosterone (Patch)

300 micrograms twice a week

Intervention Type: DRUG

2 Placebo Patch

Placebo patch (0 micrograms of testosterone) applied twice a week

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

MGH

Locations

Mass General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Dolan Looby SE, Collins M, Lee H, Grinspoon S. Effects of long-term testosterone administration in HIV-infected women: a randomized, placebo-controlled trial. AIDS. 2009 May 15;23(8):951-9. doi: 10.1097/QAD.0b013e3283299145.

Reference Type: RESULT

PMID: 19287303 (View on PubMed)

Other Identifiers

R01DK054167

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK54167 (completed)

Identifier Type: -

Identifier Source: org_study_id