Clinical trial NCT00095212: Androgen Effects in HIV-infected Women
Official title: Androgen Effects in HIV-infected Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Keywords: HIV
women
androgen
Treatment Experienced
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2004-11-02
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Lean Body Mass
timeFrame: Baseline (time 0) to 18 months
Secondary outcomes:
measure: Bone Mineral Density of the Hip
timeFrame: Baseline (time 0) to 18 months
measure: Quality of Life/Depression: Becks Depression Inventory
timeFrame: Baseline (time 0) to 18 months
measure: Quality of Life/Sexual Function: Brief Index of Sexual Function (BISF-W) Domain 7: Problems Affecting Sexual Function
timeFrame: Baseline (time 0) to 18 months
measure: Safety: Number of Subjects Reporting a Skin Reaction to the Patch
timeFrame: Baseline (time 0) to 18 months
measure: Safety: Number of Subjects Reporting a Change in Hair Pattern (Increased Hair on Chin, Upper Lip, Chest, Abdomen, Fore Arms, and Legs)
timeFrame: Baseline (time 0) to 18 months
measure: Safety: Number of Subjects Reporting Acne
timeFrame: Baseline (time 0) to 18 months
measure: Safety: Number of Subjects Reporting a Change in Menstrual Status (Reported More Than One Period in 1 Month or Missed a Period During a Monthly Cycle)
timeFrame: Baseline (time 0) to 18 months
measure: Neurocognitive Function: Hopkins Verbal Learning Test-revised,"Total Recall" Z Score Represents Change in Z Score From Baseline to 18 Months.
timeFrame: Baseline (time 0) to 18 months
measure: Strength: Total Knee Flexion Performed Via Quantitative Muscle Function Testing.
timeFrame: Baseline (time 0) to 18 months
measure: Strength: Total Knee Extension Performed Via Quantitative Muscle Function Testing.
timeFrame: Baseline (time 0) to 18 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mass General Hospital
state: Massachusetts
Study officials:
References:
citation: 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.