Testosterone and Physical Function in HIV+ Men
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|ClinicalTrials.gov Identifier: NCT00260143|
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : March 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV Associate Weight Loss||Drug: Testosterone enanthate Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Testosterone and Physical Function in HIV Associate Weight Loss|
|Actual Study Start Date :||May 2003|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||June 2006|
Experimental: Testosterone enanthate
300 mg of testosterone enanthate by intramuscular injection once weekly for 16 weeks
Drug: Testosterone enanthate
Placebo Comparator: Placebo
Placebo (sesame oil) by intramuscular injection once weekly for 16 weeks
- Stair climb [ Time Frame: 16 weeks ]A modification of the Margaria stair climb was used to assess stair-climbing power. participants were instructed to ascend a 12-step staircase as rapidly as possible, with ascent time recorded over the middle four steps (0.66 m) of the climb.
- Walking speed [ Time Frame: 16 weeks ]Participants were instructed to walk a 160-m flat course as fast as possible without running. Photoelectric cells and timers were used to determine time to the nearest 0.01 s. The faster of two trials was used to calculate walking speed (m/s).
- Load carry [ Time Frame: 16 weeks ]To simulate daily activities such as carrying groceries or suitcases, participants carried a load equal to 20% of their body weight while walking a distance of 20 m as fast as possible on a flat course.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260143
|United States, California|
|Charles R. Drew University|
|Los Angeles, California, United States, 90059|
|Principal Investigator:||Shalender Bhasin, MD||Charles R. Drew University and Boston University Medical Center|