A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss
- Conditions
- HIV Wasting SyndromeHIV Infections
- Registration Number
- NCT00001079
- Brief Summary
To test the hypothesis that the predominant accrual of fat rather than lean body mass (LBM) that occurs during treatment of HIV-associated wasting with megestrol acetate may be improved by treatment with megestrol acetate and testosterone enanthate in combination.
Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV. Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss. Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss. However, the weight gained during treatment with megestrol acetate was predominantly or exclusively fat. An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate, a progestational agent. Hypogonadism is associated with an increase in body fat and a decrease in LBM. Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy. This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism.
- Detailed Description
Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV. Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss. Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss. However, the weight gained during treatment with megestrol acetate was predominantly or exclusively fat. An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate, a progestational agent. Hypogonadism is associated with an increase in body fat and a decrease in LBM. Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy. This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism.
This is a 24 week study consisting of a 12 week double blind, randomized comparison Phase II trial of megestrol acetate and testosterone enanthate in combination versus megestrol acetate plus testosterone enanthate placebo in HIV associated wasting and a 12 week open label follow up of the combination therapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Memorial Sloan-Kettering Cancer Ctr.
🇺🇸New York, New York, United States
USC CRS
🇺🇸Los Angeles, California, United States
UCLA CARE Center CRS
🇺🇸Los Angeles, California, United States
Hosp. of the Univ. of Pennsylvania CRS
🇺🇸Philadelphia, Pennsylvania, United States
Ucsf Aids Crs
🇺🇸San Francisco, California, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Queens Med. Ctr.
🇺🇸Honolulu, Hawaii, United States
Howard University Hosp., Div. of Infectious Diseases, ACTU
🇺🇸Washington, District of Columbia, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Indiana Univ. School of Medicine, Wishard Memorial
🇺🇸Indianapolis, Indiana, United States
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins Adult AIDS CRS
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
🇺🇸Boston, Massachusetts, United States
St. Louis ConnectCare, Infectious Diseases Clinic
🇺🇸Saint Louis, Missouri, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
Cornell University A2201
🇺🇸New York, New York, United States
Beth Israel Med. Ctr. (Mt. Sinai)
🇺🇸New York, New York, United States
Duke Univ. Med. Ctr. Adult CRS
🇺🇸Durham, North Carolina, United States
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States