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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001079 |
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.
Condition | Intervention | Phase |
HIV Infections HIV Wasting Syndrome |
Drug: Testosterone enanthate Drug: Megestrol acetate |
Phase II |
MedlinePlus related topics: | AIDS Weight Control |
Drug Information available for: | Megestrol acetate Megestrol Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Stanolone |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
Official Title: | Double-Blind Randomized Comparison Phase II Trial of Megestrol Acetate and Testosterone Enanthate in Combination Versus Megestrol Acetate Plus Testosterone Enanthate Placebo in Human Immunodeficiency Virus (HIV)-Associated Wasting. |
Estimated Enrollment: | 80 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Female patients:
Concurrent Medication:
Excluded:
Patients with the following prior conditions will be excluded:
Female patients:
Prior Medication:
Excluded:
Excluded within 30 days prior to entry:
United States, California | |||||
San Francisco Gen Hosp | |||||
San Francisco, California, United States, 941102859 | |||||
UCLA CARE Ctr | |||||
Los Angeles, California, United States, 90095 | |||||
Univ of Southern California / LA County USC Med Ctr | |||||
Los Angeles, California, United States, 900331079 | |||||
United States, Colorado | |||||
Univ of Colorado Health Sciences Ctr | |||||
Denver, Colorado, United States, 80262 | |||||
United States, District of Columbia | |||||
Howard Univ | |||||
Washington, District of Columbia, United States, 20059 | |||||
United States, Hawaii | |||||
Queens Med Ctr | |||||
Honolulu, Hawaii, United States, 96816 | |||||
Univ of Hawaii | |||||
Honolulu, Hawaii, United States, 96816 | |||||
United States, Illinois | |||||
Northwestern Univ Med School | |||||
Chicago, Illinois, United States, 60611 | |||||
United States, Indiana | |||||
Indiana Univ Hosp | |||||
Indianapolis, Indiana, United States, 462025250 | |||||
Division of Inf Diseases/ Indiana Univ Hosp | |||||
Indianapolis, Indiana, United States, 46202 | |||||
United States, Louisiana | |||||
Charity Hosp / Tulane Univ Med School | |||||
New Orleans, Louisiana, United States, 70112 | |||||
Tulane Univ School of Medicine | |||||
New Orleans, Louisiana, United States, 70112 | |||||
United States, Maryland | |||||
Johns Hopkins Hosp | |||||
Baltimore, Maryland, United States, 21287 | |||||
United States, Massachusetts | |||||
Beth Israel Deaconess - West Campus | |||||
Boston, Massachusetts, United States, 02215 | |||||
United States, Missouri | |||||
St Louis Regional Hosp / St Louis Regional Med Ctr | |||||
St Louis, Missouri, United States, 63112 | |||||
United States, New York | |||||
Mem Sloan - Kettering Cancer Ctr | |||||
New York, New York, United States, 10021 | |||||
Cornell Univ Med Ctr | |||||
New York, New York, United States, 10021 | |||||
Beth Israel Med Ctr | |||||
New York, New York, United States, 10003 | |||||
United States, North Carolina | |||||
Duke Univ Med Ctr | |||||
Durham, North Carolina, United States, 27710 | |||||
United States, Pennsylvania | |||||
Univ of Pennsylvania at Philadelphia | |||||
Philadelphia, Pennsylvania, United States, 19104 | |||||
United States, South Carolina | |||||
Julio Arroyo | |||||
West Columbia, South Carolina, United States, 29169 |
Study Chair: | Schambelan M | |
Study Chair: | Mulligan K | |
Study Chair: | Von Roenn JH |
Click here for more information about Megestrol acetate 
  |
Schambelan M, Zackin R, Mulligan K, Sattler FR, Chesney M, Stevens M, Edwards L, Egorin MJ, Von Roenn JH. Effect of testosterone (T) on the response to megesterol acetate (MA) in patients with HIV-associated wasting: a randomized, double-blind placebo-controlled trial (ACTG 313). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 640)
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Study ID Numbers: | ACTG 313 |
First Received: | November 2, 1999 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00001079 |
Health Authority: | United States: Federal Government |
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