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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00260143 |
Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy including fat. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).
Condition | Intervention | Phase |
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HIV Associate Weight Loss |
Drug: testosterone enanthate |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Testosterone and Physical Function in HIV Associate Weight Loss |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following blood test results:
United States, California | |
Charles R. Drew University | |
Los Angeles, California, United States |
Principal Investigator: | Shalender Bhasin, MD | Charles R. Drew University and Boston University Medical Center |
Study ID Numbers: | DK49296, CDU IRB#: 00-11-153-04 |
Study First Received: | November 29, 2005 |
Last Updated: | November 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00260143 |
Health Authority: | United States: Food and Drug Administration |
HIV+ men Treatment Experienced |
Body Weight Signs and Symptoms Testosterone HIV Infections Weight Loss |
Acquired Immunodeficiency Syndrome Body Weight Changes Methyltestosterone Testosterone 17 beta-cypionate |
Anabolic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions Androgens |