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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: | NCT00006167 |
There are no guidelines for appropriate nutritional management of weight loss or wasting in HIV infection. Some treatments may increase weight, but without improving muscle mass or quality of life. In this clinical trial AIDS patients with wasting are randomized to one of three nutritional strategies and studied over a 12-week period: 1) optimal oral nutrition with counseling and protein and calorie supplementation, and a placebo pill; 2) optimal oral nutrition with the oral androgen, oxandrolone at 20 mg daily; and 3) optimal oral nutrition with progressive resistance training (PRT). In all participants, dietary intervention is maximized by weekly personalized counseling to address individual issues and concerns. Two primary outcomes are assessed: thigh muscle mass and quality of life. Our findings can be used to develop guidelines for standards of nutritional care among AIDS patient with the wasting syndrome.
Condition | Intervention | Phase |
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HIV Wasting Syndrome |
Drug: oxandrolone Behavioral: Progressive Resistance Training |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pneumocystis carinii pneumonia Cryptococcal meningitis Cytomegalovirus retinitis or pneumonitis Toxoplasmosis Mycobacterium avium complex Visceral Kaposi's Sarcoma Lymphoma Pulmonary tuberculosis
United States, Massachusetts | |
Tufts University School of Medicine | |
Boston, Massachusetts, United States, 02111 |
Principal Investigator: | Sherwood Gorbach, MD | Tufts University |
Study Director: | Abby Shevitz, MD | Tufts University |
Study ID Numbers: | NIAW, DK51011 |
Study First Received: | August 8, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00006167 |
Health Authority: | United States: Federal Government |
oxandrolone AIDS wasting strength training |
progressive resistance training exercise dietary intervention |
Sexually Transmitted Diseases, Viral Metabolic Diseases HIV Wasting Syndrome Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Oxandrolone Virus Diseases |
HIV Infections Sexually Transmitted Diseases Nutrition Disorders Wasting Syndrome Metabolic disorder Retroviridae Infections |
Anabolic Agents RNA Virus Infections Pathologic Processes Disease Immune System Diseases Syndrome |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Lentivirus Infections Hormones Pharmacologic Actions Androgens |