A Phase 4 interventional study of oxandrolone and Progressive Resistance Training in HIV Wasting Syndrome, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-01-13.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 4, Interventional, and Treatment
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.
196 studies on the registry are indexed under Wasting Syndrome; 22 are open to participants now.
Browse Wasting Syndrome studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.
Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.
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Exclusion Criteria:
Pneumocystis carinii pneumonia Cryptococcal meningitis Cytomegalovirus retinitis or pneumonitis Toxoplasmosis Mycobacterium avium complex Visceral Kaposi's Sarcoma Lymphoma Pulmonary tuberculosis
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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HIV Wasting Syndrome
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)