drugset / Trial / NCT00006167

Nutrition Intervention in AIDS Wasting

NCT00006167

Double-blindTreatment

Summary

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.

Timeline

Start
1998-01
Primary completion
Completion
2000-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxandrolone Small molecule 20 mg Oral

Indications