Despite the high frequency of wasting in AIDS patients, with estimates ranging from 18% to 50%, there exist no guidelines for appropriate nutritional management of this condition. In this clinical trial AIDS patients with wasting will be 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; 2) optimal oral nutrition with the oral androgen, oxandrolone at 40mg daily; and 3)optimal oral nutrition with progressive resistance training (PRT). Dietary intervention will be maximized by several mechanisms including an expanded recruitment procedure to address personal concerns and weekly appointments. Two primary outcomes will be assessed: total body weight and physical functioning. Secondary outcomes will include fat-free mass by DEXA scan, muscle mass, muscle strength, biological and clinical responses of HIV infection (viral burden, CD4 lymphocytes counts, opportunistics infections), and other measures of health status such as HIV and nutrition-related symptoms, mental health, and general health perceptions. In addition, cost-effectiveness will be compared in the three intervention arms by determining costs of utilization of all medical services. A multidisplinary team of investigators, including a nutritionist, AIDS clinician, HIV biologist, exercise physiologist, health outcomes researcher, medical economist, and biostatistician, is collaborating to carry out this project. Our findings can be used to develop guidelines for standards of nutritional care among AIDS patient with the wasting syndrome.
Showing the most recent 10 out of 412 publications
