The wasting syndrome, defined as weight loss of 10 percent or more, is a devastating complication of AIDS. Despite the high frequency of wasting in AIDS patients, with estimates ranging from 18 to 50 percent, no guidelines exist 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) dietary counseling alone; (2) optimal oral nutrition using a peptide-based supplement and an appetite stimulant, megestrol acetate, along with dietary counseling; and 3) enteral nutrition using nocturnal enteral supplementation through a percutaneous endoscopically-placed gastrostomy (PEG) and dietary counseling. Patients will be seen at baseline, 6 weeks, and 12 weeks for data collection. Dietary counseling will be given at the baseline and 6 week visits and during biweekly telephone calls. Compliance will be maximized by several mechanisms including an expanded recruitment procedure to address personal concerns and the biweekly telephone calls. Two primary outcomes will be assessed: total body weight and physical functioning. Secondary outcomes will include lean body mass, biological and clinical responses of HIV infection (viral burden, CD4 lymphocyte counts, opportunistic infection), 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 multi-disciplinary team of researchers, including a nutritionist, AIDS clinician, gastroenterologist, HIV virologist, 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 patients with the wasting syndrome.
| Beaston-Blaakman, A; Shepard, D S; Stone, N et al. (2007) Cost-effectiveness of clinical interventions for AIDS wasting. AIDS Care 19:996-1001 |
| Shevitz, Abby H; Wilson, Ira B; McDermott, Ann Y et al. (2005) A comparison of the clinical and cost-effectiveness of 3 intervention strategies for AIDS wasting. J Acquir Immune Defic Syndr 38:399-406 |
| Shevitz, A H; Knox, T A (2001) Nutrition in the era of highly active antiretroviral therapy. Clin Infect Dis 32:1769-75 |
