A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss

In many HIV-infected individuals with prior weight loss, the failure to regain weight and lean tissue is at least in part the consequence of inadequate protein intake or ingestion of a poor-quality protein rather than total caloric intake. Dietary sources of protein are presumably inadequate to meet the high metabolic needs caused by HIV infection. To achieve a target protein intake in the range (1.5 to 2.0 g/kg/day) demonstrated in other catabolic diseases necessary to achieve positive nitrogen balance and to generate substantial anabolic effects, this study will administer a supplement containing high-quality protein.

Two groups of 28 patients each are randomly chosen to receive either an oral nutritional supplement (Optimune) containing increased amounts of high-quality protein (whey), which is rich in cysteine and glutamine, or an isocaloric, identical-tasting supplement without added whey protein or amino acid supplementation. Weight, body composition, anthropometry, dietary intake, and general physical health are assessed at baseline and at Weeks 6 and 12. Plasma cysteine, glutathione, C-reactive protein, and prealbumin, along with urine IL-6, sTNFrII, and IL-1ra, are assessed at baseline and at Week 12.

Inclusion criteria

You may be eligible for this study if you:

• Are HIV-positive.
• Are at least 18 years old.
• Have an HIV level less than 5,000 copies/ml within 30 days of study entry.
• Have lost weight in the past year, but your weight has remained fairly stable in the 2 months prior to enrollment.
• Are expected to live for at least 6 months.
• Are usually able to eat enough to maintain your present weight.
• Are able to complete a 3-day food diary.

Exclusion criteria

You will not be eligible for this study if you:

• Have gained a significant amount of weight in the past 2 months.
• Have any opportunistic (HIV-associated) infections.
• Are unable to eat enough food for any reason, or are on tube feeding.
• Have nausea, diarrhea, or vomiting in the 14 days prior to study entry.
• Are being treated for diabetes.
• Are receiving chemotherapy or radiation therapy to treat cancer.
• Are pregnant or breast-feeding.
• Are allergic to milk or mangoes.
• Have an implanted defibrillator.