Trial Information

Summary: New Investigational Anti-HIV Supplement

This is a 56-week Phase III, randomized, double-blinded, placebo-controlled study investigating the effects of one-year administration of a nutritional supplement on immunological status in HIV-1 positive adults on no antiretroviral therapy. The investigational product is a nutritional supplement consisting of a special blend of fibers, proteins, and fats constituted as a powder. Eligible volunteers will be randomized in a 1:1 ratio to receive a nutritional supplement or placebo for 52 weeks, plus four weeks of follow up.

Patient Inclusion Criteria

• HIV-1 positive adult at least 18 years of age infected for at least 9 months
• CD4 cell count less than or equal to 800 cells/ml in the past 3 months before the screening visit
• Viral load greater than 5,000 copies/ml in the past 3 months before the screening visit

Patient Exclusion Criteria

• Allergies to milk or milk product
• History of diabetes

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Trial listings updated: June 1, 2008 at 6:32:50 AM