Trial Information

Summary: Investigational Supplement for Quality of Life and Health of HIV Positive Patients

This is a 10-week Phase II/III, proof-of-concept, randomized, double-blinded, placebo-controlled study to evaluate the effects of punica granatum (pomegranate) juice on the indices of quality of life in HIV-1 positive volunteers. Eligible volunteers will be randomized in a 1:1:1 ratio to receive one of two formulations of pomegranate juice (once daily, 8-ounce) or a placebo. Volunteers who originally received the placebo and completed participation in the 10 week study will be re-randomized to receive one of two pomegranate juice formulations for 8-weeks.

Patient Inclusion Criteria

• HIV-1 positive adult at least 18 years of age
• CD4 cell count above 350 cells/mm3
• Treatment naïve or not currently on antiretroviral therapy for at least 90 days prior to the screening visit

Patient Exclusion Criteria

• No current use of immune modulating therapies (i.e., IL-2, vaccine, Interferon gamma)

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