Human Immunodeficiency Virus (HIV) Clinical Trial
Official title:
Phase 3 Study That Assesses the Impact of a Nutrition Intervention on HIV/AIDS Infected Patients: Kingston, Jamaica
Intervention to investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.
To investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV
positive patients with a CD4 count in the range 300-550 cells/ul.
A total of 120 participants will be stratified by age and gender and randomly assigned to
two treatment arms. Sixty (60) participants will be assigned to receive dietary counselling
and a multivitamin/mineral supplement, with sixty (60) additionally receiving an oral
Medical Nutritional Supplement (MNS).
Participants will be followed for six months post-randomization: at baseline, 3 months and 6
months. The principal outcome measure is Body Mass Index, used as a proxy for 'nutritional
status'. Secondary outcome measures include immune status and antioxidant status.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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