Impact of Nutrition Intervention on HIV/AIDS Infected Patients

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.

Inclusion Criteria:

• HIV positive individuals in the age range 18 to 50 years.
• Individuals whose CD4 count was between 300-550 cells/uL.
• Individuals who met the study criteria and were interested in being enrolled.
• Individuals not on ARV therapy.
• Women who were not pregnant.

Exclusion Criteria:

• On the clinician's advice, individuals could be excluded from enrollment.
• Individuals who were unable to carry out the study intervention e.g. homeless, impaired mental state etc.
• Individuals who were unlikely to complete follow-up based on pre-enrolment assessment.