Impact of Nutrition Intervention on HIV/AIDS Infected Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase 3 Study That Assesses the Impact of a Nutrition Intervention on HIV/AIDS Infected Patients: Kingston, Jamaica

Conditions
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Human Immunodeficiency Virus (HIV), Acquired Immune Deficiency Syndrome (AIDS)

Intervention / Treatment
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* Dietary Supplement: Theragran-M; Ensure Plus
* Dietary Supplement: Theragran-M


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ensure Plus + Multivitamin/Counselling<br> | Dietary Supplement: Theragran-M; Ensure Plus<br>* Theragran-M: One tablet daily for 6-months. Ensure Plus: One 8 fl.oz. bottle daily for 6-months. Nutritional counselling: at baseline, and at monthly follow-up visits.<br>|
| Active Comparator: Multivitamin/Counselling<br> | Dietary Supplement: Theragran-M<br>* Theragran-M: One tablet daily for 6-months. Nutritional counselling: at baseline and at monthly follow-up visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of nutritional intervention on anthropometry in HIV infected individuals. | Body Mass Index | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of nutritional intervention on the clinical and immune status in HIV infected individuals. | Immune status (CD4 cell count, total lymphocyte count), antioxidant status. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS, Nutrition Therapy, Dietary Supplement, Antioxidant, Immunity, CD4 count, Anthropometry, Body Mass Index