Multi-vitamins, HAART and HIV/AIDS in Uganda

Study Overview
=================
Brief Summary
-----------------
The investigators are conducting a double-blind, placebo controlled,randomized trial of multivitamin supplements(containing B-vitamins, C, and E) to determine their efficacy in slowing disease progression, indicated by increased CD4 count, weight gain, and improved quality of life, and decreased morbidity, mortality, and drug-related adverse events (i.e. peripheral neuropathy, anemia, and diarrhea). The investigators hypothesize that daily multivitamin supplementation will: (1) improve immune reconstitution; (2) improve weight gain, and (3) improve quality of life.

Detailed Description
-----------------
Antiretroviral therapy, gradually becoming the standard of care in developing countries, confers enormous benefits and yet substantial morbidity remains in human immunodeficiency virus (HIV) positive populations. Multivitamin supplements have immune-enhancing effects, and supplements were found to improve immunologic status and reduce morbidity and mortality among HIV-positive Tanzanian women in pre-highly active anti-retroviral therapy (HAART) stages of disease. These supplements are thought to be required to restore adequate nutrient levels in the context of HIV infection. This study will enroll 400 men and women in the Kampala district of Uganda, who are receiving or have recently initiated HAART. At baseline and monthly thereafter, research physicians and nurses at study clinics will assess each participant's clinical status and undertake study procedures. Each participant will be followed for 18 months, or until his/her death or loss to follow-up. Home visits will be conducted if participants miss their scheduled clinic appointments. We will perform nutritional assessments (anthropometry and dietary intake) at enrollment and several follow-up points, and laboratory measurements (CD4 cell counts and complete blood counts) every six months. Importantly, all study participants will continue receiving the standard of care according to national guidelines for the entire study period. Multivitamins could be a low-cost, adjunct therapy for helping to alleviate disease burden and elevate quality of life in HIV-infected individuals on HAART. At the same time, their efficacy could help preserve limited drug regimens in developing settings by postponing the need for switches to second line regimens of HAART. Our proposal represents a collaboration between the Harvard School of Public Health, Infectious Disease Institute and Makerere University School of Public Health in Kampala, Uganda.

Official Title
-----------------
Multi-vitamins, HAART and HIV/AIDS in Uganda

Conditions
-----------------
HIV/AIDS

Intervention / Treatment
-----------------
* Dietary Supplement: Multivitamin supplements B,C and E


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men or women aged >=18 years old HIV-positive initiating anti-retroviral therapy at the time of randomization or have been on highly active anti-retroviral therapy (HAART) for no more than 6 months have no intention of migrating, or re-locating >= 20 km outside of the Infectious Disease Institute (IDI), or Kiswa Health Center within the next 18 months after enrollment agree to allow home visit(s) and subsequent follow-up contacts as part of the study provide written informed consent Exclusion Criteria: pregnant Women individuals from whom we are unable to obtain written informed consent will be excluded from the study. For example, patients that are extremely ill and unable to consent will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multivitamins (B,C,E)<br> | Dietary Supplement: Multivitamin supplements B,C and E<br>* One daily recommended dietary allowance of multivitamins B,C and E or placebo taken daily for 18 months<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Multivitamin supplements B,C and E<br>* One daily recommended dietary allowance of multivitamins B,C and E or placebo taken daily for 18 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Gain |  | 18 months | 
| Immune Reconstitution | Immune Reconstitution is measured by change in CD4 cell count | 18 months | 
| Improved Quality of Life |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New or recurrent disease progression event |  | 18 months | 
| Reduce the probability of changing drug therapy (indicated by switching from first- to second-line therapy) |  | 18 months | 
| Reduce HAART-associated adverse events (indicated by incident peripheral neuropathy, severe anemia, or diarrhea). |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multivitamins, HIV/AIDS, Immune reconstitution, Weight Gain, Quality of Life