Multi-vitamins, HAART and HIV/AIDS in Uganda

HIV/AIDS Clinical Trial

Official title:

Multi-vitamins, HAART and HIV/AIDS in Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228578
• Other study ID #: HD060333-01
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2010
• Last updated: May 20, 2014
• Start date: April 2010
• Est. completion date: November 2013

Study information

• Verified date: May 2014
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Drug AuthorityUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

Dietary Supplement:
• Multivitamin supplements B,C and E
One daily recommended dietary allowance of multivitamins B,C and E or placebo taken daily for 18 months

Locations

Country	Name	City	State
Uganda	Makerere University School of Public Health / Infectious Disease Institute	Kampala

Sponsors (3)

Lead Sponsor	Collaborator
Harvard School of Public Health	Infectious Disease Institute, Kampala, Uganda, Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Gain		18 months	No
Primary	Immune Reconstitution	Immune Reconstitution is measured by change in CD4 cell count	18 months	No
Primary	Improved Quality of Life		18 months	No
Secondary	New or recurrent disease progression event		18 months	No
Secondary	Reduce the probability of changing drug therapy (indicated by switching from first- to second-line therapy)		18 months	No
Secondary	Reduce HAART-associated adverse events (indicated by incident peripheral neuropathy, severe anemia, or diarrhea).		18 months	No