Multi-vitamins, HAART and HIV/AIDS in Uganda

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Makerere University
Infectious Disease Institute, Kampala, Uganda
Information provided by (Responsible Party):
Wafaie Fawzi, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01228578
First received: October 15, 2010
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
HIV/AIDS
Dietary Supplement: Multivitamin supplements B,C and E
Phase 3

Study Type: Interventional
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
Official Title: Multi-vitamins, HAART and HIV/AIDS in Uganda

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • Weight Gain [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Immune Reconstitution [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Immune Reconstitution is measured by change in CD4 cell count

  • Improved Quality of Life [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • New or recurrent disease progression event [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Reduce the probability of changing drug therapy (indicated by switching from first- to second-line therapy) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Reduce HAART-associated adverse events (indicated by incident peripheral neuropathy, severe anemia, or diarrhea). [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multivitamins (B,C,E) 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
Placebo Comparator: Placebo 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228578

Locations
Uganda
Makerere University School of Public Health / Infectious Disease Institute
Kampala, Uganda
Sponsors and Collaborators
Harvard School of Public Health
Makerere University
Infectious Disease Institute, Kampala, Uganda
Investigators
Principal Investigator: Wafaie W Fawzi, MD,MPH,DrPH Harvard School of Public Health
Principal Investigator: David Guwatudde, MPH, PhD Makerere University School of Public Health
  More Information

No publications provided by Harvard School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wafaie Fawzi, Principal Investigator, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01228578     History of Changes
Other Study ID Numbers: HD060333-01
Study First Received: October 15, 2010
Last Updated: May 9, 2013
Health Authority: Uganda: National Drug Authority
United States: Institutional Review Board

Keywords provided by Harvard School of Public Health:
Multivitamins
HIV/AIDS
Immune reconstitution
Weight Gain
Quality of Life

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014