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Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa

This study has been completed.
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
University of KwaZulu
Grey's Hospital
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00138047
First received: August 26, 2005
Last updated: December 2, 2005
Last verified: August 2005

August 26, 2005
December 2, 2005
March 2003
Not Provided
mean difference in log10 HIV-1 viral load at each visit
Same as current
Complete list of historical versions of study NCT00138047 on ClinicalTrials.gov Archive Site
  • mean difference in percentage of CD4+ T-cells at each visit
  • number of illness visits
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa
Randomized, Double-Blind, Placebo-Controlled Trial of Zinc Supplementation in HIV-1-Infected Children

The goal of the study is to rule out a harmful effect of zinc supplementation in HIV-1-infected children. The null hypothesis is that zinc supplementation will increase plasma HIV RNA levels.

A randomized, double-blind, placebo-controlled equivalence trial of zinc supplementation was conducted at Grey’s Hospital in Pietermaritzburg, South Africa. Ninety-six HIV-1-infected children were randomly assigned to receive 10 mg of elemental zinc as sulfate or placebo daily for 6 months. Baseline measurements of plasma HIV-1 viral load and the percentage of CD4+ T-lymphocytes were established at two study visits prior to randomization, and measurements were repeated 3, 6 and 9 months after starting supplementation. Plasma HIV-1 viral load and the percentage of CD4+ T-lymphocytes were compared before and after supplementation.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: zinc supplementation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2004
Not Provided

Inclusion Criteria:

  • HIV-infection
  • 6 to 60 months of age
  • Not receiving antiretroviral therapy
  • Cared for as outpatients at Grey’s Hospital

Exclusion Criteria:

  • Receiving antiretroviral therapy
Both
6 Months to 60 Months
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00138047
H.22.02.03.25.B1
Not Provided
Not Provided
Johns Hopkins Bloomberg School of Public Health
  • United States Agency for International Development (USAID)
  • University of KwaZulu
  • Grey's Hospital
Principal Investigator: William J Moss, MD, MPH Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Robert E Black, MD, MPH Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Raziya Bobat, MBChB, MD Nelson R Mandela School of Medicine, University of KwaZulu-Natal
Principal Investigator: Hoosen Coovadia, MD, MBBS Doris Duke Medical Research Institute, University of KwaZulu-Natal
Johns Hopkins Bloomberg School of Public Health
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP