NCT00138047

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
Last Updated

December 5, 2005

Status Verified

August 1, 2005

First QC Date

August 26, 2005

Last Update Submit

December 2, 2005

Conditions

HIV Infections

Keywords

zincHIVchildren

Outcome Measures

Primary Outcomes (1)

  • mean difference in log10 HIV-1 viral load at each visit

Secondary Outcomes (2)

  • mean difference in percentage of CD4+ T-cells at each visit

  • number of illness visits

Interventions

zinc supplementationDRUG

Eligibility Criteria

Age6 Months - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Receiving antiretroviral therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grey's Hospital

Pietermaritzburg, South Africa

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 30, 2005

Study Start

March 1, 2003

Study Completion

September 1, 2004

Last Updated

December 5, 2005

Record last verified: 2005-08

Locations

ZA(1)