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Optimizing Pediatric HIV-1 Treatment, Nairobi, Kenya

NCT00428116 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-07-26

Study results available
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Summary

Given the high mortality associated with infant HIV-1 and the fact that surrogate markers are poorly predictive of mortality risk,empiric highly active antiretroviral therapy (HAART) initiation is started in infants younger than 12 months. A problem with this approach is that it obligates infants to life-long therapy, which may be associated with cumulative drug toxicity, poor adherence, and treatment failure. Early HAART for prevention of mortality during the first 2 years of life has potential to salvage immune function and alter viral set-point, allowing withdrawal of therapy, perhaps for several years, until subsequent CD4% decline requires it. This untested approach is attractive because it combines the survival benefits of early pediatric HAART therapy with the benefits of antiretroviral deferral.

One hundred and fifty infants who initiated HAART at \<13 months of age will be treated with HAART regimen for 24 months after which those who have immune reconstitution and adequate growth (\~100) will be randomized to continued versus deferred therapy. Clinical outcomes, growth, and toxicity will be compared in these children to determine if interruption is a safe and beneficial strategy. Follow-up in this studies will be closely monitored by an external Data Safety and Monitoring Board (DSMB).

Conditions

  • HIV Infections

Interventions

DRUG

HAART

Combination first line antiretrovirals as previously described.

Sponsors & Collaborators

  • Fred Hutchinson Cancer Center

    collaborator OTHER

  • University of Nairobi

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Dalton Wamalwa, MMed, MPH · Department of Paediatrics and Child Health, Kenyatta National Hospital, University of Nairobi

  • Grace C John-Stewart, MD, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
54 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2013-07-31
Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00428116 on ClinicalTrials.gov