Optimizing Pediatric HIV-1 Treatment, Nairobi, Kenya
Status:
Terminated
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
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).
Phase:
N/A
Details
Lead Sponsor:
University of Washington
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Fred Hutchinson Cancer Research Center National Institutes of Health (NIH) University of Nairobi