Status:
TERMINATED
Optimizing Pediatric HIV-1 Treatment, Nairobi, Kenya
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Fred Hutchinson Cancer Center
University of Nairobi
Conditions:
HIV Infections
Eligibility:
All Genders
Up to 54 years
Phase:
NA
Brief 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 sta...
Detailed Description
Hypothesis: Deferring antiretroviral therapy in infants who have immune reconstitution and adequate growth following early therapy of primary infection (initiated HAART during primary infection at les...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- A. Infants newly initiating HAART
- Less than 13 months of age
- HIV-1 DNA detection with confirmation (positive on two HIV-1 DNA filter paper tests)
- Caregiver of infant plans to reside in Nairobi for at least 3 years (reported by caregiver)
- Caregiver is able to provide sufficient location information
- B. Infants already receiving HAART
- Initiated HAART at \<13 months of age
- Records confirming HIV positive status
- Documentation of CD4% and weight prior to HAART initiation
- Must be on 1st line drug regimen
- Eligibility for randomization:
- Completed 24 months of treatment with HAART
- Normalized growth: weight for height z-score (WHZ) \> -0.5; Child's weight must be above the 5th weight-for-age percentile and the weight curve must not be flat or falling (i.e. cross 2 major percentile lines or more over the past 3 months)
- CD4% \> 25
- Children who recently initiated or who require anti-tuberculosis treatment at the time of randomization will be ineligible for randomization.
Exclusion
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00428116
Start Date
September 1 2007
End Date
December 1 2014
Last Update
July 26 2018
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