Status:
TERMINATED
Optimizing Pediatric HIV-1 Treatment in Infants With Prophylactic Exposure to Nevirapine, Nairobi, Kenya
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief Summary
Globally, children who acquire HIV-1 increasingly do so in the context of maternal antiretroviral prophylaxis. It is important to determine whether maternal antiretroviral prophylaxis should alter inf...
Detailed Description
Hypotheses 1. Infants older than 6 months who do not have detectable nevirapine resistance on genotypic testing will respond equivalently to a nevirapine-sparing or a nevirapine-containing HAART regi...
Eligibility Criteria
Inclusion
- 6-18 months age
- HIV-1 DNA detection with confirmation (positive on two HIV-1 DNA filter paper tests)
- Mother exposed to NVP-containing PMTCT regimen during currently ended pregnancy and/or infant received NVP-containing PMTCT regimen
- Infant susceptible to NVP (i.e. no detectable NVP resistance on genotypic testing)
- Caregiver of infant plans to reside in Nairobi for at least 3 years
- Caregiver is able to provide sufficient location information
Exclusion
- Infant has received any prior antiretroviral therapy (expect prophylaxis for PMTCT)
- Infant has evidence of active tuberculosis
- Mother currently receiving NVP-containing HAART and breastfeeding the infant
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00427297
Start Date
September 1 2007
End Date
December 1 2009
Last Update
August 27 2018
Active Locations (1)
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1
Kenyatta National Hospital, University of Nairobi
Nairobi, Kenya