Status:
UNKNOWN
Pediatric Nevirapine Resistance Study
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsors:
Columbia University
University of Witwatersrand, South Africa
Conditions:
AIDS
HIV Infections
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE3
Brief Summary
This study is designed to test if a sequential protease-inhibitor (PI) - / nevirapine (NVP) -based regimen is effective for the treatment of HIV-infected children when previous NVP exposure has occurr...
Detailed Description
The wide use of NVP in pMTCT-prophylaxis may result in resistance to NNRTI and concomitantly limits the use of these drugs for the treatment of HIV-infected children. To avoid restricting treatment op...
Eligibility Criteria
Inclusion
- NVP-exposure as part of pMTCT-prophylaxis around delivery
- HIV-positive
- Eligible for treatment
- Plans to stay in the area for the next 6 months
Exclusion
- Already on anti-retroviral treatment
- History of toxicity to perinatal NVP
- Grade 3 or greater elevation of liver function tests
- Being treated for a severe acute opportunistic infection or tumor
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00117728
Start Date
April 1 2005
End Date
September 1 2010
Last Update
June 29 2007
Active Locations (1)
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1
Coronation Hospital
Johannesburg, South Africa