Pediatric Nevirapine Resistance Study

• Status: Unknown status
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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 occurred as part of programs to prevent mother-to-child transmission (pMTCT).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Collaborators: Columbia University; University of Witwatersrand, South Africa
• Treatments: Nevirapine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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