Pediatric Nevirapine Resistance Study

Phase 3

• Conditions: AIDS; HIV Infections

• Registration Number: NCT00117728
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

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 options for children, it is desirable to preserve NVP for both pMTCT and first line treatment. This study will therefore test whether resistance-caused treatment failures of HIV-infected and previously NVP-exposed children can be avoided if the NVP treatment is preceded by an initial PI-based regimen.

Comparison: HIV-infected children less than 24 months of age, exposed to any pMTCT regimen that included NVP and who achieve and maintain viral suppression for at least 3 months with a PI-based regimen will be randomized to one of the two groups: (1) to continue on PI-containing regimen or (2) to be switched off the PI-containing regimen onto the NVP-containing regimen. The study outcome will be proportions in the two groups who have complete virologic suppression at 6 months after randomization.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-07-06
• Study First Submitted QC: 2005-07-07
• Study First Posted: 2005-07-08
• Status Verified: 2006-01
• Last Update Submitted: 2007-06-28
• Last Update Posted: 2007-06-29
• Study Completion: 2010-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Virologic suppression at 6 months after randomization

Secondary Outcome Measures

Name	Time	Method
To compare the time to virologic failure up to 18 months post randomization
to examine the associations between detection of drug resistance mutation and virologic response to treatment
to compare the toxicity profiles and adherence in the two groups
to describe the emergence of genotypic resistance in the two groups

Trial Locations

Locations (1)

Coronation Hospital; 🇿🇦 Johannesburg, South Africa