Pediatric Nevirapine Resistance Study
Recruitment status was Recruiting
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Relevance of Nevirapine Resistance|
- Virologic suppression at 6 months after randomization
- 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
|Study Start Date:||April 2005|
|Estimated Study Completion Date:||September 2010|
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.
|Johannesburg, South Africa|
|Contact: Ashraf Coovadia, MD +27 (0) 11 470 9290/9317 firstname.lastname@example.org|
|Principal Investigator:||Louise Kuhn, Ph.D.||Columbia University|