Pediatric Nevirapine Resistance Study
|ClinicalTrials.gov Identifier: NCT00117728|
Recruitment Status : Unknown
Verified January 2006 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was: Recruiting
First Posted : July 8, 2005
Last Update Posted : June 29, 2007
|Condition or disease||Intervention/treatment||Phase|
|AIDS HIV Infections||Drug: nevirapine||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Relevance of Nevirapine Resistance|
|Study Start Date :||April 2005|
|Estimated Study Completion Date :||September 2010|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117728
|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|