Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pediatric Nevirapine Resistance Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Columbia University
University of Witwatersrand, South Africa
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier:
First received: July 6, 2005
Last updated: June 28, 2007
Last verified: January 2006

July 6, 2005
June 28, 2007
April 2005
Not Provided
Virologic suppression at 6 months after randomization
Same as current
Complete list of historical versions of study NCT00117728 on Archive Site
  • 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
Same as current
Not Provided
Not Provided
Pediatric Nevirapine Resistance Study
Clinical Relevance of Nevirapine Resistance

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).

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.

Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • AIDS
  • HIV Infections
Drug: nevirapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2010
Not Provided

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
up to 24 Months
South Africa
Not Provided
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Columbia University
  • University of Witwatersrand, South Africa
Principal Investigator: Louise Kuhn, Ph.D. Columbia University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP