Pediatric Nevirapine Resistance Study

Tracking Information
First Submitted Date ICMJE	July 6, 2005
First Posted Date ICMJE	July 8, 2005
Last Update Posted Date	June 29, 2007
Study Start Date ICMJE	April 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: July 7, 2005)	Virologic suppression at 6 months after randomization
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00117728 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 7, 2005)	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
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Pediatric Nevirapine Resistance Study
Official Title ICMJE	Clinical Relevance of Nevirapine Resistance
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 Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	AIDS; HIV Infections
Intervention ICMJE	Drug: nevirapine
Study Arms	Not Provided
Publications *	Strehlau R, Kuhn L, Abrams EJ, Coovadia A. HIV-associated neurodevelopmental delay: prevalence, predictors and persistence in relation to antiretroviral therapy initiation and viral suppression. Child Care Health Dev. 2016 Nov;42(6):881-889. doi: 10.1111/cch.12399. Epub 2016 Aug 22.; Shiau S, Kuhn L, Strehlau R, Martens L, McIlleron H, Meredith S, Wiesner L, Coovadia A, Abrams EJ, Arpadi SM. Sex differences in responses to antiretroviral treatment in South African HIV-infected children on ritonavir-boosted lopinavir- and nevirapine-based treatment. BMC Pediatr. 2014 Feb 12;14:39. doi: 10.1186/1471-2431-14-39.; Kuhn L, Coovadia A, Strehlau R, Martens L, Hu CC, Meyers T, Sherman G, Hunt G, Persaud D, Morris L, Tsai WY, Abrams EJ. Switching children previously exposed to nevirapine to nevirapine-based treatment after initial suppression with a protease-inhibitor-based regimen: long-term follow-up of a randomised, open-label trial. Lancet Infect Dis. 2012 Jul;12(7):521-30. doi: 10.1016/S1473-3099(12)70051-8. Epub 2012 Mar 16.; Coovadia A, Abrams EJ, Stehlau R, Meyers T, Martens L, Sherman G, Hunt G, Hu CC, Tsai WY, Morris L, Kuhn L. Reuse of nevirapine in exposed HIV-infected children after protease inhibitor-based viral suppression: a randomized controlled trial. JAMA. 2010 Sep 8;304(10):1082-90. doi: 10.1001/jama.2010.1278.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: July 7, 2005)	250
Original Enrollment ICMJE	Same as current
Estimated Study Completion Date	September 2010
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	up to 24 Months (Child)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	South Africa
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00117728
Other Study ID Numbers ICMJE	5R01HD047177( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators ICMJE	Columbia University; University of Witwatersrand, South Africa
Investigators ICMJE	Principal Investigator: Louise Kuhn, Ph.D. Columbia University
PRS Account	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Verification Date	January 2006
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP