Pediatric Nevirapine Resistance Study
Primary Purpose
AIDS, HIV Infections
Status
Unknown status
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
nevirapine
Sponsored by
About this trial
This is an interventional treatment trial for AIDS focused on measuring Non-nucleoside reverse transcriptase inhibitor, Drug Resistance, HIV Seronegativity, Treatment Naive
Eligibility Criteria
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
Sites / Locations
- Coronation HospitalRecruiting
Outcomes
Primary Outcome Measures
Virologic suppression at 6 months after randomization
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00117728
First Posted
July 6, 2005
Last Updated
June 28, 2007
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Columbia University, University of Witwatersrand, South Africa
1. Study Identification
Unique Protocol Identification Number
NCT00117728
Brief Title
Pediatric Nevirapine Resistance Study
Official Title
Clinical Relevance of Nevirapine Resistance
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Columbia University, University of Witwatersrand, South Africa
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS, HIV Infections
Keywords
Non-nucleoside reverse transcriptase inhibitor, Drug Resistance, HIV Seronegativity, Treatment Naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
nevirapine
Primary Outcome Measure Information:
Title
Virologic suppression at 6 months after randomization
Secondary Outcome Measure Information:
Title
To compare the time to virologic failure up to 18 months post randomization
Title
to examine the associations between detection of drug resistance mutation and virologic response to treatment
Title
to compare the toxicity profiles and adherence in the two groups
Title
to describe the emergence of genotypic resistance in the two groups
10. Eligibility
Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise Kuhn, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coronation Hospital
City
Johannesburg
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashraf Coovadia, MD
Phone
+27 (0) 11 470 9290/9317
Email
coovadiaah@paedshiv.wits.ac.za
12. IPD Sharing Statement
Citations:
PubMed Identifier
27546069
Citation
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.
Results Reference
derived
PubMed Identifier
24521425
Citation
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.
Results Reference
derived
PubMed Identifier
22424722
Citation
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.
Results Reference
derived
PubMed Identifier
20823434
Citation
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.
Results Reference
derived
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Pediatric Nevirapine Resistance Study
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