Pediatric Nevirapine Resistance Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Relevance of Nevirapine Resistance

Conditions
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AIDS, HIV Infections

Intervention / Treatment
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* Drug: nevirapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nevirapine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic suppression at 6 months after randomization |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-nucleoside reverse transcriptase inhibitor, Drug Resistance, HIV Seronegativity, Treatment Naive