Pediatric Nevirapine Resistance Study
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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
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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

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Ages Eligible for Study: | up to 24 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
South Africa | |
Coronation Hospital | Recruiting |
Johannesburg, South Africa | |
Contact: Ashraf Coovadia, MD +27 (0) 11 470 9290/9317 coovadiaah@paedshiv.wits.ac.za |
Principal Investigator: | Louise Kuhn, Ph.D. | Columbia University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00117728 History of Changes |
Other Study ID Numbers: |
5R01HD047177 ( U.S. NIH Grant/Contract ) |
First Posted: | July 8, 2005 Key Record Dates |
Last Update Posted: | June 29, 2007 |
Last Verified: | January 2006 |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Non-nucleoside reverse transcriptase inhibitor Drug Resistance HIV Seronegativity Treatment Naive |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Nevirapine |
Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |