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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
Information provided by:

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).

Condition or disease Intervention/treatment Phase
AIDS HIV Infections Drug: nevirapine Phase 3

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 Design

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Nevirapine
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Virologic suppression at 6 months after randomization

Secondary Outcome Measures :
  1. To compare the time to virologic failure up to 18 months post randomization
  2. to examine the associations between detection of drug resistance mutation and virologic response to treatment
  3. to compare the toxicity profiles and adherence in the two groups
  4. to describe the emergence of genotypic resistance in the two groups

Eligibility Criteria

Information from the National Library of Medicine

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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
Contacts and Locations

Information from the National Library of Medicine

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   
Sponsors and Collaborators
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
More Information

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
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