Pediatric Nevirapine Resistance Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Columbia University
University of Witwatersrand, South Africa
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00117728
First received: July 6, 2005
Last updated: June 28, 2007
Last verified: January 2006
  Purpose

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 Intervention Phase
AIDS
HIV Infections
Drug: nevirapine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Relevance of Nevirapine Resistance

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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

Estimated Enrollment: 250
Study Start Date: April 2005
Estimated Study Completion Date: September 2010
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.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117728

Locations
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
Columbia University
University of Witwatersrand, South Africa
Investigators
Principal Investigator: Louise Kuhn, Ph.D. Columbia University
  More Information

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00117728     History of Changes
Other Study ID Numbers: 5R01HD47177
Study First Received: July 6, 2005
Last Updated: June 28, 2007
Health Authority: United States: Federal Government

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:
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Nevirapine
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 22, 2014