Pediatric Nevirapine Resistance Study

This study is currently recruiting participants.

Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), January 2006

First Received: July 6, 2005 Last Updated: June 28, 2007 History of Changes

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Clinical Relevance of Nevirapine Resistance

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Nevirapine

U.S. FDA Resources

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

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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Columbia University

University of Witwatersrand, South Africa

Investigators

Principal Investigator:

Louise Kuhn, Ph.D.

Columbia University

More Information

No publications provided

Study ID Numbers:	5R01HD47177
Study First Received:	July 6, 2005
Last Updated:	June 28, 2007
ClinicalTrials.gov Identifier:	NCT00117728 History of Changes
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:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Nevirapine
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010