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Pediatric Nevirapine Resistance Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2006 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00117728

First Posted: July 8, 2005

Last Update Posted: June 29, 2007

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Columbia University

University of Witwatersrand, South Africa

Information provided by:

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

Tracking Information

First Submitted Date ^ICMJE

July 6, 2005

First Posted Date ^ICMJE

July 8, 2005

Last Update Posted Date

June 29, 2007

Start Date ^ICMJE

April 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Virologic suppression at 6 months after randomization

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00117728 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pediatric Nevirapine Resistance Study

Official Title ^ICMJE

Clinical Relevance of Nevirapine Resistance

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).

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

AIDS
HIV Infections

Intervention ^ICMJE

Drug: nevirapine

Study Arms

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

250

Estimated Completion Date

September 2010

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

up to 24 Months (Child)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

South Africa

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00117728

Other Study ID Numbers ^ICMJE

5R01HD047177( U.S. NIH Grant/Contract )

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Columbia University
University of Witwatersrand, South Africa

Investigators ^ICMJE

Principal Investigator:

Louise Kuhn, Ph.D.

Columbia University

PRS Account

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

Verification Date

January 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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