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:

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

History of Changes

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 Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Clinical Relevance of Nevirapine Resistance

Resource links provided by NLM:

MedlinePlus related topics: HIV/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 (Child)
Sexes Eligible for Study:	All
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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Shiau S, Kuhn L, Strehlau R, Martens L, McIlleron H, Meredith S, Wiesner L, Coovadia A, Abrams EJ, Arpadi SM. Sex differences in responses to antiretroviral treatment in South African HIV-infected children on ritonavir-boosted lopinavir- and nevirapine-based treatment. BMC Pediatr. 2014 Feb 12;14:39. doi: 10.1186/1471-2431-14-39.

Kuhn L, Coovadia A, Strehlau R, Martens L, Hu CC, Meyers T, Sherman G, Hunt G, Persaud D, Morris L, Tsai WY, Abrams EJ. Switching children previously exposed to nevirapine to nevirapine-based treatment after initial suppression with a protease-inhibitor-based regimen: long-term follow-up of a randomised, open-label trial. Lancet Infect Dis. 2012 Jul;12(7):521-30. doi: 10.1016/S1473-3099(12)70051-8. Epub 2012 Mar 16.

Coovadia A, Abrams EJ, Stehlau R, Meyers T, Martens L, Sherman G, Hunt G, Hu CC, Tsai WY, Morris L, Kuhn L. Reuse of nevirapine in exposed HIV-infected children after protease inhibitor-based viral suppression: a randomized controlled trial. JAMA. 2010 Sep 8;304(10):1082-90. doi: 10.1001/jama.2010.1278.


ClinicalTrials.gov Identifier:	NCT00117728 History of Changes
Other Study ID Numbers:	5R01HD047177 ( US NIH Grant/Contract Award Number )
Study First Received:	July 6, 2005
Last Updated:	June 28, 2007

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

ClinicalTrials.gov processed this record on June 23, 2017

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