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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Columbia University University of Witwatersrand, South Africa |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00117728 |
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 |
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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 |
Estimated Enrollment: | 250 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | September 2010 |
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.
Ages Eligible for Study: | up to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
South Africa | |
Coronation Hospital | Recruiting |
Johannesburg, South Africa | |
Contact: Ashraf Coovadia, MD +27 (0) 11 470 9290/9317 coovadiaah@paedshiv.wits.ac.za |
Principal Investigator: | Louise Kuhn, Ph.D. | Columbia University |
Study ID Numbers: | 5R01HD47177 |
Study First Received: | July 6, 2005 |
Last Updated: | June 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00117728 |
Health Authority: | United States: Federal Government |
Non-nucleoside reverse transcriptase inhibitor Drug Resistance HIV Seronegativity Treatment Naive |
Virus Diseases Nevirapine Sexually Transmitted Diseases, Viral HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |