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Sponsors and Collaborators: |
The HIV Netherlands Australia Thailand Research Collaboration Swiss Cohort |
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Information provided by: | The HIV Netherlands Australia Thailand Research Collaboration |
ClinicalTrials.gov Identifier: | NCT00477308 |
In HIV-NAT 013 phase I study, genotyping was performed in 95 children on dual NRTI which showed that almost all children had resistance to NRTi. The HIV-NAT 013 phase II is a follow up study to evaluate treatment outcome after salvage therapy and the evolution of mutations.
Condition | Intervention | Phase |
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HIV Infections |
Procedure: salvage therapy |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Clinical, Immunologic and Virological Outcomes of Genotyping Directed Salvage Therapy in Children Who Have Failed Dual NRTIs |
Enrollment: | 95 |
Study Start Date: | January 2006 |
The HIV-NAT 013 study (conducted in 2003) evaluated prevalence and pattern of RT mutation in 95 children treated with dual NRTI. The study showed almost all children to have some degree of NRTI resistance and 40% with multi NRTI resistance. The mutation reported was major mutation.
After the study, the patients were managed based on the physician's judgment using genotyping results. The 95 patients in HIV-NAT 013 are categorized into 3 groups.
There are limited prospective studies evaluating outcome of decision regarding salvage therapy after genotyping results
There are also new mutations that are not considered major mutation that may affect treatment outcome
Knowledge learned from this study will benefit Thai children with NRTI resistance by helping pediatricians better choose salvage treatment options
Ages Eligible for Study: | 1 Year to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Thailand | |
Queen Sirikit National Institute of Child Health, Bangkok | |
Bangkok, Thailand, 10330 | |
Chulalongkorn Hospital | |
Bangkok, Thailand, 10330 | |
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) | |
Bangkok, Thailand, 10330 |
Principal Investigator: | Kiat Ruxrungtham, MD | The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) |
Principal Investigator: | Tawee Chotpitayasunondh, MD | Queen Sirikit National Institute of Child Health, Bangkok |
Study ID Numbers: | HIV-NAT 013 phase II |
Study First Received: | May 20, 2007 |
Last Updated: | November 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00477308 |
Health Authority: | Thailand: Ethical Committee |
HIV children genotypic resistance dual NRTIs Salvage therapy |
treatment outcome Salvage therapy based on genotyping results Treatment Failure |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |