Study of Genetic Polymorphisms in Thai HIV-1 Infected Patients on SQV/r
This study has been completed.
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00476502
First received: May 20, 2007
Last updated: April 3, 2012
Last verified: April 2012
| Tracking Information | |||||
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| First Received Date ICMJE | May 20, 2007 | ||||
| Last Updated Date | April 3, 2012 | ||||
| Start Date ICMJE | February 2006 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00476502 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Genetic Polymorphisms in Thai HIV-1 Infected Patients on SQV/r | ||||
| Official Title ICMJE | Study of Genetic Polymorphisms of CYP 3A and MDR-1 Genes in Thai HIV-1 Infected Patients on Saquinavir/Ritonavir | ||||
| Brief Summary | Study of genetic polymorphisms of CYP #A and MDR-1 genes in Thai HIV-1 infected patients on saquinavir/ritonavir. |
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| Detailed Description | Genetic polymorphisms will be investigated by polymerase-chain reaction (PCR) and drug levels of saquinavir will be determined by high phase liquid chromatography with UV-detected (HPLC). |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: PBMC |
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| Sampling Method | Probability Sample | ||||
| Study Population | patients on stable SQV based HAART therapy |
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| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE | Genetic: identify genetic polymorphism in Thai HIV infected
Gene sequencing of Cyp450 metabolic pathway |
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| Study Group/Cohort (s) | 1
patients involved in structured interruption therapy
Intervention: Genetic: identify genetic polymorphism in Thai HIV infected |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 250 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Thailand | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00476502 | ||||
| Other Study ID Numbers ICMJE | HIV-NAT 031 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | The HIV Netherlands Australia Thailand Research Collaboration | ||||
| Study Sponsor ICMJE | The HIV Netherlands Australia Thailand Research Collaboration | ||||
| Collaborators ICMJE | Roche Pharma AG | ||||
| Investigators ICMJE |
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| Information Provided By | The HIV Netherlands Australia Thailand Research Collaboration | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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