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Study of Genetic Polymorphisms in Thai HIV-1 Infected Patients on SQV/r

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ClinicalTrials.gov Identifier: NCT00476502
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : April 5, 2012
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Study of genetic polymorphisms of CYP #A and MDR-1 genes in Thai HIV-1 infected patients on saquinavir/ritonavir.

Condition or disease Intervention/treatment
HIV Infections Genetic: identify genetic polymorphism in Thai HIV infected

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).

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Study of Genetic Polymorphisms of CYP 3A and MDR-1 Genes in Thai HIV-1 Infected Patients on Saquinavir/Ritonavir
Study Start Date : February 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
1
patients involved in structured interruption therapy
 Genetic: identify genetic polymorphism in Thai HIV infected
Gene sequencing of Cyp450 metabolic pathway


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples With DNA
PBMC

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients on stable SQV based HAART therapy
Criteria

Inclusion Criteria:

  • HIV-infected persons who have been enrolled in the Staccato study
  • On low-dose ritonavir boosted saquinavir at the time blood samples are collected

Exclusion Criteria:

  • Inability to understand the nature and extent of the study and the procedures required
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476502


Locations
Thailand
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, Thailand, 10330
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Roche Pharma AG
Investigators
Principal Investigator: Kiat Ruxrungtham, MD The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)  This link exits the ClinicalTrials.gov site

Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT00476502     History of Changes
Other Study ID Numbers: HIV-NAT 031
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: April 5, 2012
Last Verified: April 2012

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
genetic polymorphism
CYP 3A
MDR-1
 Thai
HIV
Treatment Experienced

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