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NCT00476502 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
Study of Genetic Polymorphisms of CYP 3A and MDR-1 Genes in Thai HIV-1 Infected Patients on Saquinavir/Ritonavir

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00476502
Other study ID # HIV-NAT 031
Secondary ID
Status Completed
Phase N/A
First received May 20, 2007
Last updated April 3, 2012
Start date February 2006
Est. completion date December 2008

Study information
Verified date April 2012
Source The HIV Netherlands Australia Thailand Research Collaboration
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Observational

Clinical Trial Summary

Study of genetic polymorphisms of CYP #A and MDR-1 genes in Thai HIV-1 infected patients on saquinavir/ritonavir.

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).

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Genetic:
• identify genetic polymorphism in Thai HIV infected
Gene sequencing of Cyp450 metabolic pathway

Locations
Country Name City State
Thailand The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) Bangkok

Sponsors (2)
Lead Sponsor Collaborator
The HIV Netherlands Australia Thailand Research Collaboration Roche Pharma AG

Country where clinical trial is conducted

Thailand, 

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