Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
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

May 20, 2007
April 3, 2012
February 2006
December 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00476502 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Genetic Polymorphisms in Thai HIV-1 Infected Patients on SQV/r
Study of Genetic Polymorphisms of CYP 3A and MDR-1 Genes in Thai HIV-1 Infected Patients on Saquinavir/Ritonavir

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

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).

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

PBMC

Probability Sample

patients on stable SQV based HAART therapy

HIV Infections
Genetic: identify genetic polymorphism in Thai HIV infected
Gene sequencing of Cyp450 metabolic pathway
1
patients involved in structured interruption therapy
Intervention: Genetic: identify genetic polymorphism in Thai HIV infected
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00476502
HIV-NAT 031
Yes
The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
Roche Pharma AG
Principal Investigator: Kiat Ruxrungtham, MD The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
The HIV Netherlands Australia Thailand Research Collaboration
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP