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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00476502

First Posted: May 22, 2007

Last Update Posted: April 5, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Roche Pharma AG

Information provided by (Responsible Party):

The HIV Netherlands Australia Thailand Research Collaboration

Purpose

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

Condition	Intervention
HIV Infections	Genetic: identify genetic polymorphism in Thai HIV infected


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Genes and Gene Therapy HIV/AIDS

U.S. FDA Resources

Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Biospecimen Retention: Samples With DNA

PBMC


Enrollment:	250
Study Start Date:	February 2006
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 patients involved in structured interruption therapy	Genetic: identify genetic polymorphism in Thai HIV infected Gene sequencing of Cyp450 metabolic pathway

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).

Eligibility

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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

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 Submitted:	May 20, 2007
First Posted:	May 22, 2007
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

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