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

This study has been completed.

First Received: May 20, 2007 Last Updated: April 21, 2009 History of Changes

Sponsors and Collaborators:	The HIV Netherlands Australia Thailand Research Collaboration Hoffmann-La Roche
Information provided by:	The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:	NCT00476502

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:	Cohort, 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: AIDS

U.S. FDA Resources

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

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Hoffmann-La Roche

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

No publications provided

Responsible Party:	HIV-NAT ( Kiat Ruxrungtham )
Study ID Numbers:	HIV-NAT 031
Study First Received:	May 20, 2007
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00476502 History of Changes
Health Authority:	Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:

genetic polymorphism
CYP 3A
MDR-1

Thai
HIV
Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Saquinavir
Ritonavir
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 03, 2009