Study of Genetic Polymorphisms in Thai HIV-1 Infected Pat... | NCT00476502

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

NCT00476502

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Status

Completed

Last Update Posted

Apr 5, 2012Estimated

Enrollment

250Actual

Phase

Not provided

Conditions

HIV Infections

Interventions

identify genetic polymorphism in Thai HIV infected

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

May 20, 2007

First Submission Date that Met QC Criteria

May 21, 2007

First Posted Date

May 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2012

Last Update Posted Date

Apr 5, 2012Estimated

Name	Class
Roche Pharma AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		patients involved in structured interruption therapy	Genetic: identify genetic polymorphism in Thai HIV infected

Interventions

Name	Type	Description	Arm Group Labels	Other Names
identify genetic polymorphism in Thai HIV infected	Genetic	Gene sequencing of Cyp450 metabolic pathway	1

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients on stable SQV based HAART therapy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kiat Ruxrungtham, MD	The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)		Bangkok	Bangkok	10330	Thailand

References Module

Citations

Not provided

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral