NCT00476502

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 5, 2012

Status Verified

April 1, 2012

Enrollment Period

2.8 years

First QC Date

May 20, 2007

Last Update Submit

April 3, 2012

Conditions

HIV Infections

Keywords

genetic polymorphismCYP 3AMDR-1ThaiHIVTreatment Experienced

Study Arms (1)

1

patients involved in structured interruption therapy

Genetic: identify genetic polymorphism in Thai HIV infected

Interventions

identify genetic polymorphism in Thai HIV infectedGENETIC

Gene sequencing of Cyp450 metabolic pathway

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients on stable SQV based HAART therapy

You may qualify if:

  • HIV-infected persons who have been enrolled in the Staccato study
  • On low-dose ritonavir boosted saquinavir at the time blood samples are collected

You may not qualify if:

  • Inability to understand the nature and extent of the study and the procedures required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Bangkok, Bangkok, 10330, Thailand

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

PBMC

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Kiat Ruxrungtham, MD

    The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2007

First Posted

May 22, 2007

Study Start

February 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 5, 2012

Record last verified: 2012-04

Locations

TH(1)