- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00476502
Study of Genetic Polymorphisms in Thai HIV-1 Infected Patients on SQV/r
April 3, 2012 updated by: The HIV Netherlands Australia Thailand Research Collaboration
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Observational
Enrollment (Actual)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bangkok, Thailand, 10330
- The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients on stable SQV based HAART therapy
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
patients involved in structured interruption therapy
|
Gene sequencing of Cyp450 metabolic pathway
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kiat Ruxrungtham, MD, The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
May 20, 2007
First Submitted That Met QC Criteria
May 21, 2007
First Posted (Estimate)
May 22, 2007
Study Record Updates
Last Update Posted (Estimate)
April 5, 2012
Last Update Submitted That Met QC Criteria
April 3, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIV-NAT 031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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