HIV InfectionsNCT00476502
Study of Genetic Polymorphisms in Thai HIV-1 Infected Patients on SQV/r
An observational study of HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
Trial summary
Study of genetic polymorphisms of CYP #A and MDR-1 genes in Thai HIV-1 infected patients on saquinavir/ritonavir. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- identify genetic polymorphism in Thai HIV infected
- How many people
- 250 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2006to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients on stable SQV based HAART therapy
Who may be able to join
- HIV-infected persons who have been enrolled in the Staccato study
- On low-dose ritonavir boosted saquinavir at the time blood samples are collected
Who cannot join
- Inability to understand the nature and extent of the study and the procedures required
Trial locations and contacts
1 site in 1 country.
Thailand1 site
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, Bangkok, 10330
About this study
Official title: 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.
Read the 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).
- Conditions
- HIV Infections
- Being tested
- identify genetic polymorphism in Thai HIV infected
- Keywords
- genetic polymorphism, CYP 3A, MDR-1, Thai, HIV, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
identify genetic polymorphism in Thai HIV infectedGenetic
Gene sequencing of Cyp450 metabolic pathway
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients involved in structured interruption therapy Receives: Genetic: identify genetic polymorphism in Thai HIV infected |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startFeb 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Kiat Ruxrungtham, MD, Principal investigator, The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476502
- Sponsor's protocol ID
- HIV-NAT 031
- Status last verified
- Apr 2012
- First submitted
- 20 May 2007
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Genetic Polymorphisms of CYP 3A and MDR-1 Genes in Thai HIV-1 Infected Patients on Saquinavir/Ritonavir
- ClinicalTrials.gov ID
- NCT00476502
- Acronym / sponsor ID
- HIV-NAT 031
- Conditions
- HIV Infections
- Keywords
- genetic polymorphism, CYP 3A, MDR-1, Thai, HIV, Treatment Experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Feb 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Genetic: identify genetic polymorphism in Thai HIV infectedpatients involved in structured interruption therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients on stable SQV based HAART therapy
Key inclusion criteria (2 listed)
- HIV-infected persons who have been enrolled in the Staccato study
- On low-dose ritonavir boosted saquinavir at the time blood samples are collected
Key exclusion criteria (1 listed)
- Inability to understand the nature and extent of the study and the procedures required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| identify genetic polymorphism in Thai HIV infectedGene sequencing of Cyp450 metabolic pathway | Genetic | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2012.
- The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiat Ruxrungtham, MD principal investigator
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2012; AzTrials last refreshed its copy on 7 Nov 2026.