Cytochrome P-450 CYP2B6Phase 1NCT02421289
Influence of Cytochrome P2B6 on Efavirenz Dose in HIV-infected Thai Patients
A Phase 1 study testing Efavirenz and CYP450 2B6 in people with Cytochrome P-450 CYP2B6 and Efavirenz, run by Mahidol University at 1 site in Thailand.
Trial summary
Genetic polymorphisms of cytochrome P450 2B6 (CYP2B6) are associated with lower rate of EFV metabolism and lead to high exposure, as well as a higher risk of neuropsychiatric adverse event especially homozygous variant CYP2B6 *6/*6. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytochrome P-450 CYP2B6, Efavirenz, HIV
- What is being tested?
- Efavirenz and CYP450 2B6
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2013to Apr 2014
- Phase
- Phase 1
- 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
Who may be able to join
- Age ≥18 years old
- Anti-HIV positive
- Naïve to antiretroviral drugs
- Meet the criteria to start ART to Thai National guidelines
- Sign inform consent
Who cannot join
- Body mass index (BMI) >25 kg/m²
- Pregnant women or breastfeeding
- Received drugs that may have interaction with EFV e.g. rifampicin, fluconazole (400-800 mg), ergot alkaloid, midazolam, triazolam, ritonavir, carbamazepine, phenytoin, phenobarbitone, St John's Wort
- Having active opportunistic infections e.g. tuberculosis, cryptococcosis, histoplasmosis, penicillosis
- Hepatic dysfunction as indicated by:
- Transaminases >5-10 × the upper limit of normal
- ALP >5-10 × the upper limit of normal
- Total bilirubin >2.5-5 × the upper limit of normal
Trial locations and contacts
1 site in 1 country.
Sasisopin Kiertiburanakul, M.D., M.H.S. contact
Thailand1 site, 1 recruiting
- Recruiting
Faculty of medicine Ramathibodi Hospital
Bangkok, Bangkok, 10400
Pansachee Damronglerd, M.D., +66 85-015-6188, joh_pum@yahoo.com
About this study
Official title: Influence of Cytochrome P2B6 on Efavirenz Dose in HIV-infected Thai Patients in a Prospective Randomized Controlled Trial: a Proof-of-concept Study
Genetic polymorphisms of cytochrome P450 2B6 (CYP2B6) are associated with lower rate of EFV metabolism and lead to high exposure, as well as a higher risk of neuropsychiatric adverse event especially homozygous variant CYP2B6 *6/*6. This trial was designed to compare the proportion of patients who had undetectable HIV RNA at 24 weeks after ART initiation between patient who did CYP 2B6 guided EFV dose and who did not.
- Conditions
- Cytochrome P-450 CYP2B6, Efavirenz, HIV
- Being tested
- Efavirenz, CYP450 2B6
- Keywords
- CYP2B6 polymorphism, efavirenz, Thai, HIV-infected patient, pharmacogenomic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfavirenzDrug
There will be adjusted dose of efavirenz in CYP2B6 guide group
EfavirenzDrug
If the patients was diagnosed as hypersensitivity to EFV, they will receive boosted-PI instead.
CYP450 2B6Other
All patients will be monitored drug level which should be in therapeutic level.
| Study group | Role | What they receive |
|---|---|---|
| CYP2B6 guided group | Experimental | Patients were assigned to perform CYP2B6 study before ART initiation. If CYP2B6 *6/*6 was found in CYP2B6 *6/*6, the patients will be initiated a low dose of 400 mg of efavirenz (2 tablets of 200 mg) with tenofovir 300 mg and lamivudine 300 mg. Receives: Drug: Efavirenz; Other: CYP450 2B6 |
| control group | No intervention | Patients were promptly ART initiation regardless CYP2B6 results. Treatments were efvirenz 600 mg, tenofovir 300 mg and lamivudine 300 mg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV RNA
Measured: 24 weeks
Secondary outcomes (1)
Neuropsychiatric adverse events
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startApr 2013
- Primary completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytochrome P-450 CYP2B6Studies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pansachee DAMRONGLERD, Mahidol University
- Investigators
- Pansachee Damronglerd, M.D., Principal investigator, Faculty of medicine Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421289
- Sponsor's protocol ID
- ID 05-56-13
- Status last verified
- Aug 2015
- First submitted
- 8 Apr 2015
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Cytochrome P2B6 on Efavirenz Dose in HIV-infected Thai Patients in a Prospective Randomized Controlled Trial: a Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT02421289
- Acronym / sponsor ID
- ID 05-56-13
- Conditions
- Cytochrome P-450 CYP2B6, Efavirenz, HIV
- Keywords
- CYP2B6 polymorphism, efavirenz, Thai, HIV-infected patient, pharmacogenomic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- First posted
- 20 Apr 2015 (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.
Genetic polymorphisms of cytochrome P450 2B6 (CYP2B6) are associated with lower rate of EFV metabolism and lead to high exposure, as well as a higher risk of neuropsychiatric adverse event especially homozygous variant CYP2B6 *6/*6. This trial was designed to compare the proportion of patients who had undetectable HIV RNA at 24 weeks after ART initiation between patient who did CYP 2B6 guided EFV dose and who did not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CYP2B6 guided group | Experimental | Drug: Efavirenz, Other: CYP450 2B6Patients were assigned to perform CYP2B6 study before ART initiation. If CYP2B6 *6/*6 was found in CYP2B6 *6/*6, the patients will be initiated a low dose of 400 mg of efavirenz (2 tablets of 200 mg) with tenofovir 300 mg and lamivudine 300 mg. |
| control group | No intervention | –Patients were promptly ART initiation regardless CYP2B6 results. Treatments were efvirenz 600 mg, tenofovir 300 mg and lamivudine 300 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old
- Anti-HIV positive
- Naïve to antiretroviral drugs
- Meet the criteria to start ART to Thai National guidelines
- Sign inform consent
Key exclusion criteria (8 listed)
- Body mass index (BMI) >25 kg/m²
- Pregnant women or breastfeeding
- Received drugs that may have interaction with EFV e.g. rifampicin, fluconazole (400-800 mg), ergot alkaloid, midazolam, triazolam, ritonavir, carbamazepine, phenytoin, phenobarbitone, St John's Wort
- Having active opportunistic infections e.g. tuberculosis, cryptococcosis, histoplasmosis, penicillosis
- Hepatic dysfunction as indicated by:
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 |
|---|---|---|
| EfavirenzThere will be adjusted dose of efavirenz in CYP2B6 guide group | Drug | CYP2B6 guided group |
| EfavirenzIf the patients was diagnosed as hypersensitivity to EFV, they will receive boosted-PI instead. | Drug | CYP2B6 guided group |
| CYP450 2B6All patients will be monitored drug level which should be in therapeutic level. | Other | CYP2B6 guided group |
Primary outcome
HIV RNA
Time frame: 24 weeks
1 secondary outcome
Neuropsychiatric adverse events
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
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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.
Sasisopin Kiertiburanakul, M.D., M.H.S. contact
Pansachee Damronglerd, M.D. principal investigator
Faculty of medicine Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Efavirenz and CYP450 2B6 in people with Cytochrome P-450 CYP2B6 and Efavirenz, run by Mahidol University 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 Aug 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pansachee Damronglerd, M.D. (+66 8515-6188, joh_pum@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV RNA (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
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 4 Aug 2015.