Trials / Unknown
UnknownNCT02421289
Influence of Cytochrome P2B6 on Efavirenz Dose in HIV-infected Thai Patients
Influence of Cytochrome P2B6 on Efavirenz Dose in HIV-infected Thai Patients in a Prospective Randomized Controlled Trial: a Proof-of-concept Study
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 190 (estimated)
- Sponsor
- Mahidol University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Efavirenz | There will be adjusted dose of efavirenz in CYP2B6 guide group |
| DRUG | Efavirenz | If the patients was diagnosed as hypersensitivity to EFV, they will receive boosted-PI instead. |
| OTHER | CYP450 2B6 | All patients will be monitored drug level which should be in therapeutic level. |
Timeline
- Start date
- 2013-04-01
- Primary completion
- 2014-04-01
- First posted
- 2015-04-20
- Last updated
- 2015-08-04
Locations
1 site across 1 country: Thailand
Source: ClinicalTrials.gov record NCT02421289. Inclusion in this directory is not an endorsement.