Cytochrome P-450 CYP2B6, Efavirenz, HIV
Conditions
Keywords
CYP2B6 polymorphism, efavirenz, Thai, HIV-infected patient, pharmacogenomic
Brief 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.
Interventions
DRUGEfavirenz
There will be adjusted dose of efavirenz in CYP2B6 guide group
OTHERCYP450 2B6
All patients will be monitored drug level which should be in therapeutic level.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years old * Anti-HIV positive * Naïve to antiretroviral drugs * Meet the criteria to start ART to Thai National guidelines * Sign inform consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HIV RNA | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Neuropsychiatric adverse events | 24 weeks |
Countries
Thailand
Contacts
Primary ContactPansachee Damronglerd, M.D.
Backup ContactSasisopin Kiertiburanakul, M.D., M.H.S.
Outcome results
None listed