Influence of Cytochrome P2B6 on Efavirenz Dose in HIV-infected Thai Patients

Phase 1

• Conditions: Cytochrome P-450 CYP2B6; Efavirenz; HIV
• Interventions: Drug: Efavirenz; Other: CYP450 2B6

• Registration Number: NCT02421289
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2014-04
• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-20
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-02
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 190

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CYP2B6 guided group	Efavirenz	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.
CYP2B6 guided group	CYP450 2B6	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.

Primary Outcome Measures

Name	Time	Method
HIV RNA	24 weeks

Secondary Outcome Measures

Name	Time	Method
Neuropsychiatric adverse events	24 weeks

Trial Locations

Locations (1)

Faculty of medicine Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand