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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cytochrome P-450 CYP2B6 Efavirenz HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CYP2B6 guided group

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.

Group Type EXPERIMENTAL

Efavirenz

Intervention Type DRUG

There will be adjusted dose of efavirenz in CYP2B6 guide group

Efavirenz

Intervention Type DRUG

If the patients was diagnosed as hypersensitivity to EFV, they will receive boosted-PI instead.

CYP450 2B6

Intervention Type OTHER

All patients will be monitored drug level which should be in therapeutic level.

control group

Patients were promptly ART initiation regardless CYP2B6 results. Treatments were efvirenz 600 mg, tenofovir 300 mg and lamivudine 300 mg.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Efavirenz

There will be adjusted dose of efavirenz in CYP2B6 guide group

Intervention Type DRUG

Efavirenz

If the patients was diagnosed as hypersensitivity to EFV, they will receive boosted-PI instead.

Intervention Type DRUG

CYP450 2B6

All patients will be monitored drug level which should be in therapeutic level.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No