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

NCT02421289 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2015-08-04

No results posted yet for this study

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

  • Cytochrome P-450 CYP2B6
  • Efavirenz
  • HIV

Interventions

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.

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Pansachee Damronglerd, M.D. · Faculty of medicine Ramathibodi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-04-30

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02421289 on ClinicalTrials.gov