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

August 2, 2015 updated by: Pansachee DAMRONGLERD, Mahidol University

Influence of Cytochrome P2B6 on Efavirenz Dose in HIV-infected Thai Patients in a Prospective Randomized Controlled Trial: a Proof-of-concept Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

190

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pansachee Damronglerd, M.D.
  • Phone Number: +66 8515-6188
  • Email: joh_pum@yahoo.com

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Recruiting
        • Faculty of Medicine Ramathibodi Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: control group
Patients were promptly ART initiation regardless CYP2B6 results. Treatments were efvirenz 600 mg, tenofovir 300 mg and lamivudine 300 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV RNA
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Neuropsychiatric adverse events
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Pansachee Damronglerd, M.D., Faculty of Medicine Ramathibodi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (Estimate)

April 20, 2015

Study Record Updates

Last Update Posted (Estimate)

August 4, 2015

Last Update Submitted That Met QC Criteria

August 2, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID 05-56-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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