Influence of Cytochrome P2B6 on Efavirenz Dose in HIV-inf... | NCT02421289

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

NCT02421289

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Aug 4, 2015Estimated

Enrollment

190Estimated

Phase

Phase 1

Conditions

Cytochrome P-450 CYP2B6
Efavirenz
HIV

Interventions

Efavirenz
Efavirenz
CYP450 2B6

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Apr 2014Actual

Completion Date

Not provided

First Submitted Date

Apr 8, 2015

First Submission Date that Met QC Criteria

Apr 15, 2015

First Posted Date

Apr 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2015

Last Update Posted Date

Aug 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

190Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CYP2B6 guided group	Experimental	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 Other: CYP450 2B6
control group	No Intervention	Patients were promptly ART initiation regardless CYP2B6 results. Treatments were efvirenz 600 mg, tenofovir 300 mg and lamivudine 300 mg.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Efavirenz	Drug	There will be adjusted dose of efavirenz in CYP2B6 guide group	CYP2B6 guided group

Measure	Description	Time Frame
HIV RNA		24 weeks

Measure	Description	Time Frame
Neuropsychiatric adverse events		24 weeks

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pansachee Damronglerd, M.D.	Contact	+66 8515-6188		joh_pum@yahoo.com
Sasisopin Kiertiburanakul, M.D., M.H.S.	Contact			sasisopin@hotmail.com

Overall Officials

Name	Affiliation	Role
Pansachee Damronglerd, M.D.	Faculty of medicine Ramathibodi Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine Ramathibodi Hospital	Recruiting	Bangkok	Bangkok	10400	Thailand

Type	Date	Date Unknown
Release	Apr 29, 2016
Reset	Jun 6, 2016

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 29, 2016			Jun 6, 2016

Intervention Browse Module

MeSH Terms

ID	Term
C098320	efavirenz

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided