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

NCT02421289 | Unknown Phase 1

• 1 other identifier: ID 05-56-13
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytochrome P-450 CYP2B6; Efavirenz; HIV

Keywords

CYP2B6 polymorphism; efavirenz; Thai; HIV-infected patient; pharmacogenomic

Outcome Measures

Primary Outcomes (1)

• HIV RNA

  24 weeks

Secondary Outcomes (1)

• Neuropsychiatric adverse events

  24 weeks

Study Arms (2)

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

Efavirenz DRUG

There will be adjusted dose of efavirenz in CYP2B6 guide group

CYP2B6 guided group

CYP450 2B6 OTHER

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

CYP2B6 guided group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old
• Anti-HIV positive
• Naïve to antiretroviral drugs
• Meet the criteria to start ART to Thai National guidelines
• Sign inform consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of medicine Ramathibodi Hospital

Bangkok, Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Interventions

efavirenz

Study Officials

• Pansachee Damronglerd, M.D.

  Faculty of medicine Ramathibodi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pansachee Damronglerd, M.D.

CONTACT

+66 8515-6188; joh_pum@yahoo.com

Sasisopin Kiertiburanakul, M.D., M.H.S.

CONTACT

sasisopin@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ramathibodi Hospital

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 20, 2015
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Last Updated: August 4, 2015

Record last verified: 2015-08

Locations

TH (1)