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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02421289
• Other study ID #: ID 05-56-13
• Status: Unknown status
• Phase: Phase 1
• First received: April 8, 2015
• Last updated: August 2, 2015
• Start date: April 2013

Study information

• Verified date: August 2015
• Source: Mahidol University
• Contact: Pansachee Damronglerd, M.D.
• Phone: +66 8515-6188
• Email: joh_pum[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 190
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cytochrome P-450 CYP2B6
• Efavirenz
• HIV

Intervention

Drug:
• Efavirenz
There will be adjusted dose of efavirenz in CYP2B6 guide group
• 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.

Locations

Country	Name	City	State
Thailand	Faculty of medicine Ramathibodi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV RNA		24 weeks
Secondary	Neuropsychiatric adverse events		24 weeks