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NCT02421289 Clinical Trial

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
Secondary ID
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
Health authority
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. completion date
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

Study Design

Related Conditions & MeSH terms

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
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