Therapeutic Drug Monitoring Study of Reduced-Dose Efavirenz (400 mg) in Combo Tablet for Patients Receiving Atripla With Viral Suppression in Taiwan

NCT ID: NCT03595709

Last Updated: 2020-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-06
• Study Completion Date: 2019-07-16

Brief Summary

Prospective, Therapeutic Drug Monitoring Study of Reduced-Dose Efavirenz (400 mg) Plus Tenofovir Disoproxil Fumarate (TDF) and Lamivudine in a Fixed-Dose Combination Tablet (Combo) for Patients Receiving Co-Formulated TDF, Emtricitabine and Efavirenz (Atripla) with Viral Suppression in Taiwan

Detailed Description

Efavirenz (EFV) is the most widely used non-nucleoside reverse transcriptase inhibitor (NNRTI). The recommended dose of EFV is 600 mg daily; however, a phase II study showed no significant difference in viral suppression rates across the different EFV groups (200 mg, 400 mg, and 600 mg) at 24 weeks. The week 96 analysis of ENCORE 1 study confirmed the durable virological non-inferiority of EFV 400 mg to the standard 600 mg dose when given as initial therapy with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Fewer EFV-related adverse events (AEs) and fewer treatment discontinuations were also observed in the reduced dose group. The efficacy and safety findings provide robust evidence to redefine the EFV dose for HIV treatment.

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

combined tablet (EFV 400,TDF 300, 3TC 300)

All eligible subjects will receive 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg) once daily for 24 weeks orally on empty stomach before bedtime. If the event of toxicity or tolerability issues requires a change from study drug, switching to the best available treatment will be recommended.

Group Type: EXPERIMENTAL

3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg)

Intervention Type: DRUG

All eligible subjects will receive 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg) once daily for 24 weeks orally on empty stomach before bedtime. If the event of toxicity or tolerability issues requires a change from study drug, switching to the best available treatment will be recommended.

Interventions

3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg)

All eligible subjects will receive 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg) once daily for 24 weeks orally on empty stomach before bedtime. If the event of toxicity or tolerability issues requires a change from study drug, switching to the best available treatment will be recommended.

Intervention Type: DRUG

Other Intervention Names

non applicable

Eligibility Criteria

Inclusion Criteria

• Patients who are receiving co-formulated TDF/ FTC/ EFV (600 mg) and have achieved an undetectable plasma viral load (<50 copies/mL) for 6 months or longer at screening visit.
• Having C12 EFV of 1 mg/L or greater at screening.
• (C12 EFV will be determined by using blood sample collected 12 ± 1 hour after previous dosing of co-formulated TDF/ FTC/ EFV (600 mg).
• No known treatment failure to regimens containing TDF, 3TC or FTC, plus EFV.
• Infected with HIV harboring no known resistance-associated mutations to EFV, TDF, 3TC or FTC.
• No known allergies to EFV, TDF, 3TC or FTC.
• Aged ≧20 years.
• Calculated creatinine clearance (ClCr) ≥ 50 mL/min (Cockcroft-Gault formula).
• Provision of written informed consent.

Exclusion Criteria

• The following laboratory values:

• Absolute neutrophil count (ANC) <500 cells/μL
• Hemoglobin <7.0 g/dL
• Platelet count <50,000 cells/μL
• Serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >5x upper limit of normal (ULN)
• Pregnant women or nursing mothers.
• Active opportunistic or malignant disease not under adequate control.
• Use of immunomodulators within 30 days prior to screening visit.
• Use any of the prohibited medications: bepridil, astemizole, terfenadine, dihydroergotamine, ergometrine, ergotamine, systemic cytotoxic chemotherapy, amodiaquine, pimozide, midazolam, triazolam, cisapride、St John's Wort、 Elbasvir/Grazoprevir and Simeprevir.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yu-Jay Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsin-Yun Sun, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

E-Da Hospital

Kaohsiung City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

YJ14001-COMBO-201801

Identifier Type: -

Identifier Source: org_study_id