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

• Status: Completed
• Trial end date: 2019-07-16
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yu-Jay Corp.
• Treatments: Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine

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.