Clinical Trials List
Protocol NumberYJ14001-COMBO-201801
NCT Number(ClinicalTrials.gov Identfier)NCT03595709
2018-04-01 - 2019-12-31
Phase III
Terminated2
ICD-10B20
Human immunodeficiency virus [HIV] disease
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
-
Trial Applicant
-
Sponsor
Yu-Jay Corp.
-
Trial scale
Taiwan Multiple Center
-
Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 莊祐中 Division of Infectious Disease
- CHIEN-CHING HUNG Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
HIV Infections
Objectives
The primary objective is to evaluate plasma EFV concentration at Week 4 in HIV-infected
patients, after switch to Combo treatment by measuring the proportion of subjects
achieving plasma EFV concentration >1.0 mg/L.
Test Drug
Efavirenz / Tenofovir Disoproxil Fumarate / Lamivudine 400/300/300 mg Tablet
Active Ingredient
Efavirenz/Tenofovir Disoproxil Fumarate/Lemivudine
Dosage Form
Tablet
Dosage
400/300/300
Endpoints
Primary Endpoint:
• The proportion of subjects achieving EFV concentration >1
mg/L at Week 4 after switch to co-formulated TDF/ 3TC/
EFV (400 mg) (Combo).
Secondary Endpoints:
• The proportion of subjects with undetectable plasma HIV-1
viral load (<50 copies/mL) at Week 12
• The proportion of subjects with undetectable plasma HIV-1
viral load (<50 copies/mL) at Week 24
• Mean changes from baseline in EFV concentration
• Mean changes from baseline in CD4+ T cells at Week 12 and 24
• Adherence to therapy
• Safety profile
• The proportion of subjects achieving EFV concentration >1
mg/L at Week 4 after switch to co-formulated TDF/ 3TC/
EFV (400 mg) (Combo).
Secondary Endpoints:
• The proportion of subjects with undetectable plasma HIV-1
viral load (<50 copies/mL) at Week 12
• The proportion of subjects with undetectable plasma HIV-1
viral load (<50 copies/mL) at Week 24
• Mean changes from baseline in EFV concentration
• Mean changes from baseline in CD4+ T cells at Week 12 and 24
• Adherence to therapy
• Safety profile
Inclution 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.
• 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
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 (AST) and/or aspartate
aminotransferase (ALT) levels >5x upper limit of normal
(ULN)
• Pregnant women or nursing mothers or women of potential
childbearing not utilizing contraceptive method (For
example, Non-Hormonal intrauterine device, condom and
uterine diaphragm).
• 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, and St John's Wort.
• 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 (AST) and/or aspartate
aminotransferase (ALT) levels >5x upper limit of normal
(ULN)
• Pregnant women or nursing mothers or women of potential
childbearing not utilizing contraceptive method (For
example, Non-Hormonal intrauterine device, condom and
uterine diaphragm).
• 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, and St John's Wort.
The Estimated Number of Participants
-
Taiwan
50 participants
-
Global
50 participants
