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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 3

Locations

Taiwan

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Efavirenz, HIV Infections

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

E-Da Hospital
National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

C12 EFV concentration

The proportion of subjects achieving C12 EFV concentration >1.0 mg/L at Week 4.

Secondary Outcome Measures

HIV-1 RNA load

The proportion of subjects with undetectable plasma HIV-1 RNA load (<50 copies/mL) at Week 12

HIV-1 RNA load

The proportion of subjects with undetectable plasma HIV-1 RNA load (<50 copies/mL) at Week 24

EFV concentration

The mean changes from baseline in C12 EFV concentration at Week 4.

CD4+ T cell count

The mean changes from baseline in CD4+ T cell count at Week 12.

CD4+ T cell count

The mean changes from baseline in CD4+ T cell count at Week 24.

Full Information

NCT ID

NCT03595709

First Posted

July 2, 2018

Last Updated

February 5, 2020

Sponsor

Yu-Jay Corp.

1. Study Identification

Unique Protocol Identification Number

NCT03595709

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

December 6, 2018 (Actual)

Primary Completion Date

March 6, 2019 (Actual)

Study Completion Date

July 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yu-Jay Corp.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

Efavirenz, HIV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Model Description

Single-arm, open-label

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

non applicable

Intervention Description

Primary Outcome Measure Information:

Title

C12 EFV concentration

Description

The proportion of subjects achieving C12 EFV concentration >1.0 mg/L at Week 4.

Time Frame

Week 4

Secondary Outcome Measure Information:

Title

HIV-1 RNA load

Description

The proportion of subjects with undetectable plasma HIV-1 RNA load (<50 copies/mL) at Week 12

Time Frame

Week 12

Title

HIV-1 RNA load

Description

The proportion of subjects with undetectable plasma HIV-1 RNA load (<50 copies/mL) at Week 24

Time Frame

Week 24

Title

EFV concentration

Description

The mean changes from baseline in C12 EFV concentration at Week 4.

Time Frame

Week 4

Title

CD4+ T cell count

Description

The mean changes from baseline in CD4+ T cell count at Week 12.

Time Frame

Week 12

Title

CD4+ T cell count

Description

The mean changes from baseline in CD4+ T cell count at Week 24.

Time Frame

Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hsin-Yun Sun, MD

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

E-Da Hospital

City

Kaohsiung

ZIP/Postal Code

82445

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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