Clinical Trials

MainTitle

Reduced-Dose EFV 400 mg Plus TDF and 3TC in Combination Tablet for Patients Receiving Atripla With Viral Suppression

This study is ongoing, but not recruiting participants.
Sponsor
Yu-Jay Corp.


Information provided by (Responsible Party)
Yu-Jay Corp.
ClinicalTrials.gov Identifier
NCT03595709

First received: July 2, 2018
Last updated: February 10, 2019
Last Verified: February 2019
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV Infections

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm, open-label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Drug Monitoring Study of Reduced-Dose EFV 400 mg Plus TDF and 3TC in Combination Tablet for Patients Receiving Atripla With Viral Suppression in Taiwan

Further study details as provided by Yu-Jay Corp.:

Primary Outcome Measures

  • The proportion of subjects who achiev 3 EFV concentration>1 mg/L at week 4 after switching to co-formulated TDF/3TC/EFV(400mg) (Combo) [ Time Frame: week 4 ]
    The primary endpoint is the proportion of subjects achieving EFV concentration >1 mg/L at week 4.
Secondary Outcome Measures:
  • HIV-1 RNA load [ Time Frame: week 12 ]
    The secondary endpoints include the proportion of subjects with undetectable plasma HIV-1 RNA load (<50 copies/mL) at week 12
  • HIV-1 RNA load [ Time Frame: week 24 ]
    The secondary endpoints include the proportion of subjects with undetectable plasma HIV-1 RNA load (<50 copies/mL) at week 24
  • CD4+ T cell count [ Time Frame: week 12 ]
    The secondary endpoints include the proportion of subjects with CD4+ T cell count at week 12
  • CD4+ T cell count [ Time Frame: week 24 ]
    The secondary endpoints include the proportion of subjects with CD4+ T cell count at week 24.

Enrollment: 50
Study Start Date: December 6, 2018
Estimated Study Completion Date: December 31, 2019
Estimated Primary Completion Date: July 17, 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 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.
Drug: 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.

Other Name: non applicable

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.

Eligibility

Eligibility

Ages Eligible for Study: 20 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03595709

Locations

Taiwan
E-Da Hospital
Kaohsiung, Taiwan, 82445
National Taiwan University Hospital
Taipei, Taiwan

Sponsors and Collaborators

Yu-Jay Corp.

Investigators

Principal Investigator: Hsin-Yun Sun, MD National Taiwan University Hospital
More Information

More Information


Responsible Party: Yu-Jay Corp.  
ClinicalTrials.gov Identifier: NCT03595709   History of Changes  
Other Study ID Numbers: YJ14001-COMBO-201801  
Study First Received: July 2, 2018  
Last Updated: February 10, 2019  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Yu-Jay Corp.:

EFV
HIV Infections

Additional relevant MeSH terms:
HIV Infections
Lamivudine
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

ClinicalTrials.gov processed this data on October 16, 2019
This information is provided by ClinicalTrials.gov.