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

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ClinicalTrials.gov Identifier: NCT03595709
Recruitment Status : Active, not recruiting
First Posted : July 23, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Yu-Jay Corp.

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

Condition or disease Intervention/treatment Phase
HIV Infections Drug: 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Actual Study Start Date : December 6, 2018
Estimated Primary Completion Date : July 17, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. CD4+ T cell count [ Time Frame: week 12 ]
    The secondary endpoints include the proportion of subjects with CD4+ T cell count at week 12

  4. CD4+ T cell count [ Time Frame: week 24 ]
    The secondary endpoints include the proportion of subjects with CD4+ T cell count at week 24.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595709


Locations
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Taiwan
E-Da Hospital
Kaohsiung, Taiwan, 82445
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
Yu-Jay Corp.
Investigators
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Principal Investigator: Hsin-Yun Sun, MD National Taiwan University Hospital

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Responsible Party: Yu-Jay Corp.
ClinicalTrials.gov Identifier: NCT03595709     History of Changes
Other Study ID Numbers: YJ14001-COMBO-201801
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Lamivudine
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents