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Trial record 1 of 1 for:    8591a-018
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Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)

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ClinicalTrials.gov Identifier: NCT04223791
Recruitment Status : Recruiting
First Posted : January 10, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: DOR/ISL Drug: BIC/FTC/TAF Drug: Placebo to BIC/FTC/TAF Drug: Placebo to FDC DOR/ISL Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 578 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV- 1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
Actual Study Start Date : February 18, 2020
Estimated Primary Completion Date : October 15, 2021
Estimated Study Completion Date : September 16, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: DOR/ISL
A fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 96 weeks; and placebo to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) for 96 weeks
Drug: DOR/ISL
100 mg DOR/ 0.75 ISL FDC tablet taken orally once daily
Other Name: MK-8591A

Drug: Placebo to BIC/FTC/TAF
Placebo to BIC/FTC/TAF in a single tablet taken orally, once daily

Active Comparator: BIC/FTC/TAF
50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 96 weeks, and placebo to FDC DOR/ISL for 96 weeks
Drug: BIC/FTC/TAF
50 mg BIC, 200 mg FTC, and 25 mg TAF combined in a single tablet, taken orally once daily

Drug: Placebo to FDC DOR/ISL
Placebo to FDC DOR/ISL in a tablet taken orally, once daily
Other Name: Placebo to MK-8591A




Primary Outcome Measures :
  1. Participants with (Human Immunodeficiency Virus 1 ribonucleic acid ) HIV-1 RNA ≥50 copies/mL at Week 48 [ Time Frame: Week 48 ]
    Percentage of participants with (Human Immunodeficiency Virus 1 ribonucleic acid) HIV-1 RNA ≥50 copies/mL at Week 48

  2. Participants with one or more adverse events (AEs) up to Week 48 [ Time Frame: Up to 48 weeks ]
    Percentage of participants with one or more adverse events (AEs) up to Week 48

  3. Participants who discontinued study intervention due to an AE up to Week 48 [ Time Frame: Up to 48 weeks ]
    Percentage of participants who discontinued study intervention due to an AE up to Week 48


Secondary Outcome Measures :
  1. Participants with HIV-1 RNA ≥50 copies/mL at Week 96 [ Time Frame: Week 96 ]
    Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96

  2. Participants with HIV-1 RNA <40 or <50 copies/mL at Week 48 [ Time Frame: Week 48 ]
    Percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 48

  3. Participants with HIV-1 RNA <40 or <50 copies/mL at Week 96 [ Time Frame: Week 96 ]
    Percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 96

  4. CD4+ T-cell count at Week 48 [ Time Frame: Baseline and Week 48 ]
    Change from baseline in CD4+ T-cell count at Week 48

  5. CD4+ T-cell count at Week 96 [ Time Frame: Baseline and Week 96 ]
    Change from baseline in CD4+ T-cell count at Week 96

  6. Participants with evidence of viral drug resistance-associated substitutions at Week 48 [ Time Frame: Week 48 ]
    Percentage participants with evidence of viral drug resistance-associated substitutions at Week 48

  7. Participants with evidence of viral drug resistance-associated substitutions at Week 96 [ Time Frame: Week 96 ]
    Percentage participants with evidence of viral drug resistance-associated substitutions at Week 96

  8. Change from baseline in body weight at Week 48 [ Time Frame: Baseline and Week 48 ]
    Change from baseline in body weight at Week 48

  9. Change from baseline in body weight at Week 96 [ Time Frame: Baseline and Week 96 ]
    Change from baseline in body weight at Week 96

  10. Participants with one or more AEs up to Week 96 [ Time Frame: Up to Week 96 ]
    Percentage of participants with one or more AEs up to Week 96

  11. Participants who discontinued study intervention due to an AE up to Week 96 [ Time Frame: Up to Week 96 ]
    Percentage of participants who discontinued study intervention due to an AE up to Week 96



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is HIV-1 positive with plasma (Human Immunodeficiency Virus 1) HIV-1 RNA <50 copies/mL at screening.
  • Has been receiving BIC/FTC/TAF therapy with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen.
  • Female is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive;

Exclusion Criteria:

  • Has HIV-2 infection
  • Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection
  • Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
  • Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies
  • Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period.
  • Has a documented or known virologic resistance to DOR,
  • Female expects to conceive or donate eggs at any time during the study

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): NCT04223791


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT04223791    
Other Study ID Numbers: 8591A-018
2019-000587-23 ( EudraCT Number )
MK-8591A-018 ( Other Identifier: Merck )
205166 ( Registry Identifier: JAPIC-CTI )
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
4'-ethynyl-2-fluoro-2'-deoxyadenosine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents