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Trial record 12 of 13 for:    midway IMMUNOLOGY research center | Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies

Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04223778
Recruitment Status : Active, not recruiting
First Posted : January 10, 2020
Last Update Posted : August 25, 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 protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) 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 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 578 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Antiretroviral Therapy
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: Immediate Switch to DOR/ISL
Participants receiving continuous antiretroviral therapy (ART) will switch to MK-8591A, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 96 weeks
Drug: DOR/ISL
A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily
Other Name: MK-8591A

Active Comparator: Baseline Regimen with Delayed Switch to DOR/ISL
Participants receiving continuous ART for 48 weeks will switch to MK-8591A, a FDC of 100 mg DOR/0.75 mg ISL for 48 weeks
Drug: DOR/ISL
A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily
Other Name: MK-8591A




Primary Outcome Measures :
  1. Participants with HIV-1 RNA ≥50 copies/mL [ Time Frame: Week 48 ]
    Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48

  2. Participants with one or more adverse events (AEs) up to Week 48 [ Time Frame: Day 1 to Week 48 ]
    Percentage of participants with one or more adverse events (AEs) up to Week 48

  3. Participants who discontinued study intervention up to Week 48 [ Time Frame: Day 1 to Week 48 ]
    Percentage of participants who discontinued study intervention due to an AE up to Week 48


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

  2. Participants with HIV-1 RNA ≥50 copies/mL, <40 copies/mL or <50 copies/mL [ Time Frame: Weeks 48 to 96 ]
    Percentage of participants with HIV-1 RNA ≥50 copies/mL, <40 copies/mL or <50 copies/mL from Week 48 to Week 96

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

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

  5. Change from baseline in 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. Change from Week 48 in CD4+ T-cell count at Week 96 [ Time Frame: Week 48 and Week 96 ]
    Change from Week 48 in CD4+ T-cell count at Week 96

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

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

  9. Change from baseline in fasting low-density lipoprotein cholesterol and nonhigh- density lipoprotein cholesterol to Week 24 [ Time Frame: Baseline and Week 24 ]
    Change from baseline in fasting low-density lipoprotein cholesterol and non-high- density lipoprotein cholesterol to Week 24

  10. Change from baseline in fasting low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol to Week 48 [ Time Frame: Baseline and Week 48 ]
    Change from baseline in fasting low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol to Week 48

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

  12. Participants with one or more AEs up to Week 96 [ Time Frame: Day 1 to Week 96 ]
    Percentage of participants with one or more AEs from Day 1 up to Week 96

  13. Participants who discontinued study intervention up to Week 96 [ Time Frame: Day 1 to Week 96 ]
    Percentage of participants who discontinued study intervention due to an AE from Day 1 up to Week 96

  14. Participants with one or more AEs from Week 48 up to Week 96 [ Time Frame: Weeks 48 to 96 ]
    Percentage of participants with one or more AEs from Week 48 up to Week 96

  15. Participants who discontinued study intervention from Week 48 up to Week 96 [ Time Frame: Weeks 48 to 96 ]
    Percentage of participants who discontinued study intervention due to an AE from Week 48 up to Week 96



Information from the National Library of Medicine

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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
  • Has been receiving continuous, stable oral 2-drug or 3-drug combination (± pharmacokinetic (PK) booster) 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 hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
  • 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 taking long-acting cabotegravir-rilpivirine
  • 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): NCT04223778


Locations
Show Show 78 study locations
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: NCT04223778    
Other Study ID Numbers: 8591A-017
2019-000586-20 ( EudraCT Number )
MK-8591A-017 ( Other Identifier: Merck )
205165 ( Registry Identifier: JAPIC-CTI )
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 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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Immunologic Deficiency Syndromes
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
4'-ethynyl-2-fluoro-2'-deoxyadenosine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents