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DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

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ClinicalTrials.gov Identifier: NCT05705349
Recruitment Status : Recruiting
First Posted : January 30, 2023
Last Update Posted : May 6, 2024
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL [MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: DOR/ISL Drug: BIC/FTC/TAF Drug: Placebo to DOR/ISL Drug: Placebo to BIC/FTC/TAF Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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 the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants
Actual Study Start Date : March 8, 2023
Estimated Primary Completion Date : October 19, 2025
Estimated Study Completion Date : November 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Arms and Interventions
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Arm Intervention/treatment
Experimental: DOR/ISL
Participants take DOR/ISL and placebo to BIC/FTC/TAF once daily (qd) for 96 weeks.
 Drug: DOR/ISL
Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.
Other Name: MK-8591A

Drug: Placebo to BIC/FTC/TAF
Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth.
Active Comparator: BIC/FTC/TAF
Participants take BIC/FTC/TAF and placebo to DOR/ISL qd for 96 weeks.
 Drug: BIC/FTC/TAF
Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth.

Drug: Placebo to DOR/ISL
Placebo tablet matched to DOR/ISL tablet taken by mouth.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48 [ Time Frame: Week 48 ]
    Plasma HIV-1 RNA quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay with a lower limit of detection of <50 copies/mL.

  2. Percentage of participants experiencing ≥1 adverse event (AE) through Week 48 [ Time Frame: Up to 48 weeks ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  3. Percentage of participants discontinuing from study treatment due to an AE through Week 48 [ Time Frame: Up to 48 weeks ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.


Secondary Outcome Measures :
  1. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 [ Time Frame: Week 96 ]
    Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL.

  2. Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48 [ Time Frame: Week 48 ]
    Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL.

  3. Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96 [ Time Frame: Week 96 ]
    Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL.

  4. Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48 [ Time Frame: Baseline (Day 1) and Week 48 ]
    CD4+ T-cells are quantified with a T and B lymphocyte and natural killer cell (TBNK) panel.

  5. Change from baseline in CD4+ T-cells at Week 96 [ Time Frame: Baseline (Day 1) and Week 96 ]
    CD4+ T-cells are quantified with a TBNK panel.

  6. Incidence of viral drug resistance [ Time Frame: Up to 96 weeks ]
    Plasma samples will be collected for genotypic and phenotypic HIV-1 viral drug resistance testing and used to assess resistance-associated substitutions and viral susceptibility as applicable during the study.

  7. Change from baseline in body weight at Week 48 [ Time Frame: Baseline (Day 1) and Week 48 ]
    Body weight will be collected throughout the study.

  8. Change from baseline in body weight at Week 96 [ Time Frame: Baseline (Day 1) and Week 96 ]
    Body weight will be collected throughout the study.

  9. Percentage of participants experiencing ≥1 AE through Week 96 [ Time Frame: Up to 96 weeks ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  10. Percentage of participants discontinuing from study treatment due to an AE through Week 96 [ Time Frame: Up to 96 weeks ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Is HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL at screening
  • Is naïve to antiretroviral therapy (ART) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection
  • If female, is not a participant of childbearing potential (POCBP); or if a POCBP, is not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration

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 a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening
  • Has active hepatitis B infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA]-positive).
  • Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid [RNA]) and lab values are consistent with cirrhosis
  • Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
  • Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate
Contacts and Locations
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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): NCT05705349


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 LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Additional Information:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05705349    
Other Study ID Numbers: 8591A-053
2022-502099-22-00 ( Other Identifier: EU CT )
jRCT2031220720 ( Registry Identifier: jRCT )
First Posted: January 30, 2023    Key Record Dates
Last Update Posted: May 6, 2024
Last Verified: May 2024
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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Islatravir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents