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A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05766501
Collaborator
(none)
1,300
Enrollment
1
Arm
33.5
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study
Anticipated Study Start Date :
Mar 30, 2023
Anticipated Primary Completion Date :
Jan 14, 2026
Anticipated Study Completion Date :
Jan 14, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: DOR/ISL

Participants will receive fixed dose combination (FDC) tablet of DOR/ISL (100 mg/0.25 mg) taken once daily (QD) orally from Day 1 to Week 96.

Drug: DOR/ISL
FDC tablet of DOR/ISL (100 mg/ 0.25 mg) taken once daily
Other Names:
  • MK-8591A

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with One or More Adverse Event (AE) [Up to 102 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE through Week 102 will be presented.

    2. Percentage of participants who Discontinue Study Intervention Due to an AE [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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE through Week 96 will be presented.

    Secondary Outcome Measures

    1. Percentage of Participants with HIV-1 Ribonucleic Acid (RNA) ≥50 copies/mL at Week 96 [Week 96]

      The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 will be reported.

    2. Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96 [Week 96]

      The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 will be reported.

    3. Percentage of Participants with HIV-1 RNA ≥200 copies/mL at Week 96 [Week 96]

      The percentage of participants with HIV-1 RNA ≥200 copies/mL at Week 96 will be reported

    4. Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions [Up to Week 96]

      Viral drug resistance is defined as participants with HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic data showing evidence of resistance to the study intervention. The percentage of participants who demonstrate drug resistance through Week 96 will be presented.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp & Dohme (MSD)-sponsored clinical studies (MK-8591A-017, -018, -020, and -033 [except for heavily treatment-experienced (HTE) participants]).
    Exclusion Criteria:

    • Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-017 /-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033.

    • Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL.

    • Is a HTE participant receiving treatment in MK-8591A-019 or -033.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT05766501
    Other Study ID Numbers:
    • 8591A-054
    • MK-8591A-054
    • 2022-502126-40-00
    First Posted:
    Mar 13, 2023
    Last Update Posted:
    Mar 13, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Islatravir

    Study Results

    No Results Posted as of Mar 13, 2023