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)

• ClinicalTrials.gov Identifier: NCT05766501
• Recruitment Status: Active, not recruiting
• First Posted: March 13, 2023
• Last Update Posted: January 5, 2024
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Tracking Information

• First Submitted Date: March 1, 2023
• First Posted Date: March 13, 2023
• Last Update Posted Date: January 5, 2024
• Actual Study Start Date: March 17, 2023
• Estimated Primary Completion Date: January 14, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 1, 2023)

• Percentage of Participants with One or More Adverse Event (AE) [ Time Frame: 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.
• Percentage of participants who Discontinue Study Intervention Due to an AE [ 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. 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 1, 2023)

• Percentage of Participants with HIV-1 Ribonucleic Acid (RNA) ≥50 copies/mL at Week 96 [ Time Frame: Week 96 ]
  The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 will be reported.
• Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96 [ Time Frame: Week 96 ]
  The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 will be reported.
• Percentage of Participants with HIV-1 RNA ≥200 copies/mL at Week 96 [ Time Frame: Week 96 ]
  The percentage of participants with HIV-1 RNA ≥200 copies/mL at Week 96 will be reported
• Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: HIV Infection

Intervention

Drug: DOR/ISL

FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily

Other Names:

• MK-8591A
• Doravirine/islatravir

Study Arms

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.

Intervention: Drug: DOR/ISL

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: November 14, 2023): 650
• Original Estimated Enrollment (submitted: March 1, 2023): 1300
• Estimated Study Completion Date: January 14, 2026
• Estimated Primary Completion Date: January 14, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Canada, Chile, Colombia, Israel, Japan, New Zealand, Puerto Rico, Russian Federation, South Africa, Switzerland, Taiwan, United Kingdom, United States

Administrative Information

• NCT Number: NCT05766501
• Other Study ID Numbers: 8591A-054; MK-8591A-054 ( Other Identifier: Merck ); 2022-502126-40-00 ( Registry Identifier: EU CT ); jRCT2051230002 ( Registry Identifier: jRCT )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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

• Current Responsible Party: Merck Sharp & Dohme LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Merck Sharp & Dohme LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Merck Sharp & Dohme LLC
• Verification Date: January 2024