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)

Phase 3

Active, not recruiting

• Conditions: HIV Infection
• Interventions: Drug: DOR/ISL

• Registration Number: NCT05766501
• Lead Sponsor: Merck Sharp & Dohme LLC

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 available

Study Timeline

• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-01
• Study First Posted: 2023-03-13
• Study Start: 2023-03-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08
• Primary Completion: 2025-12-03
• Study Completion: 2028-09-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 650

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DOR/ISL	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. After Week 96, eligible participants may continue on DOR/ISL until week 240 or until DOR/ISL becomes commercially accessible, whichever comes first.

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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.
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.
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
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.

Trial Locations

Locations (95)

University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104); 🇺🇸 Birmingham, Alabama, United States

Pueblo Family Physicians ( Site 3102); 🇺🇸 Phoenix, Arizona, United States

Pacific Oaks Medical Group ( Site 3123); 🇺🇸 Beverly Hills, California, United States

Kaiser Permanente ( Site 3124); 🇺🇸 Los Angeles, California, United States

Ruane Clinical Research Group, Inc ( Site 3126); 🇺🇸 Los Angeles, California, United States

Mills Clinical Research ( Site 3114); 🇺🇸 Los Angeles, California, United States

University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137); 🇺🇸 Sacramento, California, United States

Georgetown University Medical Center ( Site 3130); 🇺🇸 Washington, District of Columbia, United States

Therafirst Medical Center ( Site 3110); 🇺🇸 Fort Lauderdale, Florida, United States

Midway Immunology and Research Center ( Site 3117); 🇺🇸 Fort Pierce, Florida, United States

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