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Showing 1–24 of 27 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Islatravir Clear all
Completed Phase 2 Interventional Results available

Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]

NCT04564547
View directory record Official record
Conditions
HIV-1 Infection
Interventions
Islatravir, Ulonivirine, BIC/FTC/TAF, Placebo to ISL, Placebo to Ulonivirine, Placebo to BIC/FTC/TAF
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
161 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
10
States / cities
Phoenix, Arizona • Los Angeles, California • Ft. Pierce, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Jan 25, 2026 · Synced Sep 3, 2026, 5:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Islatravir and Methadone Pharmacokinetics (MK-8591-029)

NCT04568603
View directory record Official record
Conditions
HIV-1 Infection
Interventions
Islatravir
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years to 65 Years
Enrollment
14 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2021
U.S. locations
2
States / cities
Hollywood, Florida • Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Jan 27, 2025 · Synced Sep 3, 2026, 5:32 AM EDT
Completed Phase 2 Interventional Results available

Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ≥35 kg (MK-8591A-028)

NCT04295772
View directory record Official record
Conditions
HIV-1 Infection
Interventions
DOR/ISL
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
Up to 17 Years
Enrollment
42 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
4
States / cities
Washington D.C., District of Columbia • Atlanta, Georgia • Baltimore, Maryland + 1 more
Source: ClinicalTrials.gov public record
Updated Jan 30, 2024 · Synced Sep 3, 2026, 5:32 AM EDT
Active, not recruiting Phase 3 Interventional Accepts healthy volunteers

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

NCT05705349
View directory record Official record
Conditions
HIV-1 Infection
Interventions
DOR/ISL, BIC/FTC/TAF, Placebo to DOR/ISL, Placebo to BIC/FTC/TAF
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
537 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2029
U.S. locations
38
States / cities
Phoenix, Arizona • Beverly Hills, California • Los Angeles, California + 29 more
Source: ClinicalTrials.gov public record
Updated Oct 22, 2025 · Synced Sep 3, 2026, 5:32 AM EDT
Active, not recruiting Phase 2 Interventional

A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060)

NCT06891066
View directory record Official record
Conditions
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Interventions
ISL, ULO, BIC/FTC/TAF
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2031
U.S. locations
11
States / cities
San Francisco, California • West Hollywood, California • Washington D.C., District of Columbia + 8 more
Source: ClinicalTrials.gov public record
Updated Oct 15, 2025 · Synced Sep 3, 2026, 5:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Clinical Study of Islatravir and Its Interaction With Lamivudine (MK-8591-058)

NCT06811246
View directory record Official record
Conditions
Healthy
Interventions
Islatravir (ISL), Lamivudine (3TC)
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years to 55 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024
U.S. locations
1
States / cities
Lincoln, Nebraska
Source: ClinicalTrials.gov public record
Updated Feb 5, 2025 · Synced Sep 3, 2026, 5:32 AM EDT
Completed Phase 3 Interventional Results available

Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)

NCT04233879
View directory record Official record
Conditions
HIV-1 Infection
Interventions
DOR/ISL, BIC/FTC/TAF, Placebo to BIC/FTC/TAF, Placebo to DOR/ISL
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
599 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
17
States / cities
Birmingham, Alabama • Phoenix, Arizona • Los Angeles, California + 14 more
Source: ClinicalTrials.gov public record
Updated Jun 2, 2026 · Synced Sep 3, 2026, 5:32 AM EDT
Active, not recruiting Phase 3 Interventional

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

NCT06630286
View directory record Official record
Conditions
HIV-1-infection
Interventions
ISL/LEN, B/F/TAF, PTM B/F/TAF, PTM ISL/LEN
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
609 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2030
U.S. locations
60
States / cities
Birmingham, Alabama • Phoenix, Arizona • Los Angeles, California + 50 more
Source: ClinicalTrials.gov public record
Updated Apr 29, 2026 · Synced Sep 3, 2026, 5:32 AM EDT
Active, not recruiting Phase 3 Interventional Results available

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)

NCT05630755
View directory record Official record
Conditions
HIV-1 Infection
Interventions
DOR/ISL, BIC/FTC/TAF, Placebo to BIC/FTC/TAF, Placebo to DOR/ISL
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
514 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
24
States / cities
Phoenix, Arizona • Beverly Hills, California • Los Angeles, California + 19 more
Source: ClinicalTrials.gov public record
Updated Nov 17, 2025 · Synced Sep 3, 2026, 5:32 AM EDT
Active, not recruiting Phase 3 Interventional

Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)

NCT04776252
View directory record Official record
Conditions
HIV-1 Infection
Interventions
MK-8591A
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
2,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2029
U.S. locations
18
States / cities
Phoenix, Arizona • Sacramento, California • Washington D.C., District of Columbia + 13 more
Source: ClinicalTrials.gov public record
Updated Dec 22, 2025 · Synced Sep 3, 2026, 5:32 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)

NCT04003103
View directory record Official record
Conditions
HIV-1 Infection
Interventions
Islatravir, Placebo
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years to 65 Years
Enrollment
242 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019 – 2022
U.S. locations
4
States / cities
Hollywood, Florida • Baltimore, Maryland • Lincoln, Nebraska + 1 more
Source: ClinicalTrials.gov public record
Updated Jul 17, 2025 · Synced Sep 3, 2026, 5:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026)

NCT04303156
View directory record Official record
Conditions
Human Immunodeficiency Virus (HIV) Infection
Interventions
Islatravir
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years to 75 Years
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Oct 27, 2021 · Synced Sep 3, 2026, 5:32 AM EDT
Terminated Phase 3 Interventional Accepts healthy volunteers Results available

Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024)

NCT04652700
View directory record Official record
Conditions
HIV Preexposure Prophylaxis
Interventions
ISL, FTC/TDF, FTC/TAF, Placebo to ISL, Placebo to FTC/TDF, Placebo to FTC/TAF
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
16 Years and older · Male only
Enrollment
494 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2023
U.S. locations
15
States / cities
Birmingham, Alabama • Los Angeles, California • San Francisco, California + 11 more
Source: ClinicalTrials.gov public record
Updated May 4, 2026 · Synced Sep 3, 2026, 5:32 AM EDT
Active, not recruiting Phase 3 Interventional Results available

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)

NCT05631093
View directory record Official record
Conditions
HIV-1 Infection
Interventions
ART, DOR/ISL
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
553 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
15
States / cities
Los Angeles, California • Palm Springs, California • San Francisco, California + 12 more
Source: ClinicalTrials.gov public record
Updated Nov 20, 2025 · Synced Sep 3, 2026, 5:32 AM EDT
Completed Phase 2 Interventional Results available

Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)

NCT03272347
View directory record Official record
Conditions
HIV-1 Infection
Interventions
Islatravir, Placebo to Islatravir, Doravirine, Placebo to Doravirine, Lamivudine, Placebo to Lamivudine, Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate, Placebo to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate, Doravirine/Islatravir
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
123 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
10
States / cities
Phoenix, Arizona • Sacramento, California • Washington D.C., District of Columbia + 7 more
Source: ClinicalTrials.gov public record
Updated Mar 28, 2023 · Synced Sep 3, 2026, 5:32 AM EDT
Active, not recruiting Phase 3 Interventional

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)

NCT05766501
View directory record Official record
Conditions
HIV Infection
Interventions
DOR/ISL
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
641 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
31
States / cities
Birmingham, Alabama • Phoenix, Arizona • Beverly Hills, California + 25 more
Source: ClinicalTrials.gov public record
Updated Dec 16, 2025 · Synced Sep 3, 2026, 5:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Single-Dose Islatravir in Moderate Hepatic Impairment (MK-8591-030)

NCT04515641
View directory record Official record
Conditions
Human Immunodeficiency Virus (HIV) Infection
Interventions
Islatravir
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years to 75 Years
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2021
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Jul 16, 2025 · Synced Sep 3, 2026, 5:32 AM EDT
Recruiting Phase 2Phase 3 Interventional

A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)

NCT07266831
View directory record Official record
Conditions
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Interventions
ISL, ULO, BIC/FTC/TAF, Placebo for BIC/FTC/TAF, Placebo to ISL/ULO, ISL/ULO
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
570 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
24
States / cities
Los Angeles, California • Denver, Colorado • Washington D.C., District of Columbia + 20 more
Source: ClinicalTrials.gov public record
Updated Aug 9, 2026 · Synced Sep 3, 2026, 5:32 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

NCT05052996
View directory record Official record
Conditions
HIV-1 Infection
Interventions
ISL, LEN, B/F/TAF, ISL/LEN FDC
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
142 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2028
U.S. locations
44
States / cities
Beverly Hills, California • Los Angeles, California • Newport Beach, California + 33 more
Source: ClinicalTrials.gov public record
Updated Feb 3, 2026 · Synced Sep 3, 2026, 5:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study of Doravirine/Islatravir in Healthy Lactating Females (MK-8591A-061)

NCT07086079
View directory record Official record
Conditions
Healthy
Interventions
DOR/ISL
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older · Female only
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2026
U.S. locations
1
States / cities
Springfield, Missouri
Source: ClinicalTrials.gov public record
Updated Feb 19, 2026 · Synced Sep 3, 2026, 5:32 AM EDT
Active, not recruiting Phase 3 Interventional

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

NCT06630299
View directory record Official record
Conditions
HIV-1-Infection
Interventions
ISL/LEN, Antiretroviral Combinations
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
600 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2030
U.S. locations
49
States / cities
Birmingham, Alabama • Phoenix, Arizona • Los Angeles, California + 41 more
Source: ClinicalTrials.gov public record
Updated May 28, 2026 · Synced Sep 3, 2026, 5:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study of MK-8507 and Islatravir (MK-8591) in Healthy Adult Participants (MK-8507-016)

NCT06619678
View directory record Official record
Conditions
Healthy
Interventions
MK-8507, Islatravir
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
19 Years to 65 Years
Enrollment
36 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024
U.S. locations
1
States / cities
Lincoln, Nebraska
Source: ClinicalTrials.gov public record
Updated Sep 30, 2024 · Synced Sep 3, 2026, 5:32 AM EDT
Completed Phase 3 Interventional Results available

Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)

NCT04223791
View directory record Official record
Conditions
HIV Infection
Interventions
DOR/ISL, BIC/FTC/TAF, Placebo to BIC/FTC/TAF, Placebo to FDC DOR/ISL
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
643 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
28
States / cities
Phoenix, Arizona • Beverly Hills, California • Los Angeles, California + 24 more
Source: ClinicalTrials.gov public record
Updated Mar 26, 2026 · Synced Sep 3, 2026, 5:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study of Doravirine and Islatravir as a Single Entity or Combination Therapy and the Effect of Food in Healthy Adult Participants (MK-8591A-055)

NCT06719570
View directory record Official record
Conditions
Healthy
Interventions
MK-8591A, Islatravir, Doravine
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
19 Years to 55 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024
U.S. locations
1
States / cities
Lincoln, Nebraska
Source: ClinicalTrials.gov public record
Updated Dec 5, 2024 · Synced Sep 3, 2026, 5:32 AM EDT