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ClinicalTrials.gov public records Last synced Oct 19, 2026, 10:14 AM EDT

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Showing 1–24 of 28 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Islatravir Clear all
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 18, 2025 · Synced Oct 19, 2026, 10:14 AM EDT
Completed Phase 3 Interventional Results available

Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)

NCT04223778
View directory record Official record
Conditions
HIV Infection
Interventions
DOR/ISL, ART
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
18 Years and older
Enrollment
672 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
15
States / cities
Washington D.C., District of Columbia • Ft. Pierce, Florida • Orlando, Florida + 11 more
Source: ClinicalTrials.gov public record
Updated Feb 18, 2026 · Synced Oct 19, 2026, 10:14 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 29, 2026 · Synced Oct 19, 2026, 10:14 AM EDT
Not yet recruiting Phase 2 Interventional

Effects of Switch to Doravirine/Islatravir vs. Continued Antiretroviral Therapy on Biomarkers of Aging Among Virologically Suppressed People With HIV

NCT07871552
View directory record Official record
Conditions
Epigenetic Aging
Interventions
Switch from an ART regimen containing lamivudine (3TC) or emtricitabine (FTC) + tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) to DOR/ISL, Switch from an nucleoside reverse transcriptase inhibitor (NRTI)-sparing ART regimen containing greater than or equal to 2 drugs to DOR/ISL, Continue SoC ART
Drug
Lead sponsor
The University of Texas Health Science Center, Houston
Other
Eligibility
35 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
2
States / cities
Aurora, Colorado • Houston, Texas
Source: ClinicalTrials.gov public record
Updated Oct 13, 2026 · Synced Oct 19, 2026, 10:14 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 31, 2024 · Synced Oct 19, 2026, 10:14 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 21, 2025 · Synced Oct 19, 2026, 10:14 AM EDT
Terminated Phase 3 Interventional Accepts healthy volunteers Results available

Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)

NCT04644029
View directory record Official record
Conditions
HIV-I, Human Immunodeficiency Virus Type 1, Prophylaxis
Interventions
Islatravir, Placebo to FTC/TDF, FTC/TDF, Placebo to ISL
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
16 Years to 45 Years · Female only
Enrollment
730 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2024
U.S. locations
13
States / cities
Birmingham, Alabama • Washington D.C., District of Columbia • Miami, Florida + 10 more
Source: ClinicalTrials.gov public record
Updated Feb 4, 2026 · Synced Oct 19, 2026, 10:14 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 5, 2026 · Synced Oct 19, 2026, 10:14 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 16, 2025 · Synced Oct 19, 2026, 10:14 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 18, 2025 · Synced Oct 19, 2026, 10:14 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 3, 2026 · Synced Oct 19, 2026, 10:14 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 17, 2025 · Synced Oct 19, 2026, 10:14 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 28, 2025 · Synced Oct 19, 2026, 10:14 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 23, 2025 · Synced Oct 19, 2026, 10:14 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 6, 2024 · Synced Oct 19, 2026, 10:14 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 6, 2025 · Synced Oct 19, 2026, 10:14 AM EDT
Completed Phase 3 Interventional Results available

Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)

NCT04233216
View directory record Official record
Conditions
HIV-1 Infection
Interventions
ISL, DOR, DOR/ISL, Placebo to ISL, Placebo to DOR
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
Not listed
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
19
States / cities
Birmingham, Alabama • Los Angeles, California • Palm Springs, California + 15 more
Source: ClinicalTrials.gov public record
Updated Dec 27, 2024 · Synced Oct 19, 2026, 10:14 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 30, 2026 · Synced Oct 19, 2026, 10:14 AM EDT
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 26, 2026 · Synced Oct 19, 2026, 10:14 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 17, 2025 · Synced Oct 19, 2026, 10:14 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 29, 2023 · Synced Oct 19, 2026, 10:14 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 20, 2026 · Synced Oct 19, 2026, 10:14 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 Oct 1, 2024 · Synced Oct 19, 2026, 10:14 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 28, 2021 · Synced Oct 19, 2026, 10:14 AM EDT