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ClinicalTrials.gov public records Last synced Sep 28, 2026, 12:18 AM EDT

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Showing 1–18 of 18 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Filters: Intervention: Doravirine 100 Mg 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 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 28, 2026, 12:18 AM EDT
Completed Early Phase 1 Interventional

Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV

NCT04820933
View directory record Official record
Conditions
HIV I Infection, Cardiovascular Risk Factor, Lipid Metabolism Disorders
Interventions
Doravirine 100 Mg
Drug
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years to 70 Years · Male only
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
2
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Jan 29, 2026 · Synced Sep 28, 2026, 12:18 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 28, 2026, 12:18 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 28, 2026, 12:18 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 28, 2026, 12:18 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 28, 2026, 12:18 AM EDT
Withdrawn Phase 3 Interventional Accepts healthy volunteers

Doravirine and Weight Gain in Antiretroviral Naive

NCT05457530
View directory record Official record
Conditions
Body Weight Changes, Human Immunodeficiency Virus, ART, Obesity, Minority Health, BMD, Metabolic Syndrome, Fasting
Interventions
DOR/3TC/TDF, DOR + FTC/TAF, BIC/FTC/TAF
Drug · Combination Product
Lead sponsor
Prism Health North Texas
Other
Eligibility
18 Years and older · Female only
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2023
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated May 11, 2023 · Synced Sep 28, 2026, 12:18 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 28, 2026, 12:18 AM EDT
Terminated No phase listed Observational Results available

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

NCT04518228
View directory record Official record
Conditions
HIV, Tuberculosis
Interventions
Bictegravir (BIC), Tenofovir alafenamide (TAF), Long-acting injectable formulation of cabotegravir (CAB LA), Dolutegravir (DTG), Atazanavir/ritonavir (ATV/r), Darunavir/ritonavir (DRV/r), Lopinavir/ritonavir (LPV/r), Cobicistat, Ritonavir, First-Line TB Treatment, Second-Line TB Treatment, Doravirine (DOR)
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
Not listed
Enrollment
205 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
13
States / cities
Los Angeles, California • San Diego, California • Aurora, Colorado + 7 more
Source: ClinicalTrials.gov public record
Updated Aug 25, 2026 · Synced Sep 28, 2026, 12:18 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 26, 2024 · Synced Sep 28, 2026, 12:18 AM EDT
Completed Phase 4 Interventional Results available

Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide

NCT04636437
View directory record Official record
Conditions
HIV Infections
Interventions
Doravirine 100 Mg, Integrase strand transfer inhibitors, Tenofovir alafenamide/emtricitabine, tenofovir disproxil fumarate/emtricitabine
Drug
Lead sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Network
Eligibility
18 Years and older
Enrollment
147 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
27
States / cities
Birmingham, Alabama • Los Angeles, California • San Diego, California + 21 more
Source: ClinicalTrials.gov public record
Updated Jul 1, 2025 · Synced Sep 28, 2026, 12:18 AM EDT
Recruiting Phase 2 Interventional

Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)

NCT04375800
View directory record Official record
Conditions
Human Immunodeficiency Virus (HIV) Infection
Interventions
Doravirine, 2 NRTIs, DOR/3TC/TDF
Drug
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Eligibility
4 Weeks to 11 Years
Enrollment
84 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2034
U.S. locations
2
States / cities
Aurora, Colorado • Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Jul 7, 2026 · Synced Sep 28, 2026, 12:18 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 28, 2026, 12:18 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 28, 2026, 12:18 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents

NCT03332095
View directory record Official record
Conditions
HIV Infections
Interventions
Doravirine (DOR), Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF), Antiretroviral (ARV) medications
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
12 Years to 17 Years
Enrollment
55 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
4
States / cities
Aurora, Colorado • Boston, Massachusetts • Memphis, Tennessee + 1 more
Source: ClinicalTrials.gov public record
Updated Feb 13, 2023 · Synced Sep 28, 2026, 12:18 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 28, 2026, 12:18 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 17, 2026 · Synced Sep 28, 2026, 12:18 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 28, 2026, 12:18 AM EDT