Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate doravirine primarily for HIV-1 infection, encompassing treatment-naive regimens, switch strategies in virologically suppressed patients, and specialized cohorts such as pregnant women and bariatric surgery candidates. Sponsored by industry leaders like Merck Sharp & Dohme LLC alongside academic and foundation partners including Radboud University Medical Center and Chelsea and Westminster NHS Foundation Trust, these studies span recruiting, active, completed, and terminated statuses to evaluate parameters such as antiviral efficacy, tolerability, weight changes, and renal safety.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04776252 ACTIVE_NOT_RECRUITING
HIV-1 Infection
Merck Sharp & Dohme LLC
 2021-09-15 PHASE3
NCT04375800 RECRUITING
Human Immunodeficiency Virus (HIV) Infection
Merck Sharp & Dohme LLC
 2021-02-03 PHASE2
NCT05630638 RECRUITING
HIV
University of Liverpool
 2023-10-10 PHASE4
NCT07357584 NOT_YET_RECRUITING
HIV-1-infection
Fundación Huésped
 2026-07-13 PHASE4
NCT06203132 RECRUITING
HIV-1-infection
ANRS, Emerging Infectious Diseases
 2025-01-27 PHASE3
NCT07673965 NOT_YET_RECRUITING
HIV (Human Immunodeficiency Virus); Sleep
University of Witwatersrand, South Africa
 2026-08-20 PHASE4
NCT06774872 RECRUITING
HIV-1-infection
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
 2025-04-30 PHASE2
NCT04892654 RECRUITING
HIV-1-infection
Chelsea and Westminster NHS Foundation Trust
 2022-08-17 PHASE3
NCT07075146 RECRUITING
HIV - Human Immunodeficiency Virus; Obesity; Overweight and/or Obesity
José Antonio Mata Marín
 2025-05-05 PHASE3
NCT06034938 RECRUITING
Hiv
University Hospital, Caen
 2024-02-08 PHASE2
NCT06602622 RECRUITING
HIV; HIV Associate Weight Loss; HIV-1 Infection; Integrase Inhibitors, HIV; HIV PROTEASE INHIB; Weight Change; Weight Loss
Instituto Mexicano del Seguro Social
 2024-08-14 PHASE4
NCT04513626 RECRUITING
HIV Infections
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
 2020-09-15 PHASE2
NCT05766501 ACTIVE_NOT_RECRUITING
HIV Infection
Merck Sharp & Dohme LLC
 2023-03-17 PHASE3
NCT05705349 ACTIVE_NOT_RECRUITING
HIV-1 Infection
Merck Sharp & Dohme LLC
 2023-03-08 PHASE3
NCT04820933 COMPLETED
HIV I Infection; Cardiovascular Risk Factor; Lipid Metabolism Disorders
University of Texas Southwestern Medical Center
 2024-03-01 EARLY_PHASE1
NCT04900974 COMPLETED
HIV Infections; Pregnancy Related
University of North Carolina, Chapel Hill
 2022-06-09 PHASE1
NCT05506605 UNKNOWN
HIV-1-infection
Fundacion Clinic per a la Recerca Biomédica
 2022-12-12 PHASE4
NCT05289986 TERMINATED
Hiv
Chelsea and Westminster NHS Foundation Trust
 2023-11-21 PHASE4
NCT05648201 COMPLETED
Hiv
Radboud University Medical Center
 2023-03-01 PHASE4
NCT05630755 ACTIVE_NOT_RECRUITING
HIV-1 Infection
Merck Sharp & Dohme LLC
 2023-02-17 PHASE3
NCT04636437 COMPLETED
HIV Infections
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2021-07-27 PHASE4
NCT05631093 ACTIVE_NOT_RECRUITING
HIV-1 Infection
Merck Sharp & Dohme LLC
 2023-02-20 PHASE3
NCT04665375 TERMINATED
Hiv; Weight Gain
University Health Network, Toronto
 2021-04-26 PHASE4
NCT06719570 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2024-01-23 PHASE1
NCT05477407 COMPLETED
HIV Infections
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
 2022-10-06
NCT04669678 COMPLETED
HIV Infections; Contraception; Drug-drug Interaction
University of Alabama at Birmingham
 2021-11-17 PHASE4
NCT06155019 Recruiting
HIV Infections
Centre de Recherches et d''Etude sur la Pathologie Tropicale et le Sida
 2023-12-15 --
NCT05630638 Recruiting
HIV
University of Liverpool|Liverpool School of Tropical Medicine|Desmond Tutu Health Foundation
 2023-10-10 Phase 4
NCT04429152 UNKNOWN
HIV-1-infection
Professor Francois Venter
 2021-02-09 PHASE3
NCT05536466 UNKNOWN
HIV Infections; Bariatric Surgery Candidate
Radboud University Medical Center
 2022-09-30
NCT05761509 Active not recruiting
HIV Infections
Institut de Médecine et d''Epidémiologie Appliquée - Fondation Internationale Léon M''Ba|Merck Sharp & Dohme LLC
 2023-06-08 --
NCT04433780 COMPLETED
HIV-1-infection
Professor Francois Venter
 2021-01-04 PHASE3
NCT04903847 UNKNOWN
Hiv; HIV Infections; HIV Lipodystrophy; Osteoporosis; Renal Insufficiency; Weight Gain; Obesity
Thomas Benfield
 2021-02-02 PHASE4
NCT04233216 COMPLETED
HIV-1 Infection
Merck Sharp & Dohme LLC
 2020-03-18 PHASE3
NCT04233879 COMPLETED
HIV-1 Infection
Merck Sharp & Dohme LLC
 2020-02-28 PHASE3
NCT04283656 COMPLETED
Transgender Health; Gender Dysphoria; Transgender Women; Human Immunodeficiency Virus
Thomas Jefferson University
 2022-01-04 PHASE1
NCT05536466 Not yet recruiting
HIV Infections|Bariatric Surgery Candidate
Radboud University Medical Center
 2022-09-30 Not Applicable
NCT04233372 COMPLETED
Hiv
Hospital Clinic of Barcelona
 2020-08-27 PHASE4
NCT04334551 UNKNOWN
HIV Infections
Clinique du Quartier Latin
 2020-06-23 PHASE4
NCT04900974 Recruiting
HIV Infections|Pregnancy Related
University of North Carolina Chapel Hill|Merck Sharp & Dohme LLC
 2022-06-09 Phase 1
NCT04295772 COMPLETED
HIV-1 Infection
Merck Sharp & Dohme LLC
 2020-11-26 PHASE2
NCT04538040 COMPLETED
HIV-1-infection
Quest Clinical Research
 2019-12-19 PHASE4
NCT04223778 COMPLETED
HIV Infection
Merck Sharp & Dohme LLC
 2020-02-18 PHASE3
NCT04223791 COMPLETED
HIV Infection
Merck Sharp & Dohme LLC
 2020-02-18 PHASE3
NCT04689737 COMPLETED
HIV-infected Participants With ESRD Undergoing Routine Hemodialysis
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2021-03-20 PHASE4
NCT03272347 COMPLETED
HIV-1 Infection
Merck Sharp & Dohme LLC
 2017-11-27 PHASE2
NCT04079452 COMPLETED
HIV-1-infection
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2020-02-18 PHASE3
NCT04097925 COMPLETED
HIV-1-infection
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2020-02-18 PHASE2
NCT03332095 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2018-07-02 PHASE1; PHASE2
NCT03894124 COMPLETED
Human Immunodeficiency Virus
Chelsea and Westminster NHS Foundation Trust
 2019-06-12 PHASE1
NCT03886701 COMPLETED
Latent Tuberculosis; Human Immunodeficiency Virus; Rifamycins Causing Adverse Effects in Therapeutic Use; Drug Interaction Potentiation
Walter K. Kraft
 2019-04-22 PHASE1
NCT02629822 COMPLETED
HIV-1 Infection
Merck Sharp & Dohme LLC
 2016-01-14 PHASE2
NCT02652260 COMPLETED
HIV-1; Central Nervous System
Merck Sharp & Dohme LLC
 2016-03-04 PHASE2
NCT02397096 COMPLETED
HIV-1 Infection
Merck Sharp & Dohme LLC
 2015-06-09 PHASE3
NCT02403674 COMPLETED
Human Immunodeficiency Virus (HIV)
Merck Sharp & Dohme LLC
 2015-06-05 PHASE3
NCT02275780 COMPLETED
HIV-1
Merck Sharp & Dohme LLC
 2014-12-01 PHASE3
NCT02715700 COMPLETED
Human Immunodeficiency Virus (HIV) Infection
Merck Sharp & Dohme LLC
 2015-09-28 PHASE1
NCT02641067 COMPLETED
Renal Impairment
Merck Sharp & Dohme LLC
 2016-01-26 PHASE1
NCT02549040 COMPLETED
Human Immunodeficiency Virus-1 (HIV-1)
Merck Sharp & Dohme LLC
 2015-09-21 PHASE1
NCT01632345 COMPLETED
HIV Infections
Merck Sharp & Dohme LLC
 2012-10-12 PHASE2
NCT02089659 COMPLETED
HIV-1 Infection
Merck Sharp & Dohme LLC
 2014-03-26 PHASE1
NCT01466985 COMPLETED
HIV-1 Infection
Merck Sharp & Dohme LLC
 2011-10-21 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-12-23)

Check the Doravirine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Doravirine is a highly specific nonnucleoside reverse transcriptase inhibitor that binds to HIV-1 reverse transcriptase, inhibiting viral RNA-dependent DNA polymerase activity with IC50 values of 12 nM against wild-type virus and 9.7 nM against K103N and Y181C mutant strains. By disrupting reverse transcription and blocking viral replication, doravirine facilitates sustained viral suppression and clinical improvement in individuals with HIV-1 infection.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.