Doravirine

Generic Name
Doravirine
Brand Names
Delstrigo, Pifeltro
Drug Type
Small Molecule
Chemical Formula
C17H11ClF3N5O3
CAS Number
1338225-97-0
Unique Ingredient Identifier
913P6LK81M
Background

Doravirine is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) intended to be administered in combination with other antiretroviral medicines. Doravirine is available by itself or as a combination product of doravirine (100 mg), lamivudine (300 mg), and tenofovir disoproxil fumarate (300 mg).
...

Indication

Doravirine is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history. It is also indicated to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen ...

Associated Conditions
Human Immunodeficiency Virus Type 1 (HIV-1), Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Associated Therapies
-
Clinical Trials
Related News

Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals

Phase 2
Completed
Conditions
HIV-1-infection
Interventions
Drug: Doravirine
Drug: Descovy
First Posted Date
2019-09-20
Last Posted Date
2022-07-06
Lead Sponsor
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Target Recruit Count
30
Registration Number
NCT04097925
Locations
🇪🇸

Hospital Universitari de Bellvitge, L'Hospitalet De Llobregat, Barcelona, Spain

Doravirine Concentrations and Antiviral Activity in Cerebrospinal Fluid in HIV-1 Infected Individuals

Phase 3
Completed
Conditions
HIV-1-infection
Interventions
Drug: Doravirine
Drug: Descovy
First Posted Date
2019-09-06
Last Posted Date
2022-04-28
Lead Sponsor
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Target Recruit Count
15
Registration Number
NCT04079452
Locations
🇪🇸

Hospital Universitari de Bellvitge, L'Hospitalet De Llobregat, Barcelona, Spain

Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers

Phase 1
Completed
Conditions
Human Immunodeficiency Virus
Interventions
Drug: Doravirine
First Posted Date
2019-03-28
Last Posted Date
2019-08-12
Lead Sponsor
Chelsea and Westminster NHS Foundation Trust
Target Recruit Count
14
Registration Number
NCT03894124
Locations
🇬🇧

Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom

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

First Posted Date
2017-09-05
Last Posted Date
2023-03-29
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
123
Registration Number
NCT03272347
Locations
🇺🇸

North Texas Infectious Diseases Consultants, PA ( Site 0103), Dallas, Texas, United States

🇺🇸

Whitman Walker Clinic ( Site 0108), Washington, District of Columbia, United States

🇺🇸

Orlando Immunology Center (OIC) ( Site 0105), Orlando, Florida, United States

and more 23 locations

Effects of Doravirine (MK-1439) on Methadone Pharmacokinetics in Methadone-Maintained Participants (MK-1439-045)

First Posted Date
2016-03-22
Last Posted Date
2019-06-25
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
14
Registration Number
NCT02715700

A Study Evaluating the Pharmacokinetics of Doravirine (MK-1439) in Participants With Severe Renal Impairment (MK-1439-051)

Phase 1
Completed
Conditions
Renal Impairment
Interventions
Drug: Doravirine
First Posted Date
2015-12-29
Last Posted Date
2019-02-08
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
16
Registration Number
NCT02641067

Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)

First Posted Date
2014-10-27
Last Posted Date
2024-10-01
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
769
Registration Number
NCT02275780

A Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Doravirine (MK-1439) (MK-1439-019)

Phase 1
Completed
Conditions
HIV-1 Infection
Interventions
Drug: Doravirine
First Posted Date
2014-03-18
Last Posted Date
2018-12-28
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
16
Registration Number
NCT02089659

A Dose-Ranging Study to Compare Doravirine (MK-1439) Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007)

First Posted Date
2012-07-02
Last Posted Date
2019-07-18
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
342
Registration Number
NCT01632345

A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005)

Phase 1
Completed
Conditions
HIV-1 Infection
Interventions
Drug: Doravirine
Drug: Placebo
First Posted Date
2011-11-08
Last Posted Date
2019-02-15
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
18
Registration Number
NCT01466985
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