Doravirine

Generic Name: Doravirine

Brand Names: Delstrigo, Pifeltro

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₁₁ClF_₃N_₅O_₃

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).

Doravirine is formally indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, further expanding the possibility and choice of therapeutic treatments available for the management of HIV-1 infection.

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 with no history of treatment failure and no known substitutions associated with resistance to doravirine.

Associated Conditions: Human Immunodeficiency Virus Type 1 (HIV-1), Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Associated Therapies: -

Clinical Trials

"Observational Study on Tolerability and Observance of Post-exposure Prophylaxis With Doravirine in HIV Viral Risk"

Completed

Conditions: HIV Infections

Interventions: Drug: Doravirine

First Posted Date: 2023-03-09

Last Posted Date: 2024-10-07

Lead Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Target Recruit Count: 226

Registration Number: NCT05761509

Locations: 🇫🇷
Service de maladies infectieuses et tropicales de de l'hôpital La Pitié-Salpêtrière, Paris, France
🇫🇷
Service de maladies infectieuses et tropicales du CHU de Montpellier, Montpellier, France
🇫🇷
Hopital Saint Antoine, Paris, France

Doravirine Dose Optimisation in Pregnancy

Phase 4

Recruiting

Conditions: HIV

Interventions: Drug: Doravirine
Drug: Dolutegravir

First Posted Date: 2022-11-29

Last Posted Date: 2024-12-09

Lead Sponsor: University of Liverpool

Target Recruit Count: 76

Registration Number: NCT05630638

Locations: 🇿🇦
Desmond Tutu Health Foundation, Cape Town, South Africa

HIV A6 Genome In ART Unsuccessful Patients On DOR

Conditions: Virus-HIV

Interventions: Drug: Doravirine

First Posted Date: 2022-04-11

Last Posted Date: 2022-04-11

Lead Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Target Recruit Count: 60

Registration Number: NCT05322083

Non-Interventional Observational Retrospective Study to Evaluate Doravirine Based-regimens in HIV Infected Aged Patients (DORAge).

Conditions: HIV

Interventions: Drug: Doravirine

First Posted Date: 2022-01-21

Last Posted Date: 2022-01-21

Lead Sponsor: University of Roma La Sapienza

Target Recruit Count: 90

Registration Number: NCT05202613

Locations: 🇮🇹
Department of Public Health and Infectious Diseases, Rome, Italy/RM, Italy

Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women

Phase 1

Recruiting

Conditions: HIV Infections
Pregnancy Related

Interventions: Drug: Doravirine

First Posted Date: 2021-05-25

Last Posted Date: 2024-08-26

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 10

Registration Number: NCT04900974

Locations: 🇺🇸
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch

Phase 3

Recruiting

Conditions: HIV-1-infection

Interventions: Drug: Doravirine
Drug: Dolutegravir
Other: Triple cART regimen

First Posted Date: 2021-05-19

Last Posted Date: 2023-10-25

Lead Sponsor: Chelsea and Westminster NHS Foundation Trust

Target Recruit Count: 150

Registration Number: NCT04892654

Locations: 🇬🇧
Mortimer Market Centre, London, United Kingdom
🇬🇧
Imperial College Healthcare NHS Trust, London, United Kingdom
🇬🇧
Chelsea & Westminster Hospital NHS Foundation Trust, London, United Kingdom

Removal of Doravirine by Hemodialysis in HIV-Infected Patients With End-stage Renal Disease (ESRD)

Phase 4

Completed

Conditions: HIV-infected Participants With ESRD Undergoing Routine Hemodialysis

Interventions: Drug: Doravirine

First Posted Date: 2020-12-30

Last Posted Date: 2024-08-27

Lead Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Target Recruit Count: 8

Registration Number: NCT04689737

Locations: 🇪🇸
Universitario Bellvitge Hospital, Hospitalet de Llobregat, Barcelona, Spain
🇪🇸
Germans Trias i Pujol Hospital, Badalona, Barcelona, Spain
🇪🇸
Valle Hebron Hospital, Barcelona, Spain

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

Recruiting

Conditions: Tuberculosis
HIV Infections

Interventions: Drug: Bictegravir (BIC)
Drug: Doravirine (DOR)
Drug: Tenofovir alafenamide (TAF)
Drug: Cabotegravir (CAB)
Drug: Atazanavir/ritonavir (ATV/r)
Drug: Lopinavir/ritonavir (LPV/r)
Drug: Second-Line TB Treatment
Drug: Dolutegravir (DTG)
Drug: Cobicistat
Drug: First-Line TB Treatment
Drug: Darunavir/ritonavir (DRV/r)
Drug: Ritonavir

First Posted Date: 2020-08-19

Last Posted Date: 2024-08-21

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 325

Registration Number: NCT04518228

Locations: 🇺🇸
Emory University School of Medicine NICHD CRS, Atlanta, Georgia, United States
🇺🇸
Johns Hopkins Univ. Baltimore NICHD CRS, Baltimore, Maryland, United States
🇿🇦
Wits RHI Shandukani Research, Johannesburg, Gauteng, South Africa

and more 34 locations