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Last Updated: April 12, 2024

CLINICAL TRIALS PROFILE FOR DORAVIRINE


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All Clinical Trials for Doravirine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01466985 ↗ A Study of Doravirine (MK-1439) in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439-005) Completed Merck Sharp & Dohme Corp. Phase 1 2011-10-21 This is a study to evaluate the safety, tolerability, pharmacokinetics, and antiretroviral activity of doravirine (MK-1439) as monotherapy in antiretroviral therapy (ART)-naïve, HIV-1-infected participants.
NCT01632345 ↗ 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) Completed Merck Sharp & Dohme Corp. Phase 2 2012-10-12 The hypothesis tested in this study is that doravirine (MK-1439) at the final dose selected is superior to efavirenz, each given in combination with TRUVADA®, as measured by the percentage of participants with CNS events by Week 8. If superiority is established at Week 8, the same hypothesis will be tested for Week 24.
NCT02089659 ↗ A Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Doravirine (MK-1439) (MK-1439-019) Completed Merck Sharp & Dohme Corp. Phase 1 2014-03-26 This study aimed to investigate the influence of hepatic insufficiency on the pharmacokinetics (PK) of doravirine (MK-1439). In Part 1, PK of doravirine in participants with moderate hepatic insufficiency was compared with that of healthy control subjects matched with regard to mean age and weight. If a clinically meaningful increase in exposure of doravirine was observed in participants with moderate hepatic insufficiency in Part 1, study Part 2 was to evaluate PK of doravirine in participants with mild hepatic insufficiency.
NCT02275780 ↗ Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018) Active, not recruiting Merck Sharp & Dohme Corp. Phase 3 2014-12-01 To establish a new treatment option for treatment-naïve participants with HIV-1, the efficacy and safety of doravirine will be determined relative to a protease inhibitor (PI). Participants will receive double-blind treatment during the 96-week Base Study. Eligible participants in either of the Base Study groups will continue to receive the doravirine-containing regimen open label for an additional 96 weeks in the Study Extension 1. Eligible participants who are deriving benefit will continue in Study Extension 2 to receive the doravirine-containing regimen open label until doravirine becomes locally available or for an additional 96 weeks, whichever comes first. The primary hypothesis is that doravirine 100 mg once a day (q.d.) is non-inferior to darunavir/ritonavir (800 mg/100 mg) q.d., each in combination with TRUVADA™ or EPZICOM™/KIVEXA™, as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48. If non-inferiority is established, then the superiority of doravirine 100 mg q.d. compared to darunavir/ ritonavir (800 mg/100 mg) q.d. will be assessed.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Doravirine

Condition Name

Condition Name for Doravirine
Intervention Trials
HIV-1 Infection 13
HIV Infections 9
HIV-1-infection 7
Hiv 6
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Condition MeSH

Condition MeSH for Doravirine
Intervention Trials
HIV Infections 19
Acquired Immunodeficiency Syndrome 11
Immunologic Deficiency Syndromes 6
Infections 6
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Clinical Trial Locations for Doravirine

Trials by Country

Trials by Country for Doravirine
Location Trials
United States 105
France 42
Russian Federation 23
Spain 22
South Africa 20
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Trials by US State

Trials by US State for Doravirine
Location Trials
Texas 9
District of Columbia 9
Florida 8
California 8
Missouri 7
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Clinical Trial Progress for Doravirine

Clinical Trial Phase

Clinical Trial Phase for Doravirine
Clinical Trial Phase Trials
Phase 4 11
Phase 3 17
Phase 2 8
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Clinical Trial Status

Clinical Trial Status for Doravirine
Clinical Trial Phase Trials
Recruiting 15
Not yet recruiting 14
Completed 10
[disabled in preview] 9
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Clinical Trial Sponsors for Doravirine

Sponsor Name

Sponsor Name for Doravirine
Sponsor Trials
Merck Sharp & Dohme Corp. 25
Merck Sharp & Dohme LLC 7
Chelsea and Westminster NHS Foundation Trust 3
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Sponsor Type

Sponsor Type for Doravirine
Sponsor Trials
Other 41
Industry 35
NIH 2
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