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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR DORAVIRINE

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Clinical Trials for Doravirine

Trial ID Title Status Sponsor Phase 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 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 Part 1 - Dose-Ranging. Part 1 will evaluate the (1) safety and tolerability and (2) efficacy (antiretroviral activity) of 4 doses of doravirine (MK-1439) compared with efavirenz, when each is given in combination with TRUVADA® for at least 24 weeks in approximately 200 participants. A single dose of doravirine will be selected for further study after all participants complete the Week 24 visit in Part 1. Participants receiving any dose of doravirine in Part 1 will be switched to the selected doravirine dose and continue in the study for up to 96 weeks. Part 2 - Selected Dose. Part 2 will be initiated after the doravirine dose has been selected as indicated above for Part 1. Approximately 120 additional participants will be randomized in 1:1 ratio to the selected dose of doravirine or efavirenz, each in combination with TRUVADA® for 96 weeks of blinded treatment. Part 2 will evaluate the safety of the selected dose compared with efavirenz, particularly with regard to central nervous system adverse events (CNS events). The hypothesis tested in this study is that MK-1439 at the final dose selected is superior to efavirenz, each given in combination with TRUVADA®, as measured by the proportion 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 This study will 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 will be compared with that of healthy control subjects matched with regard to mean age and weight. If a clinically meaningful increase in doravirine exposure is observed in participants with moderate hepatic insufficiency in Part 1, study Part 2 will 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 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 Extension Study. 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.
NCT02397096 Safety and Efficacy of a Switch to MK-1439A in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024) Recruiting Merck Sharp & Dohme Corp. Phase 3 The study will evaluate the safety and efficacy of a switch to MK-1439A (MK-1439 [doravirine] plus lamivudine and tenofovir disoproxil fumarate) in HIV-1-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to MK-1439A will be non-inferior to continuation of the regimen at Screening for 24 weeks, as assessed by the proportion of participants maintaining HIV-1 ribonucleic acid (RNA) <50 copies/mL. The Base Study will last up to 50 weeks. An optional Extension Study will evaluate long-term efficacy and safety of the switch to MK-1439A for an additional 2 years.
NCT02641067 A Study Evaluating the Pharmacokinetics of Doravirine in Participants With Severe Renal Impairment (MK-1439-051) Completed Merck Sharp & Dohme Corp. Phase 1 This study will evaluate the effect of severe renal impairment on the pharmacokinetics of doravirine.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Doravirine

Condition Name

Condition Name for Doravirine
Intervention Trials
HIV-1 Infection 5
HIV Infections 2
CNS Toxicity 1
Renal Impairment 1
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Condition MeSH

Condition MeSH for Doravirine
Intervention Trials
HIV Infections 3
Acquired Immunodeficiency Syndrome 2
Immunologic Deficiency Syndromes 1
Renal Insufficiency 1
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Clinical Trial Locations for Doravirine

Trials by Country

Trials by Country for Doravirine
Location Trials
United States 16
United Kingdom 2
Colombia 1
Spain 1
Australia 1
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Trials by US State

Trials by US State for Doravirine
Location Trials
Florida 1
District of Columbia 1
Colorado 1
California 1
Arkansas 1
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Clinical Trial Progress for Doravirine

Clinical Trial Phase

Clinical Trial Phase for Doravirine
Clinical Trial Phase Trials
Phase 3 2
Phase 2 3
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Doravirine
Clinical Trial Phase Trials
Completed 5
Not yet recruiting 2
Recruiting 2
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Clinical Trial Sponsors for Doravirine

Sponsor Name

Sponsor Name for Doravirine
Sponsor Trials
Merck Sharp & Dohme Corp. 9
National Institute of Allergy and Infectious Diseases (NIAID) 1
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Sponsor Type

Sponsor Type for Doravirine
Sponsor Trials
Industry 9
NIH 1
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Cantor Fitzgerald
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McKinsey
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Boehringer Ingelheim
Citi
UBS
Fish and Richardson

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