Status:
COMPLETED
Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HIV-1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 recei...
Detailed Description
Participants in Australia, Russia, and South Africa who are deriving benefit from MK-1439A are also eligible to continue receiving study drug during Study Extension 3, which will last for 2 years or u...
Eligibility Criteria
Inclusion
- Is HIV-1 positive and has HIV treatment indicated based on physician assessment.
- Has received no (0 days of) antiretroviral therapy (ART), including investigational antiretroviral agents.
- Is considered clinically stable with no signs or symptoms of active infection for at least 2 weeks prior to the start of treatment.
- Female is highly unlikely to become pregnant, or male is highly unlikely to impregnate a partner because they are not of reproductive potential, or agree to practice abstinence or use acceptable contraception for up to 14 days after the last dose of study drug.
- Eligibility for the Study Extension 1 at the Week 96 visit: 1) completed the Week 96 visit, 2) derived benefit from participation through Week 96 in the opinion of the investigator, 3) is a clinically-appropriate candidate for an additional 96 weeks of treatment with the Study Extension regimen.
- Eligibility for the Study Extension 2 at the Week 192 visit: 1) completed the Week 192 visit, 2) derived benefit from participation through Week 192 in the opinion of the investigator, 3) is a clinically-appropriate candidate for 96 weeks of treatment with the Study Extension regimen.
Exclusion
- Uses or has had a recent history of using recreational or illicit drugs.
- Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1.
- Has documented or known resistance to study drugs including doravirine, darunavir, ritonavir, emtricitabine, tenofovir, abacavir and/or lamivudine.
- Has participated in a study with an investigational compound/device within the prior month, or anticipates doing so during this study.
- Has used systemic immunosuppressive therapy or immune modulators within the prior 30 days, or anticipates doing so during this study.
- Has significant hypersensitivity or other contraindication to any of the components of the study drugs.
- Has a current (active) diagnosis of acute hepatitis due to any cause.
- Is pregnant, breastfeeding or expecting to conceive at any time during the study.
- Female who expects to donate eggs, or male who expects to donate sperm at any time during the study.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2023
Estimated Enrollment :
769 Patients enrolled
Trial Details
Trial ID
NCT02275780
Start Date
December 1 2014
End Date
March 6 2023
Last Update
October 1 2024
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