A Study of Islatravir (MK-8591) in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003)
Completed
Merck Sharp & Dohme Corp.
Phase 1
This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral
therapy (ART) activity of islatravir (MK-8591) monotherapy in ART-naive, human
immunodeficiency virus-1 (HIV-1) infected participants. The primary hypothesis is that at a
safe and tolerable dose of islatravir, the true mean difference in the plasma HIV-1
ribonucleic acid (RNA) reduction from baseline between islatravir and placebo is at least 0.5
log (base10) copies/mL.
Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)
Active, not recruiting
Merck Sharp & Dohme Corp.
Phase 2
This study will evaluate the safety, tolerability, antiretroviral activity, and
pharmacokinetics of 3 doses of islatravir (MK-8591) in combination with doravirine (DOR) and
lamivudine (3TC) administered to antiretroviral treatment-naïve adult participants with human
immunodeficiency virus type 1 (HIV-1) infection.
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
Active, not recruiting
Merck Sharp & Dohme Corp.
Phase 2
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of 6 once-monthly
doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of
HIV-1 infection
Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017))
Active, not recruiting
Merck Sharp & Dohme Corp.
Phase 3
This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose
combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected
participants virologically suppressed on a protocol-specified antiretroviral regimen. The
primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment
with baseline antiretroviral therapy (ART) as assessed by the proportion of participants with
HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.
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