for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
completion around



The primary objectives of this study are to evaluate the safety and tolerability of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued baseline antiretroviral therapy (ART), through Week 48; and to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued baseline ART at Week 48. The primary hypothesis is that DOR/ISL is non-inferior to continued baseline ART, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority.

Official Title

A Phase 3, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Antiretroviral Therapy


HIV-1 Infection, Islatravir, ART, DOR/ISL, ART + DOR/ISL


You can join if…

Open to people ages 18 years and up

  • Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL at screening
  • Has been receiving continuous, stable oral 2-drug or 3-drug combination (± PK booster) ART with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen
  • Female is not a participant of childbearing potential (POCBP); or if a POCBP uses an acceptable contraceptive method or abstains from penile-vaginal intercourse as their preferred and usual lifestyle; has a negative highly sensitive pregnancy test; and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator

You CAN'T join if...

  • Has HIV-2 infection
  • Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
  • Has a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening
  • Has active hepatitis B virus (HBV) infection
  • Has chronic hepatitis C virus (HCV) infection consistent with cirrhosis
  • Has a ≤5 years prior history of malignancy
  • Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A ) inducers
  • Has taken long-acting HIV therapy at any time
  • Is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to Day 1 through the study treatment period
  • Has a documented or known virologic resistance to DOR


  • Zuckerberg San Francisco General Hospital and Trauma Center-UCSF ID Clinical Trials Center ( Site 30
    San Francisco California 94110 United States
  • Kaiser Permanente-Infectious Disease ( Site 3014)
    Los Angeles California 90027 United States


in progress, not accepting new patients
Start Date
Completion Date
Merck Sharp & Dohme LLC
Merck Clinical Trials Information Plain Language Summary
Phase 3 research study
Study Type
Expecting 501 study participants
Last Updated