A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)

Launched by MERCK SHARP & DOHME LLC · Nov 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment for people living with HIV-1. Specifically, it is looking at whether switching to a medication called Doravirine/Islatravir (DOR/ISL) is as safe and effective as continuing the current treatment that participants are already on. The trial will follow participants for 48 weeks to compare how well both treatments keep the virus in check and how well people tolerate the new medication.

To be eligible for the trial, participants need to be HIV-1 positive and have a very low level of the virus in their blood (less than 50 copies/mL) while on their current treatment for at least three months. Women who could become pregnant must use birth control or abstain from certain activities. Participants can expect regular check-ups and lab tests to monitor their health and the effectiveness of the treatment. It's important to note that people with certain health conditions, like active hepatitis or a recent serious infection, cannot participate. This study aims to find a potentially effective new treatment option for those managing HIV-1.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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