Study

Overview

Official Title: A Phase 3, Randomized, Active-Controlled, Double-Blind 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 Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)

The primary objectives of this study are to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued BIC/FTC/TAF at Week 48; and to evaluate the safety and tolerability of a switch to DOR/ISL compared with continued BIC/FTC/TAF, through Week 48. The primary hypotheses are that (1) DOR/ISL is non-inferior to continued BIC/FTC/TAF, 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; and (2) DOR/ISL is superior to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48.

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

501

Study Start Date:

February 2023

Estimated Study Completion Date:

October 2025

Estimated Primary Completion Date:

November 2024

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

CRITERIA

The key inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL
Has been receiving BIC/FTC/TAF therapy 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 participant of childbearing potential, not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration

Exclusion Criteria:

Has HIV-2 infection
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 with laboratory values consistent with cirrhosis
Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi’s sarcoma
Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A ) inducers
Has a documented or known virologic resistance to DOR
Has taken long-acting HIV therapy at any time (e.g., cabotegravir, lenacapavir)
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 except those currently enrolled in the comparator arm of an ongoing DOR/ISL study

Study Detail

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants with Human Immunodeficiency Virus Type 1 (HIV-1) who are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)

Overview

Eligibility

CRITERIA

Locations

Results

Plain Language Summaries