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)

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

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for people living with HIV-1 who are currently doing well on a medication called Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF). Researchers want to see if switching to a different combination of medications called Doravirine/Islatravir (DOR/ISL) can be just as effective or even better at keeping the virus under control after 48 weeks. The main goal is to find out if participants who switch to DOR/ISL have similar or lower levels of the virus compared to those who stay on BIC/FTC/TAF.

To be eligible for this trial, participants must be HIV-1 positive and have maintained low levels of the virus (less than 50 copies/mL) while on BIC/FTC/TAF for at least three months. They should also not have any ongoing serious health issues, such as active hepatitis or certain types of cancer, and women of childbearing potential must agree to use contraception. Throughout the study, participants can expect regular check-ups and monitoring to ensure their health and safety. This research is important as it could lead to new treatment options for HIV-1 that may offer benefits to patients.

Gender

ALL

Eligibility 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