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)
Фаза 3 – широко изпитване преди одобрение
Заболявания:
HIV-1 Infection
Спонсор: Merck Sharp & Dohme LLC
Налично на:
БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria:
* Is Human Immunodeficiency Virus-1 (HIV-1) positive with plasma HIV-1 Ribonucleic Acid (RNA) \<50 copies/mL at screening
* Has been receiving continuous, stable oral 2-drug or 3-drug combination (± PK booster) antiretroviral therapy 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 Doravine (DOR)
Места на провеждане
8
Австралия (1)
Holdsworth House Medical Practice ( Site 4200)
Darlinghurst , New South Wales
Канада (1)
Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 3104)
Hamilton , Ontario
Colombia (1)
Ciensalud Ips S A S ( Site 3300)
Barranquilla , Atlántico
Япония (1)
National Hospital Organization Nagoya Medical Center ( Site 4403)
Nagoya , Aichi-ken
South Africa (1)
Josha Research ( Site 3903)
Bloemfontein , Free State
Швейцария (1)
University Hospital Basel-Infectiology ( Site 4002)
Basel , Canton of Basel-City
Великобритания (1)
Brighton and Sussex University Hospitals NHS Trust ( Site 4104)