NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Merck Sharp & Dohme LLC
Conditions: HIV-1 Infection
Interventions: DOR/ISL, BIC/FTC/TAF, Placebo to BIC/FTC/TAF, Placebo to DOR/ISL
Countries: United States, Australia, Chile, Israel, Japan, United Kingdom
The primary objectives of this study are to evaluate the antiretroviral activity of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued Bictegravir/Emtricitabine/Tenofovir Alafenamide (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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Phoenix, Arizona, United States
- Beverly Hills, California, United States
- Los Angeles, California, United States
- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- Fort Lauderdale, Florida, United States
- Ft. Pierce, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- West Palm Beach, Florida, United States
- Decatur, Georgia, United States
- Macon, Georgia, United States
- Boston, Massachusetts, United States
- Berkley, Michigan, United States
- Kansas City, Missouri, United States
- Las Vegas, Nevada, United States
- Greensboro, North Carolina, United States
- Austin, Texas, United States
- Bellaire, Texas, United States
- Dallas, Texas, United States
- Dallas, Texas, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- Longview, Texas, United States
- Darlinghurst, New South Wales, Australia
- Sydney, New South Wales, Australia
- Brisbane, Queensland, Australia
- Brisbane, Queensland, Australia
- Melbourne, Victoria, Australia
- Temuco, Araucania, Chile
- + 19 more on CT.gov