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Sponsor: Merck Sharp & Dohme LLC
Conditions: HIV-1 Infection
Interventions: ART, DOR/ISL
Countries: United States, Australia, Canada, Colombia, Japan, South Africa, Switzerland, United Kingdom
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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)
- Los Angeles, California, United States
- Palm Springs, California, United States
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- Ft. Pierce, Florida, United States
- Orlando, Florida, United States
- Sarasota, Florida, United States
- West Palm Beach, Florida, United States
- Decatur, Georgia, United States
- Savannah, Georgia, United States
- Hillsborough, New Jersey, United States
- Philadelphia, Pennsylvania, United States
- Austin, 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
- Hamilton, Ontario, Canada
- Toronto, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Montreal, Quebec, Canada
- Barranquilla, Atlántico, Colombia
- Barranquilla, Atlántico, Colombia
- Cali, Valle del Cauca Department, Colombia
- Nagoya, Aichi-ken, Japan
- Shinjuku-ku, Tokyo, Japan
- + 23 more on CT.gov