This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL \[MK-8591A\]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
537
Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.
Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth.
Placebo tablet matched to DOR/ISL tablet taken by mouth.
Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay with a lower limit of detection of \<50 copies/mL.
Time frame: Week 48
Percentage of participants experiencing ≥1 adverse event (AE) through Week 48
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to 48 weeks
Percentage of participants discontinuing from study treatment due to an AE through Week 48
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to 48 weeks
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of \<50 copies/mL.
Time frame: Week 96
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 144
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of \<50 copies/mL.
Time frame: Week 144
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of \<50 copies/mL.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth.
Pueblo Family Physicians ( Site 5674)
Phoenix, Arizona, United States
Pacific Oaks Medical Group ( Site 5681)
Beverly Hills, California, United States
Ruane Clinical Research Group, Inc ( Site 5658)
Los Angeles, California, United States
Vivent Health ( Site 5694)
Denver, Colorado, United States
Washington Health Institute ( Site 5689)
Washington D.C., District of Columbia, United States
Midway Immunology and Research Center ( Site 5657)
Ft. Pierce, Florida, United States
AHF The Kinder Medical Group ( Site 5672)
Miami, Florida, United States
AHF South Beach ( Site 5663)
Miami Beach, Florida, United States
Orlando Immunology Center ( Site 5654)
Orlando, Florida, United States
CAN Community Health - Sarasota ( Site 5668)
Sarasota, Florida, United States
...and 121 more locations
Time frame: Week 48
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of \<50 copies/mL.
Time frame: Week 96
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 144
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of \<50 copies/mL.
Time frame: Week 144
Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48
CD4+ T-cells are quantified with a T and B lymphocyte and natural killer cell (TBNK) panel.
Time frame: Baseline (Day 1) and Week 48
Change from baseline in CD4+ T-cells at Week 96
CD4+ T-cells are quantified with a TBNK panel.
Time frame: Baseline (Day 1) and Week 96
Change from baseline in CD4+ T-cells at Week 144
CD4+ T-cells are quantified with a TBNK panel.
Time frame: Baseline (Day 1) and Week 144
Incidence of viral drug resistance
Plasma samples will be collected for genotypic and phenotypic HIV-1 viral drug resistance testing and used to assess resistance-associated substitutions and viral susceptibility as applicable during the study.
Time frame: Up to 96 weeks
Change from baseline in body weight at Week 48
Body weight will be collected throughout the study.
Time frame: Baseline (Day 1) and Week 48
Change from baseline in body weight at Week 96
Body weight will be collected throughout the study.
Time frame: Baseline (Day 1) and Week 96
Change from baseline in body weight at Week 144
Body weight will be collected throughout the study.
Time frame: Baseline (Day 1) and Week 144
Percentage of participants experiencing ≥1 AE through Week 144
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to 144 weeks
Percentage of participants discontinuing from study treatment due to an AE through Week 144
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to 144 weeks