Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
570
ISL 2 x 1 mg oral capsules administered qw for 96 weeks
ULO 2 x 100 mg oral tablets administered qw for 96 weeks
BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks
BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks
ISL/ULO-matching placebo oral tablets administered qw for 96 weeks
ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks
Ruane Clinical Research Group, Inc. ( Site 1513)
Los Angeles, California, United States
RECRUITINGVivent Health ( Site 1519)
Denver, Colorado, United States
RECRUITINGWhitman-Walker Institute ( Site 1538)
Washington D.C., District of Columbia, United States
RECRUITINGMidway Immunology and Research Center ( Site 1503)
Ft. Pierce, Florida, United States
Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24
Plasma HIV-1 ribonucleic acid (RNA) quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 24.
Time frame: Week 24
Phase 2: Percentage of Participants Who Experience an Adverse Event (AE) at Week 24
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Week 24
Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Week 24
Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 48.
Time frame: Week 48
Phase 3: Percentage of Participants Who Experience an AE at Week 48
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Week 48
Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 48
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Week 48
Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 48.
Time frame: Week 48
Phase 2: 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. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 96.
Time frame: Week 96
Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 24
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<200 copies/mL will be reported at week 24.
Time frame: Week 24
Phase 2: 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. Percentage of participants with HIV-1 RNA \<200 copies/mL will be reported at week 48.
Time frame: Week 48
Phase 2: 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. Percentage of participants with HIV-1 RNA \<200 copies/mL will be reported at week 96.
Time frame: Week 96
Phase 2: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 24
Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 24 weeks.
Time frame: Baseline (Day 1) and Week 24
Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 48
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CAN Community Health- Miami Gardens ( Site 1549)
Miami Gardens, Florida, United States
RECRUITINGOrlando Immunology Center ( Site 1501)
Orlando, Florida, United States
RECRUITINGCAN Community Health ( Site 1510)
Sarasota, Florida, United States
RECRUITINGTriple O Research Institute ( Site 1505)
West Palm Beach, Florida, United States
RECRUITINGMetro Infectious Diseases Consultants L.L.C. ( Site 1509)
Decatur, Georgia, United States
RECRUITINGMercer university, Department of internal medicine-Clinical Research ( Site 1512)
Macon, Georgia, United States
RECRUITING...and 45 more locations
Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 48 weeks.
Time frame: Baseline (Day 1) and Week 48
Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 96
Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 96 weeks.
Time frame: Baseline (Day 1) and Week 96
Phase 2: Percentage of Participants Who Experience an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Up to approximately 102 weeks
Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Up to approximately 96 weeks
Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 24
Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 24 will be presented.
Time frame: Week 24
Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48
Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 48 will be presented.
Time frame: Week 48
Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96
Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 96 will be presented.
Time frame: Week 96
Phase 3: 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. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 96.
Time frame: Week 96
Phase 3: 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. Percentage of participants with HIV-1 RNA \<200 copies/mL will be reported at week 48.
Time frame: Week 48
Phase 3: 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. Percentage of participants with HIV-1 RNA \<200 copies/mL will be reported at week 96.
Time frame: Week 96
Phase 3: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 48
Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 48 weeks.
Time frame: Baseline (Day 1) and Week 48
Phase 3: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 96
Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 96 weeks.
Time frame: Baseline (Day 1) and Week 96
Phase 3: Percentage of Participants Who Experience an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Up to approximately 102 weeks
Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Up to approximately 96 weeks
Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48
Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 48 will be presented.
Time frame: Week 48
Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96
Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 96 will be presented.
Time frame: Week 96
Phase 3: Mean 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
Phase 3: Mean 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