A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL.
Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 copies/mL.
Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells/mm^3.
Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection.
Disqualifiers
Has human immunodeficiency virus type 2 (HIV-2) infection.
Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection.
Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.
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 or in situ anal cancer, or cutaneous Kaposi's sarcoma.
Trial design
Design model
Parallel
Treatments tested in this trial
ISL
DrugISL 2 x 1 mg oral capsules administered qw for 96 weeks
ULO
DrugULO 2 x 100 mg oral tablets administered qw for 96 weeks
BIC/FTC/TAF
DrugBIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks
Placebo for BIC/FTC/TAF
DrugBIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks
Placebo to ISL/ULO
DrugISL/ULO-matching placebo oral tablets administered qw for 96 weeks
ISL/ULO
DrugISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks
Treatment groups
570 Participants
are divided into 4 treatment groupsGroup A: Phase 2: ISL + ULOExperimental treatment 2 interventions
Group B: Phase 2: BIC/FTC/TAFActive comparator 1 intervention
Group C: Phase 3: ISL/ULO and Placebo to BIC/FTC/TAFExperimental treatment 2 interventions
Group D: Phase 3: BIC/FTC/TAF and Placebo to ISL/ULOActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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 242
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 243
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 244
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 48Secondary outcomes
1
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 482
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 963
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 244
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 48Sponsors and contacts
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Source ClinicalTrials.gov