A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)

Condition(s) studied

Investigational drug(s) / intervention(s)

ISL: ISL 2 x 1 mg oral capsules administered qw for 96 weeks

ULO: ULO 2 x 100 mg oral tablets administered qw for 96 weeks

BIC/FTC/TAF: BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks

Placebo for BIC/FTC/TAF: BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks

Placebo to ISL/ULO: ISL/ULO-matching placebo oral tablets administered qw for 96 weeks

ISL/ULO: ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks

Study summary

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

Primary outcome measure(s)

• Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24 — 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.
• Phase 2: Percentage of Participants Who Experience an Adverse Event (AE) at Week 24 — 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.
• Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24 — 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.
• Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 — 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.
• Phase 3: Percentage of Participants Who Experience an AE at Week 48 — 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.
• Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 48 — 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.

Trial sites (55)

+ 15 more sites — see the full list on the official registry below.

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