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
Qualifiers
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
Treatments tested in this trial
- ISL
- ULO
- BIC/FTC/TAF
- Placebo for BIC/FTC/TAF
- Placebo to ISL/ULO
- ISL/ULO
Treatment groups
570 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov