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

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllMerck Sharp & Dohme LLC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 and ≤1,000,000 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. Exclusion Criteria: * 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. * Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1.
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What it tests

  • ISL
  • ULO
  • BIC/FTC/TAF
  • Placebo for BIC/FTC/TAF
  • Placebo to ISL/ULO
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Where

55 sites
Ruane Clinical Research Group, Inc. ( Site 1513)
Los Angeles, United States
Vivent Health ( Site 1519)
Denver, United States
Whitman-Walker Institute ( Site 1538)
Washington D.C., United States
Midway Immunology and Research Center ( Site 1503)
Ft. Pierce, United States
CAN Community Health- Miami Gardens ( Site 1549)
Miami Gardens, United States
Orlando Immunology Center ( Site 1501)
Orlando, United States
CAN Community Health ( Site 1510)
Sarasota, United States
Triple O Research Institute ( Site 1505)
West Palm Beach, United States

…and 47 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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