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

NCT07266831

RecruitingPhase 2, Phase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Interventions: ISL, ULO, BIC/FTC/TAF, Placebo for BIC/FTC/TAF, Placebo to ISL/ULO

Countries: United States, Argentina, Canada, Chile, France, Guatemala, Mexico, South Africa

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 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.
Locations (55)
  • Los Angeles, California, United States
  • Denver, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Ft. Pierce, Florida, United States
  • Miami Gardens, Florida, United States
  • Orlando, Florida, United States
  • Sarasota, Florida, United States
  • West Palm Beach, Florida, United States
  • Decatur, Georgia, United States
  • Macon, Georgia, United States
  • Chicago, Illinois, United States
  • Detroit, Michigan, United States
  • Kansas City, Missouri, United States
  • Hillsborough, New Jersey, United States
  • Charlotte, North Carolina, United States
  • Greensboro, North Carolina, United States
  • Columbus, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Bellaire, Texas, United States
  • Dallas, Texas, United States
  • Dallas, Texas, United States
  • Fort Worth, Texas, United States
  • Longview, Texas, United States
  • Seattle, Washington, United States
  • Caba, Buenos Aires, Argentina
  • CABA, Buenos Aires, Argentina
  • Mar del Plata, Buenos Aires, Argentina
  • Buenos Aires, Buenos Aires F.D., Argentina
  • Rosario, Santa Fe Province, Argentina
  • San Miguel de Tucumán, Tucumán Province, Argentina
  • + 25 more on CT.gov