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A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)
A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

NCT05766501

Active Not RecruitingPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: HIV Infection

Interventions: DOR/ISL

Countries: United States, Argentina, Australia, Canada, Chile, Colombia, Israel, Japan

The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp \& Dohme (MSD)-sponsored clinical studies (MK-8591A-018, -020, and -033 \[except for heavily treatment-experienced (HTE) participants\]).

Exclusion Criteria:

* Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033.
* Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL.
* Is a HTE participant receiving treatment in MK-8591A-019 or -033.
Locations (95)
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • Beverly Hills, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Sacramento, California, United States
  • Washington D.C., District of Columbia, United States
  • Fort Lauderdale, Florida, United States
  • Ft. Pierce, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Sarasota, Florida, United States
  • West Palm Beach, Florida, United States
  • Augusta, Georgia, United States
  • Decatur, Georgia, United States
  • Macon, Georgia, United States
  • Savannah, Georgia, United States
  • Kansas City, Missouri, United States
  • Hillsborough, New Jersey, United States
  • New York, New York, United States
  • Philadelphia, Pennsylvania, United States
  • Bellaire, Texas, United States
  • Dallas, Texas, United States
  • Fort Worth, Texas, United States
  • Houston, Texas, United States
  • Longview, Texas, United States
  • Seattle, Washington, United States
  • + 65 more on CT.gov