This study is in progress, not accepting new patients

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 on HIV/AIDS Immunodeficiency

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

Summary

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.

Official Title

A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study

Keywords

HIV Infection, Infections, Communicable Diseases, Islatravir, DOR/ISL

Eligibility

You can join if…

Open to people ages 18 years and up

  • Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp & Dohme (MSD)-sponsored clinical studies (MK-8591A-017, -018, -020, and -033 [except for heavily treatment-experienced (HTE) participants]).

You CAN'T join if...

  • Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-017 /-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

  • University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137)
    Sacramento California 95817 United States
  • Pacific Oaks Medical Group ( Site 3123)
    Beverly Hills California 90211 United States
  • Mills Clinical Research ( Site 3114)
    Los Angeles California 90069 United States
  • Ruane Clinical Research Group, Inc ( Site 3126)
    Los Angeles California 90036 United States
  • Kaiser Permanente ( Site 3124)
    Los Angeles California 90027 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Merck Clinical Trials Information Plain Language Summary
ID
NCT05766501
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 650 study participants
Last Updated