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Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)

NCT04233216 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-12-27

Study results available
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Summary

This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that the percentage of participants receiving DOR/ISL to achieve ≥0.5 log10 decrease in HIV-1 ribonucleic acid (RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination with failing antiretroviral therapy (ART).

Conditions

  • HIV-1 Infection

Interventions

DRUG

ISL

ISL 0.75 mg capsule taken by mouth.

DRUG

DOR

DOR 100 mg tablet taken by mouth.

DRUG

DOR/ISL

100 mg DOR/0.75 mg ISL FDC taken by mouth.

DRUG

Placebo to ISL

Placebo capsule matched to ISL taken by mouth.

DRUG

Placebo to DOR

Placebo tablet matched to DOR taken by mouth.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-18
Primary Completion
2022-11-21
Completion
2023-11-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Chile
  • Colombia
  • France
  • Germany
  • Italy
  • Japan
  • Peru
  • Portugal
  • Puerto Rico
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04233216 on ClinicalTrials.gov