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Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)

NCT03272347 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2023-03-29

Study results available
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Summary

This study will evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics of 3 doses of islatravir (MK-8591) in combination with doravirine (DOR) and lamivudine (3TC) administered to antiretroviral treatment-naïve adult participants with human immunodeficiency virus type 1 (HIV-1) infection.

Conditions

  • HIV-1 Infection

Interventions

DRUG

Islatravir

Islatravir at 0.25 mg, 0.75 mg or 2.25 mg is orally administered QD in capsule form for up to 52 weeks. After Week 60 a selected open label dose may be administered.

DRUG

Placebo to Islatravir

Placebo to islatravir is orally administered QD in capsule form for up to 52 weeks

DRUG

Doravirine

Doravirine 100 mg is orally administered QD in tablet form for up to 144 weeks

DRUG

Placebo to Doravirine

Placebo to Doravirine is orally administered QD in tablet form for up to 52 weeks

DRUG

Lamivudine

Lamivudine 300 mg is orally administered QD in tablet form for up to 52 weeks

DRUG

Placebo to Lamivudine

Placebo to Lamivudine is orally administered QD in tablet form for up to 52 weeks

DRUG

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate

Fixed dose combination of 100 mg doravirine + 300 mg lamivudine + 300 mg tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 144 weeks.

DRUG

Placebo to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate

Placebo to doravirine/lamivudine/tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 52 weeks

DRUG

Doravirine/Islatravir

Fixed dose combination of islatravir 0.75 mg/doravirine 100 mg orally administered QD in tablet form for 48 weeks

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-27
Primary Completion
2021-03-08
Completion
2022-03-09
FDA Drug
Yes

Countries

  • United States
  • Chile
  • France
  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT03272347 on ClinicalTrials.gov