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NCT03272347 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of HIV-1-infection, sponsored by Merck Sharp & Dohme.

Completed
Registry status
Phase 2
Development phase
123
Enrollment target
20
Study locations

NCT03272347 is a Phase 2 study of HIV-1-infection that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 123 participants, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT03272347, a Phase 2 study of HIV-1-infection, has completed, sponsored by Merck Sharp & Dohme.

COMPLETED
Registry status
Phase 2
Development phase
123 participants
Enrollment target
20
Study locations

Study 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 Studied

Interventions

  • DRUG Doravirine
  • DRUG Lamivudine
  • DRUG Islatravir
  • DRUG Placebo to Islatravir
  • DRUG Placebo to Doravirine

Study Locations (20)

Other

  • Biomedica Research Group ( Site 0202) - Santiago
  • Hospital Dr. Hernan Henriquez Aravena ( Site 0203) - Temuco
  • Hopital Avicenne ( Site 2302) - Bobigny
  • Hopital Saint-Andre ( Site 2307) - Bordeaux
  • CHU Hotel Dieu ( Site 2308) - Nantes
  • CHU de Nice Hopital Archet 1 ( Site 2303) - Nice
  • Hopital Bichat - Claude Bernard ( Site 2309) - Paris
  • Hopital Pitie Salpetriere ( Site 2305) - Paris
  • Hopital Saint Louis ( Site 2306) - Paris

Texas

  • Saint Hope Foundation, Inc. ( Site 0116) - Bellaire
  • North Texas Infectious Diseases Consultants, PA ( Site 0103) - Dallas
  • Tarrant County Infectious Disease Associates ( Site 0112) - Fort Worth
  • The Crofoot Research Center, Inc. ( Site 0118) - Houston

Arizona

  • Pueblo Family Physicians ( Site 0119) - Phoenix

California

  • University California / Davis ( Site 0101) - Sacramento

District of Columbia

  • Whitman Walker Clinic ( Site 0108) - Washington D.C.

Florida

  • Orlando Immunology Center (OIC) ( Site 0105) - Orlando

Illinois

  • Northstar Medical Center ( Site 0102) - Chicago

Missouri

  • Kansas City CARE Clinic ( Site 0106) - Kansas City

Trial Details

FieldValue
Enrollment Target 123 participants
Start Date 2017-11-27
Est. Completion 2022-03-09
Phase Phase 2

Sponsor

Merck Sharp & Dohme

558 total trials

What the Registry Record Tells You About NCT03272347

The ClinicalTrials.gov registry entry for NCT03272347 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (65% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 5 interventions - of which Doravirine is the first listed.

NCT03272347 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Texas, Arizona.

Frequently Asked Questions

What is clinical trial NCT03272347 about?

NCT03272347 is a clinical study titled "Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)". 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 (HI...

What is the current status of trial NCT03272347?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2017-11-27. Estimated completion is 2022-03-09.

What conditions does trial NCT03272347 study?

This clinical trial studies the following conditions: HIV-1-infection.

What interventions are being tested in trial NCT03272347?

The interventions under investigation include: Doravirine (DRUG), Lamivudine (DRUG), Islatravir (DRUG), Placebo to Islatravir (DRUG), Placebo to Doravirine (DRUG).

Who is sponsoring clinical trial NCT03272347?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03272347 being conducted?

This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.