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NCT04223791CompletedPhase 3

Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

This study will evaluate the safety and efficacy of a switch to Doravirine/Islatravir (DOR/ISL) (MK-8591A) (a fixed dose combination of doravirine 100 mg and islatravir 0.75 mg) in participants living with human immunodeficiency virus-1 (HIV-1) virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to DOR/ISL (MK-8591A) will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
643 (actual)
First submitted
8 Jan 2020
Start date
18 Feb 2020
Primary completion date
26 Aug 2021
Lead sponsor
Merck Sharp & Dohme LLC
Diseases
HIV
NCT number
NCT04223791
EudraCT number
2019-000587-23

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 643
  • From 18 Feb 2020 to the primary completion date, 26 Aug 2021
  • 89 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies.
  • Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period.

Other illness

  • Has HIV-2 infection.
  • Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection.

Age

  • Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma.

Other

  • Has a documented or known virologic resistance to doravirine (DOR).
  • expects to conceive or donate eggs at any time during the study.

Who the study is looking for

  • Is HIV-1 positive with plasma Human Immunodeficiency Virus 1 (HIV-1) RNA \<50 copies/mL at screening.
  • Has been receiving bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) therapy with documented viral suppression (HIV-1 RNA \<50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen.
  • Females are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (89)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
LKH Graz West ( Site 3401)
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GrazAustriaUnknown status
Social Medical Center - Otto Wagner Hospital ( Site 3404)
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ViennaAustriaUnknown status
Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital ( Site 3400)
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ViennaAustriaUnknown status
Medical University Vienna ( Site 3402)
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ViennaAustriaUnknown status
Holdsworth House Medical Practice - Brisbane ( Site 3810)
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BrisbaneAustraliaUnknown status
St Vincent's Hospital ( Site 3807)
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DarlinghurstAustraliaUnknown status
Taylor Square Private Clinic ( Site 3804)
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DarlinghurstAustraliaUnknown status
Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 3812)
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HerstonAustraliaUnknown status
Prahran Market Clinic (PMC) ( Site 3806)
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MelbourneAustraliaUnknown status
The Alfred Hospital ( Site 3802)
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MelbourneAustraliaUnknown status
Holdsworth House Medical Practice ( Site 3800)
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SydneyAustraliaUnknown status
Hamilton Health Sciences ( Site 2803)
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HamiltonCanadaUnknown status
Clinique de Medecine Urbaine du Quartier Latin ( Site 2804)
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MontrealCanadaUnknown status
Clinique Medicale L Actuel ( Site 2814)
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MontrealCanadaUnknown status
Vancouver ID Research and Care Centre Society ( Site 2800)
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VancouverCanadaUnknown status
ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 3003)
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BerlinGermanyUnknown status
EPIMED GmbH ( Site 3008)
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BerlinGermanyUnknown status
Universitaetsklinikum Bonn ( Site 3000)
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BonnGermanyUnknown status
Universitaetsklinikum Essen ( Site 3007)
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EssenGermanyUnknown status
Infektiologikum ( Site 3001)
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Frankfurt am MainGermanyUnknown status
ICH Study Center GmbH & Co.KG ( Site 3009)
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HamburgGermanyUnknown status
Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 3010)
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HamburgGermanyUnknown status
Medizinische Hochschule Hannover ( Site 3012)
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HanoverGermanyUnknown status
MVZ Karlsplatz Dr.med.Hans Jaeger ( Site 3002)
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MunichGermanyUnknown status
Klinikum der LMU München ( Site 3004)
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MunichGermanyUnknown status
Klinikum rechts der Isar der Technischen Universitat ( Site 3005)
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MunichGermanyUnknown status
Hospital Universitari Germans Trias i Pujol ( Site 3601)
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BadalonaSpainUnknown status
Hospital Clinic i Provincial ( Site 3600)
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BarcelonaSpainUnknown status
Hospital Universitari Vall d Hebron ( Site 3602)
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BarcelonaSpainUnknown status
Hospital Universitari de Bellvitge ( Site 3612)
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LHospitalet de LlobregatSpainUnknown status
Hospital 12 de Octubre de Madrid ( Site 3605)
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MadridSpainUnknown status
Hospital Universitario Infanta Leonor ( Site 3606)
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MadridSpainUnknown status
Hospital Universitario La Paz ( Site 3604)
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MadridSpainUnknown status
Hospital General Universitario Gregorio Maranon ( Site 3603)
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MadridSpainUnknown status
Hospital Universitario Ramon y Cajal ( Site 3611)
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MadridSpainUnknown status
Hospital Universitario Virgen de la Victoria ( Site 3609)
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MálagaSpainUnknown status
Helsinki University Hospital ( Site 3200)
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HelsinkiFinlandUnknown status
Hopital Edouard Herriot ( Site 3126)
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LyonFranceUnknown status
Hopital Europeen Marseille ( Site 3117)
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MarseilleFranceUnknown status
CHU de Montpellier - Hopital Saint-Eloi ( Site 3121)
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MontpellierFranceUnknown status
CHU Hotel Dieu Nantes ( Site 3120)
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NantesFranceUnknown status
CHU de Nice Hopital Archet 1 ( Site 3103)
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NiceFranceUnknown status
Centre Hospitalier Regional du Orleans ( Site 3108)
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OrléansFranceUnknown status
Hopital Pitie Salpetriere ( Site 3111)
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ParisFranceUnknown status
Hopital Saint-Antoine ( Site 3113)
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ParisFranceUnknown status
Hopital Tenon ( Site 3118)
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ParisFranceUnknown status
Hopital Foch ( Site 3129)
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SuresnesFranceUnknown status
Centre Hospitalier de Tourcoing ( Site 3100)
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TourcoingFranceUnknown status
CHU de Nancy Hopital Brabois Adultes ( Site 3128)
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Vandœuvre-lès-NancyFranceUnknown status
Azienda Ospedaliera San Paolo ( Site 3503)
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MilanItalyUnknown status
Universita' Vita Salute. Ospedale San Raffaele ( Site 3502)
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MilanItalyUnknown status
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 3501)
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MilanItalyUnknown status
ASST Fatebenefratelli-Ospedale Sacco ( Site 3500)
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MilanItalyUnknown status
A.O.R.N. dei Colli - Ospedale Cotugno ( Site 3507)
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NaplesItalyUnknown status
National Hospital Organization Nagoya Medical Center ( Site 7203)
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NagoyaJapanUnknown status
National Hospital Organization Osaka National Hospital ( Site 7202)
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OsakaJapanUnknown status
Center Hospital of the National Center for Global Health and Medicine ( Site 7201)
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TokyoJapanUnknown status
CAIMED Center - Ponce School of Medicine ( Site 2903)
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PoncePuerto RicoUnknown status
Puerto Rico CONCRA ( Site 2904)
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Rio PiedrasPuerto RicoUnknown status
Hope Clinical Research, Inc. ( Site 2902)
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San JuanPuerto RicoUnknown status
Clinical Research Puerto Rico Inc ( Site 2900)
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San JuanPuerto RicoUnknown status
Augusta University ( Site 2752)
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AugustaUnited StatesUnknown status
Pacific Oaks Medical Group ( Site 2765)
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Beverly HillsUnited StatesUnknown status
North Texas ID Consultants, PA ( Site 2707)
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DallasUnited StatesUnknown status
Infectious Disease Specialists Of Atlanta PC ( Site 2719)
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DecaturUnited StatesUnknown status
TheraFirst Medical Center ( Site 2742)
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Fort LauderdaleUnited StatesUnknown status
Midway Immunology and Research ( Site 2759)
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Ft. PierceUnited StatesUnknown status
ID Care ( Site 2751)
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HillsboroughUnited StatesUnknown status
The Crofoot Research Center, Inc. ( Site 2715)
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HoustonUnited StatesUnknown status
Kansas City CARE Clinic ( Site 2718)
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Kansas CityUnited StatesUnknown status
DCOL Center for Clinical Research ( Site 2769)
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LongviewUnited StatesUnknown status
Men's Health Foundation ( Site 2749)
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Los AngelesUnited StatesUnknown status
Kaiser Permanente Los Angeles Medical Center ( Site 2775)
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Los AngelesUnited StatesUnknown status
Mercer University ( Site 2738)
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MaconUnited StatesUnknown status
The Kinder Medical Group ( Site 2739)
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MiamiUnited StatesUnknown status
AHF South Beach ( Site 2780)
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Miami BeachUnited StatesUnknown status
Hennepin County Medical Center ( Site 2733)
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MinneapolisUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai ( Site 2700)
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New YorkUnited StatesUnknown status
Orlando Immunology Center ( Site 2734)
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OrlandoUnited StatesUnknown status
Eisenhower Medical Center ( Site 2744)
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Palm SpringsUnited StatesUnknown status
Pueblo Family Physicians ( Site 2717)
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PhoenixUnited StatesUnknown status
University of California, Davis, Division of ID Research ( Site 2702)
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SacramentoUnited StatesUnknown status
Zuckerberg San Francisco General Hospital UCSF ( Site 2743)
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San FranciscoUnited StatesUnknown status
Chatham County Health Department ( Site 2731)
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SavannahUnited StatesUnknown status
Dr. Peter Shalit, MD ( Site 2770)
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SeattleUnited StatesUnknown status
Multicare Health System ( Site 2713)
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SpokaneUnited StatesUnknown status
Montefiore Einstein Center ( Site 2730)
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The BronxUnited StatesUnknown status
Whitman-Walker Clinic ( Site 2728)
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Washington D.C.United StatesUnknown status
Triple O Research Institute, P.A. ( Site 2755)
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West Palm BeachUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.