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
Sites (89)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| LKH Graz West ( Site 3401) Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Social Medical Center - Otto Wagner Hospital ( Site 3404) Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital ( Site 3400) Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Medical University Vienna ( Site 3402) Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Holdsworth House Medical Practice - Brisbane ( Site 3810) Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| St Vincent's Hospital ( Site 3807) Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Taylor Square Private Clinic ( Site 3804) Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 3812) Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| Prahran Market Clinic (PMC) ( Site 3806) Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| The Alfred Hospital ( Site 3802) Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Holdsworth House Medical Practice ( Site 3800) Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Hamilton Health Sciences ( Site 2803) Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Clinique de Medecine Urbaine du Quartier Latin ( Site 2804) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Clinique Medicale L Actuel ( Site 2814) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Vancouver ID Research and Care Centre Society ( Site 2800) Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 3003) Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| EPIMED GmbH ( Site 3008) Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Universitaetsklinikum Bonn ( Site 3000) Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| Universitaetsklinikum Essen ( Site 3007) Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Infektiologikum ( Site 3001) Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Unknown status |
| ICH Study Center GmbH & Co.KG ( Site 3009) Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 3010) Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Medizinische Hochschule Hannover ( Site 3012) Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| MVZ Karlsplatz Dr.med.Hans Jaeger ( Site 3002) Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Klinikum der LMU München ( Site 3004) Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Klinikum rechts der Isar der Technischen Universitat ( Site 3005) Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Hospital Universitari Germans Trias i Pujol ( Site 3601) Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital Clinic i Provincial ( Site 3600) Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari Vall d Hebron ( Site 3602) Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitari de Bellvitge ( Site 3612) Coordinator of this site? Confirm its status | LHospitalet de Llobregat | Spain | Unknown status |
| Hospital 12 de Octubre de Madrid ( Site 3605) Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Infanta Leonor ( Site 3606) Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario La Paz ( Site 3604) Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital General Universitario Gregorio Maranon ( Site 3603) Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Ramon y Cajal ( Site 3611) Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Virgen de la Victoria ( Site 3609) Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Helsinki University Hospital ( Site 3200) Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| Hopital Edouard Herriot ( Site 3126) Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hopital Europeen Marseille ( Site 3117) Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| CHU de Montpellier - Hopital Saint-Eloi ( Site 3121) Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHU Hotel Dieu Nantes ( Site 3120) Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| CHU de Nice Hopital Archet 1 ( Site 3103) Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Centre Hospitalier Regional du Orleans ( Site 3108) Coordinator of this site? Confirm its status | Orléans | France | Unknown status |
| Hopital Pitie Salpetriere ( Site 3111) Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Saint-Antoine ( Site 3113) Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Tenon ( Site 3118) Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Foch ( Site 3129) Coordinator of this site? Confirm its status | Suresnes | France | Unknown status |
| Centre Hospitalier de Tourcoing ( Site 3100) Coordinator of this site? Confirm its status | Tourcoing | France | Unknown status |
| CHU de Nancy Hopital Brabois Adultes ( Site 3128) Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Azienda Ospedaliera San Paolo ( Site 3503) Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Universita' Vita Salute. Ospedale San Raffaele ( Site 3502) Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 3501) Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| ASST Fatebenefratelli-Ospedale Sacco ( Site 3500) Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| A.O.R.N. dei Colli - Ospedale Cotugno ( Site 3507) Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| National Hospital Organization Nagoya Medical Center ( Site 7203) Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| National Hospital Organization Osaka National Hospital ( Site 7202) Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Center Hospital of the National Center for Global Health and Medicine ( Site 7201) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| CAIMED Center - Ponce School of Medicine ( Site 2903) Coordinator of this site? Confirm its status | Ponce | Puerto Rico | Unknown status |
| Puerto Rico CONCRA ( Site 2904) Coordinator of this site? Confirm its status | Rio Piedras | Puerto Rico | Unknown status |
| Hope Clinical Research, Inc. ( Site 2902) Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Clinical Research Puerto Rico Inc ( Site 2900) Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Augusta University ( Site 2752) Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Pacific Oaks Medical Group ( Site 2765) Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| North Texas ID Consultants, PA ( Site 2707) Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Infectious Disease Specialists Of Atlanta PC ( Site 2719) Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| TheraFirst Medical Center ( Site 2742) Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Midway Immunology and Research ( Site 2759) Coordinator of this site? Confirm its status | Ft. Pierce | United States | Unknown status |
| ID Care ( Site 2751) Coordinator of this site? Confirm its status | Hillsborough | United States | Unknown status |
| The Crofoot Research Center, Inc. ( Site 2715) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Kansas City CARE Clinic ( Site 2718) Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| DCOL Center for Clinical Research ( Site 2769) Coordinator of this site? Confirm its status | Longview | United States | Unknown status |
| Men's Health Foundation ( Site 2749) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Kaiser Permanente Los Angeles Medical Center ( Site 2775) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Mercer University ( Site 2738) Coordinator of this site? Confirm its status | Macon | United States | Unknown status |
| The Kinder Medical Group ( Site 2739) Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| AHF South Beach ( Site 2780) Coordinator of this site? Confirm its status | Miami Beach | United States | Unknown status |
| Hennepin County Medical Center ( Site 2733) Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai ( Site 2700) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Orlando Immunology Center ( Site 2734) Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Eisenhower Medical Center ( Site 2744) Coordinator of this site? Confirm its status | Palm Springs | United States | Unknown status |
| Pueblo Family Physicians ( Site 2717) Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| University of California, Davis, Division of ID Research ( Site 2702) Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Zuckerberg San Francisco General Hospital UCSF ( Site 2743) Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Chatham County Health Department ( Site 2731) Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Dr. Peter Shalit, MD ( Site 2770) Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Multicare Health System ( Site 2713) Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Montefiore Einstein Center ( Site 2730) Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Whitman-Walker Clinic ( Site 2728) Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Triple O Research Institute, P.A. ( Site 2755) Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.