Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Not authorised
Participants planned
1,312
Countries
6
Sites
57
HIV-1 infection
To evaluate the safety and tolerability of DOR/ISL (100 mg/0.25 mg) as assessed by accumulated safety data through Week 96
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2023-05-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2022-502126-40-00
- WHO UTN
- U1111-1283-3863
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Efficacy, Therapy
To evaluate the safety and tolerability of DOR/ISL (100 mg/0.25 mg) as assessed by accumulated safety data through Week 96
Secondary objectives 2
- To evaluate the antiretroviral activity of DOR/ISL (100 mg/0.25 mg) as assessed by the percentage of participants with the following at Week 96: • HIV-1 RNA ≥50 copies/mL • HIV-1 RNA <50 copies/mL • HIV-1 RNA ≥200 copies/mL
- To evaluate the development of viral resistance to DOR/ISL (100 mg/0.25 mg)
Conditions and MedDRA coding
HIV-1 infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10068341 | HIV-1 infection | 10021881 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp & Dohme (MSD)-sponsored clinical studies (MK-8591A-017, -018, -020, and -033 [except for heavily treatment-experienced (HTE) participants]).
Exclusion criteria 3
- Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-017 /-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033.
- Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL.
- Is a HTE participant receiving treatment in MK-8591A-019 or -033.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Percentage of participants with one or more adverse events
- Percentage of participants who discontinue study intervention due to adverse events
Secondary endpoints 4
- Percentage of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 96
- Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96
- Percentage of participants with HIV-1 RNA ≥200 copies/mL at Week 96
- Percentage of participants with evidence of viral drug resistance-associated substitutions
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9952827 · Product
- Active substance
- Doravirine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 100.25 mg milligram(s)
- Max total dose
- 182956.25 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Wayne Greaves
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Wayne Greaves
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International Corporation ORG-100007310
|
Auburndale, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100044131
|
Indianapolis, United States | Laboratory analysis |
| Perceptive Eclinical Limited ORG-100041144
|
Nottingham, United Kingdom | Other |
| Pharma Medica Research Inc. ORG-100011951
|
Mississauga, Canada | Laboratory analysis |
Locations
6 EU/EEA countries · 57 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Not authorised | 5 | 1 |
| France | Not authorised | 83 | 19 |
| Germany | Not authorised | 110 | 11 |
| Italy | Not authorised | 92 | 10 |
| Poland | Not authorised | 28 | 4 |
| Spain | Not authorised | 38 | 12 |
| Rest of world
Australia, South Africa, Russian Federation, Argentina, Japan, Switzerland, United States, New Zealand, Israel, Canada, Chile, Puerto Rico, United Kingdom, Colombia, Taiwan
|
— | 956 | — |
Investigational sites
Hospital Edouard Herriot
Infectious disease, 5 Place D Arsonval, 69003, Lyon
Assistance Publique Hopitaux De Paris
Infectious disease, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Hospitalier Universitaire De Bordeaux
Infectious disease, Place Amelie Raba Leon, 33000, Bordeaux
Hopital De La Croix Rousse
Infectious disease, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Hôpital La Colombière
Infectious disease, 39 Avenue Charles Flahaut, 34090, Montpellier
Hopital Europeen Marseille
Infectious disease, 6 Rue Desiree Clary, 13003, Marseille
Centre Hospitalier Universitaire De Nantes
Infectious disease, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Bordeaux
Infectious disease, 1 Rue Jean Burguet, 33000, Bordeaux
Centre Hospitalier Universitaire De Nice
Infectious disease, 151 Route De Saint Antoine, 06200, Nice
Assistance Publique Hopitaux De Paris
Infectious disease, 125 Rue De Stalingrad, 93000, Bobigny
Centre Hospitalier Universitaire De Dijon
Infectious disease, 14 Rue Paul Gaffarel, 21000, Dijon
CHU De Rouen
Infectious disease, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Regional D'orleans
Infectious disease, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Centre Hospitalier De Tourcoing
Infectious disease, 155 Rue Du President Coty, Bp 40619, Tourcoing Cedex
Assistance Publique Hopitaux De Paris
Infectious disease, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Assistance Publique Hopitaux De Paris
Infectious disease, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Assistance Publique Hopitaux De Paris
Infectious disease, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Toulouse
Infectious disease, Place Du Docteur Joseph Baylac, 31000, Toulouse
Assistance Publique Hopitaux De Paris
Infectious disease, 4 Rue De La Chine, 75020, Paris
ICH Study Center GmbH & Co. KG
ICH Study Center GmbH & Co. KG, Grindelallee 35, Rotherbaum, Hamburg
Universitaetsklinikum Bonn AöR
Medizinische Klinik I - Klinisches Studienzentrum Immunologie, Venusberg-Campus 1, Venusberg, Bonn
Medizinische Hochschule Hannover
Klinik für Immunologie und Rheumatologi, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Klinikum Der Universitat Munchen AöR
Medizinische Klinik und Poliklinik IV Infektionsambulanz Poliklinik, Pettenkoferstrasse 8a, Ludwigsvorstadt-Isarvorstadt, Munich
Infektio Research GmbH & Co. KG
Infektio Research GmbH & Co. KG, Stresemannallee 3, Sachsenhausen, Frankfurt Am Main
MUC Research GmbH
MVZ München am Goetheplatz, Waltherstrasse 32, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsklinikum Essen AöR
Klinik für Dermatologie, Allergologie und Venerologie HPSTD-Ambulanz, Hufelandstrasse 55, Holsterhausen, Essen
Klinikum Rechts Der Isar Der TU Muenchen AöR
Klinik und Poliklinik für Innere Medizin, Ismaninger Strasse 22, Au-Haidhausen, Munich
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbh, Budapester Straße 15-19, Tiergarten, Berlin
zibp - Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH
zibp Zentrum für Infektiologie, Driesener Straße 23, Prenzlauer Berg, Berlin
University Medical Center Hamburg-Eppendorf
Infektiologie am Ambulanzzentrum, Martinistrasse 52, Eppendorf, Hamburg
Azienda Ospedaliera Papa Giovanni XXIII
Antiviral therapy Unit, Piazza Oms 1, 24127, Bergamo
ASST Fatebenefratelli Sacco
I Division Infectious disesas, Via Giovanni Battista Grassi 74, 20157, Milan
Fondazione IRCCS Policlinico San Matteo
Complex Operative Unit of Infectious disease I, Viale Camillo Golgi 19, 27100, Pavia
Ospedale San Raffaele S.r.l.
Infectious disease Division, Via Stamira D'ancona 20, 20127, Milan
Azienda Socio Sanitaria Territoriale Di Monza
Operative Unit of Infectious disesas, Via Giovanni Battista Pergolesi 33, 20900, Monza
National Institute For Infectious Diseases Lazzaro Spallanzani
Viral Immunodeficiency, Via Portuense 292, 00149, Rome
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
Clinic of Tropical Infective disease, Via Antonio Di Rudini' 8, 20142, Milan
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Complex Operative Unit of Infectious disease I, Via Francesco Sforza 28, 20122, Milan
Azienda Sanitaria Locale Citta Di Torino
Clinical Unit of Infectious diseases, Corso Svizzera 164, 10149, Turin
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Institute of Clinical Surgery of Infective Disease, Largo Francesco Vito 1, 00168, Rome
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
Oddział Chorób Zakaźnych i Hepatologii- F, Ul. Gen. Karola Kniaziewicza 1/5, 91-347, Lodz
Wroclawskie Centrum Zdrowia Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Ośrodek Profilaktyczno-Leczniczy Chorób Zakaźnych i Terapii Uzależnień, Ul Wszystkich Swietych 2, 50-136, Wroclaw
Wojewodzki Szpital Zakazny W Warszawie samodzielny publiczny zaklad opieki zdrowotnej
Pawilon VI, Ul. Wolska 37, 01-201, Warsaw
Emc Instytut Medyczny S.A.
ul. Łowiecka 24, 50-220 Wrocław, Przychodnia EuroMediCare, Wrocław Łowiecka, Ul. Pilczycka 144/148, 54-144, Wroclaw
Hospital Universitari Vall D Hebron
Infectious disease, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Bellvitge University Hospital
Infectious disease, Carretera De La Feixa Llarga S/n, Poligono Industrial De La Zona Ranca De Barcelona, L'hospitalet De Llobregat
Hospital Clinic De Barcelona
Infectious disease, Calle Villarroel 170, 08036, Barcelona
Hospital General Universitario De Elche
Infectious disease, Edificio 2, Camino De La Almazara 11, Elche
Hospital Universitario La Paz
Infectious disease, Paseo Castellana 261, 28046, Madrid
Hospital Universitari Germans Trias I Pujol
Infectious disease, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario 12 De Octubre
Infectious disease, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitario Ramon Y Cajal
Infectious disease, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital General Universitario Gregorio Maranon
Infectious disease, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Infanta Leonor
Infectious disease, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Infectious disease, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Virgen De La Victoria
Infectious disease, Calle Del Arroyo Teatinos S N, 29010, Malaga
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-10 | Italy | Not acceptable 2023-04-24
|
2023-04-28 |