Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
606
Countries
2
Sites
7
HIV infection
1. To evaluate the safety and tolerability of Doravirine/Islatravir (DOR/ISL) as assessed by accumulated safety data.
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]
- Trial duration
- 27 Oct 2021 → ongoing
- Decision date (initial)
- 2024-07-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2024-512215-53-00
- EudraCT number
- 2020-001191-14
- WHO UTN
- U1111-1304-7926
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacokinetic, Safety
1. To evaluate the safety and tolerability of Doravirine/Islatravir (DOR/ISL) as assessed by accumulated safety data.
Conditions and MedDRA coding
HIV infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10068341 | HIV-1 infection | 10021881 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Is currently receiving DOR 100 mg/ISL 0.75 mg adult fixed dose combination (FDC) tablet in an MSD-sponsored clinical study and has completed the last treatment visit.
- Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL is considered clinically appropriate.
- Female is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); or is a non-pregnant WOCBP who agrees to the following during the intervention period and for at least 6 weeks after the last dose of study intervention: Not be sexually active, or if sexually active, to use an acceptable method of contraception; or is pregnant and continues to receive study intervention (where allowed by local regulations and as appropriate based on available data/local standard-of-care guidelines).
Exclusion criteria 1
- Is taking or is anticipated to require any prohibited therapies.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Percentage of participants with serious adverse events (SAEs)
- Percentage of participants who discontinued study treatment due to an adverse event (AE)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9392072 · Product
- Active substance
- Doravirine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100.75 mg milligram(s)
- Max total dose
- 203112 mg milligram(s)
- Max treatment duration
- 288 Week(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, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Mengchun Li
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Mengchun Li
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Interactive response technologies (IRT) |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
Locations
2 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 44 | 5 |
| Italy | Ongoing, recruitment ended | 40 | 2 |
| Rest of world
Colombia, United States, South Africa, Australia, Switzerland, United Kingdom, Japan, Chile, Canada, New Zealand, Russian Federation
|
— | 522 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Service des Maladies Infectieuses et Tropicales, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Bordeaux
Service de médecine interne et maladies infectieuses, 1 Rue Jean Burguet, 33000, Bordeaux
Assistance Publique Hopitaux De Paris
Service des maladies infectieuses et tropicales, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Centre Hospitalier Universitaire De Nice
Service des maladies infectieuses et tropicales, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Montpellier
Département des maladies infectieuses et tropicales, 39 Avenue Charles Flahault, Pavillon 32, Montpellier Cedex 5
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2021-10-27 | 2021-11-04 | 2024-06-26 | ||
| Italy | 2022-05-17 | 2022-05-23 | 2024-06-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 18 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-512215-53_SM07_for pub | 13 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_SM07_for pub | 06JAN2026 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_for pub | 04JUL2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_FRA_FR_for pub | 26MAY2021R |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_FRA_FR_for pub | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_FRA_FR_SM07_for pub | AM07v7.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FRA_FR_SM06_for pub | AM06v6.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_SM05_for pub | AM05 v5.03 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_Adult_ITA_IT_for pub | 20JUN2024 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_extension period_FRA_FR_for pub | AM01_v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_extension period_ITA_IT_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_second extension period_FRA_FR_SM06_RFI001_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Second extension period_ITA_IT_SM06_for pub | 00 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-512215-53_FRA_FR_SM07_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-512215-53_ITA_IT_SM07_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2024-512215-53_SM07_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2024-512215-53_FRA_FR_for pub | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2024-512215-53_ITA_IT_for pub | 4.0 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-24 | France | Acceptable 2024-07-01
|
2024-07-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-16 | France | Acceptable 2024-08-23
|
2024-08-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-25 | France | Acceptable 2024-11-06
|
2024-11-06 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-22 | France | Acceptable 2024-11-06
|
2024-11-22 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-20 | France | Acceptable 2024-11-06
|
2025-02-20 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-14 | Acceptable | 2025-05-16 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-19 | France | Acceptable | 2025-04-15 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-05-21 | France | Acceptable 2025-08-13
|
2025-08-18 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-15 | France | Acceptable 2025-10-30
|
2025-11-03 |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-01-15 | France | Acceptable 2026-03-02
|
2026-03-03 |