Clinical trial • Phase III • Infectious Disease

Doravirine; Islatravir for HIV-1 infection|HIV infection

Phase III trial of Doravirine; Islatravir for HIV-1 infection|HIV infection. open-label. 522 participants.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
HIV-1 infection|HIV infection
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
24-05-2024
First CTIS Authorization Date
01-07-2024

Trial design

open-label Phase III trial across 7 sites in Italy, France.

Open Label
Yes
Target Sample Size
522

Eligibility

Recruits 522 No vulnerable populations selected (isVulnerablePopulationSelected:false). Informed consent forms are provided; no assent/minor consent procedures are specified in the registry data..

Pregnancy Exclusion
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).
Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected:false). Informed consent forms are provided; no assent/minor consent procedures are specified in the registry data.

Inclusion criteria

  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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

  • {"criterion_text":"- Is taking or is anticipated to require any prohibited therapies."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of participants with serious adverse events (SAEs)","definition_or_measurement_approach":"Measured as the percentage (proportion) of participants with serious adverse events (SAEs)."}
  • {"endpoint_text":"- Percentage of participants who discontinued study treatment due to an adverse event (AE)","definition_or_measurement_approach":"Measured as the percentage (proportion) of participants who discontinued study treatment because of an adverse event (AE)."}

Recruitment

Planned Sample Size
522
Recruitment Window Months
90
Consent Approach
Informed consent obtained from participants via subject ICFs. Subject information and informed consent form documents are available (Italian and French versions listed: e.g. L1_ICF_Main consent_ITA_IT_SM05_for pub, L1_ICF_Main consent_FRA_FR_SM06_for pub, and optional extension period ICFs). Participants are adults; no assent/minor consent procedures are specified in the registry data.

Geography

Total Number Of Sites
7
Total Number Of Participants
84

Italy

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
619
Number Of Sites
2
Number Of Participants
40

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento Malattie Infettive
Contact Person Name
Antonella Castagna
Contact Person Email
castagna.antonella1@hsr.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Dipartimento Malattie Infettive
Contact Person Name
Roberto Gulminetti
Contact Person Email
r.gulminetti@smatteo.pv.it

France

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
03-03-2026
Processing Time Days
638
Number Of Sites
5
Number Of Participants
44

Sites

Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Département des maladies infectieuses et tropicales
Contact Person Name
Alain MAKINSON
Contact Person Email
a-makinson@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service de médecine interne et maladies infectieuses
Contact Person Name
Mojgan HESSAMFAR
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service des maladies infectieuses et tropicales
Contact Person Name
Jade GHOSN
Contact Person Email
jade.ghosn@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service des Maladies Infectieuses et Tropicales
Contact Person Name
Jean-Michel MOLINA
Contact Person Email
jean-michel.molina@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service des maladies infectieuses et tropicales
Contact Person Name
Eric CUA
Contact Person Email
cua.e@chu-nice.fr

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)

Third parties

  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MK-8591A
Active Substance
Doravirine; Islatravir
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
prodAuthStatus:1
Starting Dose
Doravirine 100 mg / Islatravir 0.75 mg (fixed-dose combination)
Frequency
Once daily
Maximum Dose
100.75 mg
Combination Treatment
Yes

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