Clinical trial • Phase II/III • Infectious Disease
ISLATRAVIR for HIV-1 infection
Phase II/III trial of ISLATRAVIR for HIV-1 infection.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- HIV-1 infection
- Trial Stage
- Phase II/III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 16-10-2025
- First CTIS Authorization Date
- 16-02-2026
Trial design
Randomised, open-label, bictegravir/emtricitabine/tenofovir alafenamide (bic/ftc/taf) once daily (comparator product: emtricitabine, tenofovir alafenamide and bictegravir; product record max daily dose amount: 275 mg).-controlled Phase II/III trial in France, Spain.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) once daily (comparator product: EMTRICITABINE, TENOFOVIR ALAFENAMIDE AND BICTEGRAVIR; product record max daily dose amount: 275 mg).
- Target Sample Size
- 450
- Trial Duration For Participant
- 672
Eligibility
Recruits 450 No vulnerable population selected (isVulnerablePopulationSelected: false). The study population is adults (treatment-naïve adult participants). Informed consent will be obtained from each participant. No information on assent or guardian consent is provided in the available data..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false). The study population is adults (treatment-naïve adult participants). Informed consent will be obtained from each participant. No information on assent or guardian consent is provided in the available data.
Inclusion criteria
- {"criterion_text":"- Is human immunodeficiency virus type 1 (HIV-1) positive with: - Phase 2: Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL. - Phase 3: Plasma HIV-1 RNA ≥500 copies/mL."}
- {"criterion_text":"- Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells/mm^3."}
- {"criterion_text":"- Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection."}
Exclusion criteria
- {"criterion_text":"- Has human immunodeficiency virus type 2 (HIV-2) infection."}
- {"criterion_text":"- Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection."}
- {"criterion_text":"- Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection."}
- {"criterion_text":"- Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or in situ anal cancer, or cutaneous Kaposi’s sarcoma."}
- {"criterion_text":"- Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24","definition_or_measurement_approach":"Measured as the percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 24."}
- {"endpoint_text":"- Phase 2: Percentage of Participants Who Experience an Adverse Event (AE) at Week 24","definition_or_measurement_approach":"Measured as the percentage of participants reporting any adverse event by Week 24."}
- {"endpoint_text":"- Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24","definition_or_measurement_approach":"Measured as the percentage of participants who discontinue study intervention because of an AE by Week 24."}
- {"endpoint_text":"- Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48","definition_or_measurement_approach":"Measured as the percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48."}
- {"endpoint_text":"- Phase 3: Percentage of Participants Who Experience an AE at Week 48","definition_or_measurement_approach":"Measured as the percentage of participants reporting any adverse event by Week 48."}
- {"endpoint_text":"- Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 48","definition_or_measurement_approach":"Measured as the percentage of participants who discontinue study intervention because of an AE by Week 48."}
Secondary endpoints
- {"endpoint_text":"- Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48","definition_or_measurement_approach":"Measured as the percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48."}
- {"endpoint_text":"- Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96","definition_or_measurement_approach":"Measured as the percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 96."}
- {"endpoint_text":"- Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 24","definition_or_measurement_approach":"Measured as the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 24."}
- {"endpoint_text":"- Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48","definition_or_measurement_approach":"Measured as the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 48."}
- {"endpoint_text":"- Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96","definition_or_measurement_approach":"Measured as the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 96."}
- {"endpoint_text":"- Phase 2: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 24","definition_or_measurement_approach":"Measured as mean change from baseline in CD4+ T-cell count at Week 24."}
- {"endpoint_text":"- Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 48","definition_or_measurement_approach":"Measured as mean change from baseline in CD4+ T-cell count at Week 48."}
- {"endpoint_text":"- Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 96","definition_or_measurement_approach":"Measured as mean change from baseline in CD4+ T-cell count at Week 96."}
- {"endpoint_text":"- Phase 2: Percentage of Participants Who Experience an AE","definition_or_measurement_approach":"Measured as the percentage of participants reporting any adverse event during Phase 2."}
- {"endpoint_text":"- Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":"Measured as the percentage of participants who discontinue study intervention due to an AE during Phase 2."}
- {"endpoint_text":"- Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 24","definition_or_measurement_approach":"Measured as the count of participants with resistance-associated substitutions at Week 24."}
- {"endpoint_text":"- Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48","definition_or_measurement_approach":"Measured as the count of participants with resistance-associated substitutions at Week 48."}
- {"endpoint_text":"- Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96","definition_or_measurement_approach":"Measured as the count of participants with resistance-associated substitutions at Week 96."}
- {"endpoint_text":"- Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96","definition_or_measurement_approach":"Measured as the percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 96."}
- {"endpoint_text":"- Phase 3: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48","definition_or_measurement_approach":"Measured as the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 48."}
- {"endpoint_text":"- Phase 3: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96","definition_or_measurement_approach":"Measured as the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 96."}
- {"endpoint_text":"- Phase 3: Mean Change From Baseline in CD4+ T-Cell Count at Week 48","definition_or_measurement_approach":"Measured as mean change from baseline in CD4+ T-cell count at Week 48."}
- {"endpoint_text":"- Phase 3: Mean Change From Baseline in CD4+ T-Cell Count at Week 96","definition_or_measurement_approach":"Measured as mean change from baseline in CD4+ T-cell count at Week 96."}
- {"endpoint_text":"- Phase 3: Percentage of Participants Who Experience an AE","definition_or_measurement_approach":"Measured as the percentage of participants reporting any adverse event during Phase 3."}
- {"endpoint_text":"- Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":"Measured as the percentage of participants who discontinue study intervention due to an AE during Phase 3."}
- {"endpoint_text":"- Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48","definition_or_measurement_approach":"Measured as the count of participants with resistance-associated substitutions at Week 48."}
- {"endpoint_text":"- Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96","definition_or_measurement_approach":"Measured as the count of participants with resistance-associated substitutions at Week 96."}
- {"endpoint_text":"- Phase 3: Mean Change From Baseline in Body Weight at Week 48","definition_or_measurement_approach":"Measured as mean change from baseline in body weight at Week 48."}
- {"endpoint_text":"- Phase 3: Mean Change From Baseline in Body Weight at Week 96","definition_or_measurement_approach":"Measured as mean change from baseline in body weight at Week 96."}
Recruitment
- Planned Sample Size
- 450
- Recruitment Window Months
- 50
- Consent Approach
- Informed consent will be obtained from each participant. Subject information and informed consent form documents are provided for member states (French and Spanish ICFs are listed). Optional ICFs for pregnancy and infant follow-up are included in the documentation. No specific assent procedures are indicated in the available data.
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 70
France
- Earliest CTIS Part Ii Submission Date
- 27-11-2025
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 81
- Number Of Sites
- 12
- Number Of Participants
- 35
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Jade Ghosn
- Principal Investigator Email
- jade.ghosn@aphp.fr
- Contact Person Name
- Jade Ghosn
- Contact Person Email
- jade.ghosn@aphp.fr
- Site Name
- Centre Hospitalier De Tourcoing
- Department Name
- Service des Maladies Infectieuses et du Voyageur
- Principal Investigator Name
- Emmanuelle Aïssi
- Principal Investigator Email
- eaissi@ch-tourcoing.fr
- Contact Person Name
- Emmanuelle Aïssi
- Contact Person Email
- eaissi@ch-tourcoing.fr
- Site Name
- Hopital Saint Louis
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Jean-Michel Molina
- Principal Investigator Email
- jean-michel.molina@aphp.fr
- Contact Person Name
- Jean-Michel Molina
- Contact Person Email
- jean-michel.molina@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Pierre Delobel
- Principal Investigator Email
- delobel.p@chu-toulouse.fr
- Contact Person Name
- Pierre Delobel
- Contact Person Email
- delobel.p@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Alain Makinson
- Principal Investigator Email
- a-makinson@chu-montpellier.fr
- Contact Person Name
- Alain Makinson
- Contact Person Email
- a-makinson@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Eric Cua
- Principal Investigator Email
- cua.e@chu-nice.fr
- Contact Person Name
- Eric Cua
- Contact Person Email
- cua.e@chu-nice.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Nicolas Vignier
- Principal Investigator Email
- nicolas.vignier@aphp.fr
- Contact Person Name
- Nicolas Vignier
- Contact Person Email
- nicolas.vignier@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service d'immunologie et maladies infectieuses
- Principal Investigator Name
- Sébastien Gallien
- Principal Investigator Email
- sebastien.gallien@aphp.fr
- Contact Person Name
- Sébastien Gallien
- Contact Person Email
- sebastien.gallien@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Paul Loubet
- Principal Investigator Email
- paul.loubet@chu-nimes.fr
- Contact Person Name
- Paul Loubet
- Contact Person Email
- paul.loubet@chu-nimes.fr
- Site Name
- Hospital Hotel Dieu
- Department Name
- Service des Maladies Infectieuses
- Principal Investigator Name
- Colin Deschanvres
- Principal Investigator Email
- colin.deschanvres@chu-nantes.fr
- Contact Person Name
- Colin Deschanvres
- Contact Person Email
- colin.deschanvres@chu-nantes.fr
- Site Name
- Hospital La Croix Rousse Hcl
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Matthieu Godinot
- Principal Investigator Email
- matthieu.godinot@chu-lyon.fr
- Contact Person Name
- Matthieu Godinot
- Contact Person Email
- matthieu.godinot@chu-lyon.fr
- Site Name
- Pellegrin Hospital
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Charles Cazanave
- Principal Investigator Email
- Charles.cazanave@chu-bordeaux.fr
- Contact Person Name
- Charles Cazanave
- Contact Person Email
- Charles.cazanave@chu-bordeaux.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 04-12-2025
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 81
- Number Of Sites
- 13
- Number Of Participants
- 35
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- Servicio Enfermedades Infecciosas
- Principal Investigator Name
- José Ignacio Bernardino
- Principal Investigator Email
- naberse@gmail.com
- Contact Person Name
- José Ignacio Bernardino
- Contact Person Email
- naberse@gmail.com
- Site Name
- Bellvitge University Hospital
- Department Name
- Servicio Enfermedades Infecciosas
- Principal Investigator Name
- Arkaitz Imaz Vacas
- Principal Investigator Email
- aimaz@bellvitgehospital.cat
- Contact Person Name
- Arkaitz Imaz Vacas
- Contact Person Email
- aimaz@bellvitgehospital.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio Enfermedades Infecciosas
- Principal Investigator Name
- Paula Suances Díez
- Principal Investigator Email
- paula.suanzes@vallhebron.cat
- Contact Person Name
- Paula Suances Díez
- Contact Person Email
- paula.suanzes@vallhebron.cat
- Site Name
- Consorcio Hospital General Universitario De Valencia
- Department Name
- Servicio Enfermedades Infecciosas
- Principal Investigator Name
- Miguel García del Toro
- Principal Investigator Email
- gdeltoromiguel@gmail.com
- Contact Person Name
- Miguel García del Toro
- Contact Person Email
- gdeltoromiguel@gmail.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Servicio Enfermedades Infecciosas
- Principal Investigator Name
- José Moltó Marhuenda
- Principal Investigator Email
- jmolto@lluita.org
- Contact Person Name
- José Moltó Marhuenda
- Contact Person Email
- jmolto@lluita.org
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio Enfermedades Infecciosas
- Principal Investigator Name
- Otilia Bisbal Pardo
- Principal Investigator Email
- otibisbi@gmail.com
- Contact Person Name
- Otilia Bisbal Pardo
- Contact Person Email
- otibisbi@gmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Servicio Enfermedades Infecciosas
- Principal Investigator Name
- Francisco Tejerina Picado
- Principal Investigator Email
- pacotejerina@gmail.com
- Contact Person Name
- Francisco Tejerina Picado
- Contact Person Email
- pacotejerina@gmail.com
- Site Name
- Hospital General Universitario De Elche
- Department Name
- Servicio Enfermedades Infecciosas
- Principal Investigator Name
- Félix Gutierrez Rodero
- Principal Investigator Email
- gutierrez_fel@gva.es
- Contact Person Name
- Félix Gutierrez Rodero
- Contact Person Email
- gutierrez_fel@gva.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Servicio Enfermedades Infecciosas
- Principal Investigator Name
- Alfonso Cabello Ubeda
- Principal Investigator Email
- acabello@fjd.es
- Contact Person Name
- Alfonso Cabello Ubeda
- Contact Person Email
- acabello@fjd.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Servicio Enfermedades Infecciosas
- Principal Investigator Name
- Josep Mallolas Masferrer
- Principal Investigator Email
- mallolas@clinic.cat
- Contact Person Name
- Josep Mallolas Masferrer
- Contact Person Email
- mallolas@clinic.cat
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Servicio Enfermedades Infecciosas
- Principal Investigator Name
- Rosario Palacios Muñoz
- Principal Investigator Email
- rosariopalaci@gmail.com
- Contact Person Name
- Rosario Palacios Muñoz
- Contact Person Email
- rosariopalaci@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Servicio Enfermedades Infecciosas
- Principal Investigator Name
- Santiago Moreno Guillén
- Principal Investigator Email
- smguillen@salud.madrid.org
- Contact Person Name
- Santiago Moreno Guillén
- Contact Person Email
- smguillen@salud.madrid.org
- Site Name
- Hospital General Universitario Santa Lucia
- Department Name
- Servicio Medicina Interna
- Principal Investigator Name
- Francisco Jesús Vera Méndez
- Principal Investigator Email
- franciscovera72@gmail.com
- Contact Person Name
- Francisco Jesús Vera Méndez
- Contact Person Email
- franciscovera72@gmail.com
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)
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- sponsorDuties code: 4 (contracted services)
- Name
- Syneos Health Clinique Inc.
- Responsibilities
- sponsorDuties code: 4 (contracted services)
- Name
- Eresearchtechnology Inc.
- Responsibilities
- sponsorDuties code: 7 (roles provided in record)
Third parties
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: 4 (contact details provided)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services) (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Monogram Biosciences Inc.","duties_or_roles":"sponsorDuties codes: 4 (contact details provided)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- islatravir
- Active Substance
- ISLATRAVIR
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Frequency
- Once weekly (as part of ISL+ULO qw in study arms)
- Maximum Dose
- 2 mg (maxDailyDoseAmount from product record)
- Investigational Product Name
- ulonivirine
- Active Substance
- ULONIVIRINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Frequency
- Once weekly (as part of ISL+ULO qw in study arms)
- Maximum Dose
- 200 mg (maxDailyDoseAmount from product record)
- Investigational Product Name
- MK-8591B
- Active Substance
- ISLATRAVIR, ULONIVIRINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Frequency
- Once weekly (MK-8591B = combination ISL+ULO qw per protocol title)
- Maximum Dose
- 202 mg (maxDailyDoseAmount from product record)
- Investigational Product Name
- islatravir (capsule) [MK-8591]
- Active Substance
- ISLATRAVIR
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 2 mg (product record maxDailyDoseAmount)
- Investigational Product Name
- ulonivirine (tablet) [MK-8507]
- Active Substance
- ULONIVIRINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 200 mg (product record maxDailyDoseAmount)
- Investigational Product Name
- EMTRICITABINE, TENOFOVIR ALAFENAMIDE AND BICTEGRAVIR (BIC/FTC/TAF)
- Active Substance
- EMTRICITABINE; TENOFOVIR ALAFENAMIDE; BICTEGRAVIR
- Modality
- Small molecule (combination antiretroviral)
- Routes Of Administration
- ORAL
- Route
- ORAL
- Frequency
- Once daily (comparator arm)
- Maximum Dose
- 275 mg (product record maxDailyDoseAmount)
- Investigational Product Name
- Placebo to BIK/FTC/TAF
- Modality
- Other
- Investigational Product Name
- Placebo to 8591B
- Modality
- Other
- Combination Treatment
- Yes
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