Clinical trial • Phase II • Infectious Disease

VH4524184 for HIV-1 infection

Phase II trial of VH4524184 for HIV-1 infection.

Overview

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

Key dates

Initial CTIS Submission Date
22-09-2025
First CTIS Authorization Date
23-01-2026

Trial design

Randomised, open-label, dovato (dtg/3tc fixed-dose combination) 50 mg/300 mg film-coated tablets; oral control arm (administered as per standard oral daily dosing as control arm in study). Phase II trial across 78 sites in Spain, Belgium, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Dovato (DTG/3TC fixed-dose combination) 50 mg/300 mg film-coated tablets; oral control arm (administered as per standard oral daily dosing as control arm in study).
Target Sample Size
265
Trial Duration For Participant
730

Eligibility

Recruits 265 Vulnerable population selected. Participants must be 'Capable of giving signed informed consent' (per inclusion criterion). Subject information and informed consent documents are provided (e.g., L1_ICF_Main, L1_ICF_Pregnant participant, L1_ICF_Holders of parental authority); consent is obtained from the participant via signed ICF. (ICF documents available in multiple language versions)..

Pregnancy Exclusion
Participants who are breastfeeding or plan to breastfeed during the study.
Vulnerable Population
Vulnerable population selected. Participants must be 'Capable of giving signed informed consent' (per inclusion criterion). Subject information and informed consent documents are provided (e.g., L1_ICF_Main, L1_ICF_Pregnant participant, L1_ICF_Holders of parental authority); consent is obtained from the participant via signed ICF. (ICF documents available in multiple language versions).

Inclusion criteria

  • {"criterion_text":"- Participant must be at least 18 years of age (or older, if required for adults by local regulations) at the time of signing the informed consent.\n- Screening CD4+ T-cell count greater than or equal to 200 cells/µL.\n- Documented HIV-1 infection and Screening plasma HIV-1 RNA of ≥1000 copies/mL. A single repeat of this test is allowed within a single Screening period to determine eligibility.\n- Treatment-naïve: Defined as no ARVs (in combination or monotherapy) received after the diagnosis of HIV-1 infection. The prior use of oral pre-exposure prophylaxis or oral post-exposure prophylaxis is permitted and meets inclusion. (Note: Prior use of LA CAB is exclusionary)\n- France: Participants enrolled in France must be affiliated with, or be a beneficiary of a social security system\n- Body weight greater than or equal to 50.0 kg (110 lbs) for participants assigned male at birth and greater than or equal to 45.0 kg (99 lbs) for participants assigned female at birth. BMI within the range 18.5-35.5 kg/m2 (inclusive - applies to males and females).\n- There are no contraceptive requirements for participants assigned male at birth.\n- Participants assigned female at birth are eligible to participate if they are not pregnant and not breastfeeding and one of the following conditions applies: •\tIs a PONCBP; OR •\tIs a POCBP and using a contraceptive method that is highly effective, with a failure rate of <1% (see Section 10.4.2) prior to and during the study intervention period, and for at least 1 week after the last dose of VH4524184 plus FTC/TAF FDC, or through the end of study (if in the control arm and never received VH4524184). The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention. -\tA POCBP must have a negative highly sensitive pregnancy test at Screening (serum) and on Day 1 (urine) before the first dose of study intervention. -\tIf 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. -\tThe investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of an individual with an early undetected pregnancy.\n- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and stated in this protocol."}

Exclusion criteria

  • {"criterion_text":"- Participants who are breastfeeding or plan to breastfeed during the study.\n- ALT > or = 3 times the ULN. A single repeat of ALT is allowed within a single screening period to determine eligibility.\n- Any Grade 4 laboratory abnormality at Screening, except for a Grade 4 CPK and lipid abnormalities (e.g., total cholesterol, triglycerides, etc.) will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the ViiV Healthcare medical monitor. A single repeat of any lab abnormality is allowed within a single screening period to determine eligibility.\n- Participants who in the investigator’s judgment, pose a significant suicidality risk. Participant’s history of suicidal behavior and/or suicidal ideation (as measured with the C-SSRS prior to dosing) should be considered when evaluating suicide risk.\n- Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.\n- Any evidence of an active CDC Stage 3 disease [CDC 2014], except cutaneous Kaposi’s sarcoma not requiring systemic therapy during the study. Historical CD4+ cell counts less than 200 cells/µL are not exclusionary.\n- Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination and will be the screening ECG entered into the eCRF): QT interval corrected for heart rate according to Fridericia’s formula (QTcF) >450 msec (males) or >470 msec (females); >480 msec for participants with bundle branch block.\n- Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).\n- Known history of cirrhosis with or without viral hepatitis co-infection.\n- Participants with HCV co-infection will be excluded from the study.\n- Individuals who are co-infected with HIV and HBV will be excluded. Exclusion will be determined by evidence of HBV infection based on the results of testing at Screening for HBsAg, HBcAb, HBsAb and HBV DNA as follows: a.\tParticipants positive for HBsAg are excluded; b.\tParticipants negative for HBsAb and negative for HBsAg but positive for HBcAb may be excluded based on the following. Consideration: i.\tExclude if HBV DNA is detected (either < LLOQ, > ULOQ OR numerical value [ie, between LLOQ and ULOQ]) ii.\tNot excluded if HBV DNA is negative, not detected Note: Participants positive for HBcAb, negative for HBsAg and positive for HBsAb (past and/or current evidence, e.g., at screening) are considered to be immune to HBV and are not excluded.\n- Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 30 days of Day 1.\n- Participants diagnosed with syphilis at Screening (i.e., positive syphilis testing) should be treated as per local guidelines and will be eligible to enroll at any time regardless of the stage of disease. When RPR or VDRL titers are high (i.e., ≥1:256), investigators should consider syphilis treatment before study enrollment, but may enroll 48 hours after treatment initiation.\n- Uncontrolled malignancy is excluded, whereas participants who have controlled malignancies may be included in agreement between the investigator and the ViiV Healthcare medical monitor.\n- Any pre-existing physical, or mental condition (including alcohol or drug abuse) which, in the opinion of the investigator (with or without psychiatric evaluation) or the ViiV Healthcare medical monitor, may interfere with the participant’s ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.\n- Any condition which, in the opinion of the investigator or the ViiV Healthcare medical monitor, may interfere with the absorption, distribution, metabolism or excretion of the study interventions or render the participant unable to take oral medication.\n- A pre-existing condition, in the opinion of the investigator or ViiV Healthcare medical monitor, that could interfere with normal gastrointestinal anatomy or motility (e.g., gastroesophageal reflux disease, gastric ulcers, gastritis, inflammatory bowel disease) or hepatic and/or renal function\n- Clinically significant CV disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.\n- History of sensitivity to any of the study medications, or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or ViiV Healthcare medical monitor, contraindicates their participation.\n- Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (≤325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.\n- Treatment with any of the following agents within 60 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant.\n- Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.\n- Participants with acute HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc.) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion.\n- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening\n- Exposure to an investigational drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study intervention.\n- Exposure to an approved vaccine within 14 days prior to Day 1.\n- Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research.\n- Participants with known or suspected presence of virologic resistance mutations as defined by the Stanford HIV Drug Resistance Database to INSTIs or NRTIs. This determination will be based on local virologic resistance testing, either at Screening or within the 3 months prior to Screening. ViiV Healthcare clinical virologist and/or ViiV Healthcare medical monitor will verify eligibility to this criterion prior to Day 1.\n- Creatinine clearance (eGFR) of <60 mL/min/1.73 m2 via CKD-EPI race neutral method [Delgado, 2021]. •\tJapan: For Japanese participants enrolled at sites in Japan, the eGFR will be calculated using the serum creatinine-based Japanese eGFR estimation formula (JSN eGFRcr) recommended by the Japanese Society of Nephrology [Japanese Society of Nephrology, 2024]."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Plasma HIV-1 RNA <50 copies/mL (FDA snapshot) at Month 12","definition_or_measurement_approach":"Measured as plasma HIV-1 RNA <50 copies/mL using the FDA snapshot approach (as stated: \"(FDA snapshot)\")."}

Secondary endpoints

  • {"endpoint_text":"- •\tPlasma HIV-1 RNA <50 copies/mL (observed) until Month 24. •\tPlasma HIV-1 RNA <50 copies/mL (FDA snapshot) until Month 24.","definition_or_measurement_approach":"Virologic suppression measured as plasma HIV-1 RNA <50 copies/mL both by observed analysis and FDA snapshot approach through Month 24."}
  • {"endpoint_text":"- Change from baseline in CD4+ T-cell count until Month 24.","definition_or_measurement_approach":"Absolute change from baseline in CD4+ T-cell count measured at scheduled visits up to Month 24."}
  • {"endpoint_text":"- To assess the safety and tolerability of oral VH4524184 containing regimens compared to the DTG/3TC FDC oral control arm","definition_or_measurement_approach":"Safety and tolerability assessed by adverse event reporting, clinical laboratory tests, vital signs and other safety assessments as per protocol."}
  • {"endpoint_text":"- To assess the PK of VH4524184 during the Treatment Period","definition_or_measurement_approach":"Pharmacokinetic (PK) sampling and analysis of VH4524184 during the Treatment Period as specified in the protocol."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
265
Recruitment Window Months
32
Consent Approach
Informed consent is obtained via a signed informed consent form; inclusion criterion requires participants be 'Capable of giving signed informed consent'. Multiple ICF documents are provided (L1_ICF_Main, L1_ICF_Pregnant participant, L1_ICF_Treatment Restart, L1_ICF_PK sub-study, and language-specific anonymized ICFs). ICFs and participant information materials are available in multiple languages (EN, FR, NL, PT, PL, DE, IT and others as per country-specific documents). A document addressing 'Holders of parental authority' is present in the repository, though participants must be ≥18 per inclusion criteria.

Methods

  • Use of printed recruitment materials: posters and flyers (K2_Recruitment Poster, K2_Recruitment flyer) targeted to potential participants at study sites.
  • Patient-facing brochures and study introduction materials (K2_Study Introduction Flip Chart, K2_Study Patient Brochure) for in-clinic recruitment and explanation to potential participants.
  • Patient recruitment letters (K2_Patient Recruitment Letter) sent to potential participants or used by site staff to invite eligible patients.
  • Digital recruitment materials: digital patient brochure and digital study introduction materials (K2_Understanding the Study Patient Digital Brochure, K2_Understanding study pt digital brochure) for electronic distribution.
  • Visit schedules, IP bag overviews and post-consent participant guides (K2_Visit Schedule, K2_IP bag overview, K2_Post consent participant guide) used to explain study procedures and logistics at sites.
  • Materials were prepared in multiple language versions and country-specific versions (documents exist in EN, FR, NL, PT, PL, DE, IT and country-specific recruitment arrangements files for Spain, Belgium, France, Germany, Italy, Portugal, Poland).

Geography

Total Number Of Sites
78
Total Number Of Participants
175

Spain

Earliest CTIS Part Ii Submission Date
10-12-2025
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
44
Number Of Sites
35
Number Of Participants
114

Sites

Site Name
Hospital Universitario Reina Sofia
Department Name
Serivicio de enfermedades infecciosas
Principal Investigator Name
Enrique Bernal Morell
Principal Investigator Email
enrique.bernal@um.es
Contact Person Name
Enrique Bernal Morell
Contact Person Email
enrique.bernal@um.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Servicio de Medicina Interna
Principal Investigator Name
Pere Domingo Pedrol
Principal Investigator Email
PDomingo@santpau.cat
Contact Person Name
Pere Domingo Pedrol
Contact Person Email
PDomingo@santpau.cat
Site Name
Parc Sanitari Sant Joan De Deu
Department Name
Servicio de Infecciosas
Principal Investigator Name
Vicente Diaz De Brito Fernandez
Principal Investigator Email
vicente.diaz@pssjd.org
Contact Person Name
Vicente Diaz De Brito Fernandez
Contact Person Email
vicente.diaz@pssjd.org
Site Name
Hospital Del Mar
Department Name
Servicio de Infecciosas
Principal Investigator Name
Roberto Güerri - Fernández
Principal Investigator Email
rguerri@psmar.cat
Contact Person Name
Roberto Güerri - Fernández
Contact Person Email
rguerri@psmar.cat
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Servicio de enfermedades Infecciosas
Principal Investigator Name
Luis Fernando López Cortes
Principal Investigator Email
luisfernando@lopezcortes.net
Contact Person Name
Luis Fernando López Cortes
Contact Person Email
luisfernando@lopezcortes.net
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Servicio de enfermedades Infecciosas
Principal Investigator Name
Carmen Hidalgo Tenorio
Principal Investigator Email
chidalgo72@gmail.com
Contact Person Name
Carmen Hidalgo Tenorio
Contact Person Email
chidalgo72@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Servicio de Medicina Interna
Principal Investigator Name
Eugenia Negredo Puigmal
Principal Investigator Email
enegredo@lluita.org
Contact Person Name
Eugenia Negredo Puigmal
Contact Person Email
enegredo@lluita.org
Site Name
Hospital Universitario Virgen De Valme
Department Name
Servicio de enfermedades Infecciosas
Principal Investigator Name
Juan Macías Sánchez
Principal Investigator Email
jmacias7@us.es
Contact Person Name
Juan Macías Sánchez
Contact Person Email
jmacias7@us.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Servicio de Infecciosas
Principal Investigator Name
Marta Montero Alonso
Principal Investigator Email
montero_mar@gva.es
Contact Person Name
Marta Montero Alonso
Contact Person Email
montero_mar@gva.es
Site Name
Hospital Clinic De Barcelona
Department Name
Servicio de VIH-SIDA
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 General Universitario Dr. Balmis
Department Name
Servicio de enfermedades Infecciosas
Principal Investigator Name
Sergio Reus Bañuls
Principal Investigator Email
reus_ser@gva.es
Contact Person Name
Sergio Reus Bañuls
Contact Person Email
reus_ser@gva.es
Site Name
Parc Tauli Hospital Universitari
Department Name
Servicio de enfermedades infecciosas
Principal Investigator Name
Mª Carmen Navarro Sáez
Principal Investigator Email
mnavarros@tauli.cat
Contact Person Name
Mª Carmen Navarro Sáez
Contact Person Email
mnavarros@tauli.cat
Site Name
Hospital Universitario Torrecardenas
Department Name
Servicio de Medicina Interna
Principal Investigator Name
Antonio Collado Romacho
Principal Investigator Email
antonior.collado.sspa@juntadeandalucia.es
Contact Person Name
Antonio Collado Romacho
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Servicio de Medicina Interna
Principal Investigator Name
Alvaro Mena de Cea
Principal Investigator Email
Alvaro.Mena.de.Cea@sergas.es
Contact Person Name
Alvaro Mena de Cea
Contact Person Email
Alvaro.Mena.de.Cea@sergas.es
Site Name
Hospital Alvaro Cunqueiro
Department Name
Servicio de infecciosas
Principal Investigator Name
Luis Enrique Morano Amado
Principal Investigator Email
luis.morano.amado@gmail.com
Contact Person Name
Luis Enrique Morano Amado
Contact Person Email
luis.morano.amado@gmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Servicio de Infecciosas
Principal Investigator Name
Miguel Górgolas Hernández-Mora
Principal Investigator Email
mgorgolas@fjd.es
Contact Person Name
Miguel Górgolas Hernández-Mora
Contact Person Email
mgorgolas@fjd.es
Site Name
Consorcio Hospital General Universitario De Valencia
Department Name
Servicio de enfermedades Infecciosas
Principal Investigator Name
Miguel García Deltoro
Principal Investigator Email
garcia_migdel@gva.es
Contact Person Name
Miguel García Deltoro
Contact Person Email
garcia_migdel@gva.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Servicio de 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 Universitario 12 De Octubre
Department Name
Servicio de Medicina Interna
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 Universitario Infanta Leonor
Department Name
Servicio de Medicina Interna
Principal Investigator Name
Guillermo Cuevas Tascón
Principal Investigator Email
guillermocuevastascon@gmail.com
Contact Person Name
Guillermo Cuevas Tascón
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de enfermedades infecciosas
Principal Investigator Name
Jordi Navarro Mercade
Principal Investigator Email
jordi.navarro@vallhebron.cat
Contact Person Name
Jordi Navarro Mercade
Contact Person Email
jordi.navarro@vallhebron.cat
Site Name
Hospital Clinico San Carlos
Department Name
Servicio de Infecciosas
Principal Investigator Name
Vicente Estrada Pérez
Principal Investigator Email
vicente.estrada@salud.madrid.org
Contact Person Name
Vicente Estrada Pérez
Site Name
Hospital Universitario De Canarias
Department Name
Servicio de enfermedades Infecciosas
Principal Investigator Name
María Remedios Alemán Valls
Principal Investigator Email
remealeman@hotmail.com
Contact Person Name
María Remedios Alemán Valls
Contact Person Email
remealeman@hotmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Servicio de Microbiología Clínica y 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
Servico de efermedades infecciosas
Principal Investigator Name
Mar Masiá Canuto
Principal Investigator Email
marmasiac@gmail.com
Contact Person Name
Mar Masiá Canuto
Contact Person Email
marmasiac@gmail.com
Site Name
Bellvitge University Hospital
Department Name
Servicio de Infecciosas
Principal Investigator Name
María Saumoy Linares
Principal Investigator Email
msaumoy@bellvitgehospital.cat
Contact Person Name
María Saumoy Linares
Contact Person Email
msaumoy@bellvitgehospital.cat
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Servicio de enfermedades infecciosas
Principal Investigator Name
Mª Carmen Fariñas Alvarez
Principal Investigator Email
mcfarinas@humv.es
Contact Person Name
Mª Carmen Fariñas Alvarez
Contact Person Email
mcfarinas@humv.es
Site Name
Hospital Son Llatzer
Department Name
Servicio de Medicina Interna
Principal Investigator Name
Aroa Villoslada Gelabert
Principal Investigator Email
avilloslada@hsll.es
Contact Person Name
Aroa Villoslada Gelabert
Contact Person Email
avilloslada@hsll.es
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Servicio de Infecciosas
Principal Investigator Name
Maria Jose Crussels Canales
Principal Investigator Email
pcrusells@gmail.com
Contact Person Name
Maria Jose Crussels Canales
Contact Person Email
pcrusells@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Servicio de Infecciosas, Microbiología Clínica y Medicina Preventiva
Principal Investigator Name
Rosario Palacios Muñoz
Principal Investigator Email
mariar.palacios.sspa@juntadeandalucia.es
Contact Person Name
Rosario Palacios Muñoz
Site Name
Hospital Universitario La Paz
Department Name
Servicio de Medicina Interna
Principal Investigator Name
Juan González García
Principal Investigator Email
juangonzalezgar@gmail.com
Contact Person Name
Juan González García
Contact Person Email
juangonzalezgar@gmail.com

Belgium

Earliest CTIS Part Ii Submission Date
14-04-2026
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
1
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Infectious Diseases
Principal Investigator Name
Marie_angelique DeScheerder
Principal Investigator Email
marie-angelique.descheerder@uzgent.be
Contact Person Name
Marie_angelique DeScheerder
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Infectious Diseases
Principal Investigator Name
Leila Belkhir
Contact Person Name
Leila Belkhir
Site Name
Institute Of Tropical Medicine
Department Name
Infectious Diseases
Principal Investigator Name
Jelle B. Visser
Principal Investigator Email
jvisser@itg.be
Contact Person Name
Jelle B. Visser
Contact Person Email
jvisser@itg.be
Site Name
CHU Saint Pierre
Department Name
Infectious Diseases
Principal Investigator Name
Martin Vandeputte
Principal Investigator Email
martin.vandeputte@stpierre-bru.be
Contact Person Name
Martin Vandeputte

France

Earliest CTIS Part Ii Submission Date
26-03-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
33
Number Of Sites
8
Number Of Participants
10

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hotel Dieu - Service Maladies Infectieuses
Principal Investigator Name
Colin Deschanvres
Principal Investigator Email
colin.deschanvres@chu-nantes.fr
Contact Person Name
Colin Deschanvres
Site Name
Assistance Publique Hopitaux De Paris (Hopital Saint Antoine)
Department Name
Hopital Saint Antoine - Service Maladies Infectieuses et Tropicales
Principal Investigator Name
Karine Lacombe
Principal Investigator Email
karine.lacombe2@aphp.fr
Contact Person Name
Karine Lacombe
Contact Person Email
karine.lacombe2@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hopital Saint-André - Service de Médecine Interne et Maladies Infectieuses
Principal Investigator Name
Fabrice Bonnet
Principal Investigator Email
fabrice.bonnet@chu-bordeaux.fr
Contact Person Name
Fabrice Bonnet
Contact Person Email
fabrice.bonnet@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Hopital Universitaire Carémeau - 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
Assistance Publique Hopitaux De Paris (Hopital Bichat - Claude-Bernard)
Department Name
Hopital Bichat - Claude-Bernard - 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
Assistance Publique Hopitaux De Paris (Hopital Pitié-Salpêtrière)
Department Name
Hopital Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales
Principal Investigator Name
Valerie Pourcher
Principal Investigator Email
valerie.martinez@aphp.fr
Contact Person Name
Valerie Pourcher
Contact Person Email
valerie.martinez@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris (Hopital Saint Louis)
Department Name
Hopital Saint Louis - 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 Caen Normandie
Department Name
Hopital Côte de Nacre - Unité de Recherche Clinique
Principal Investigator Name
Jean-Jacques Parienti
Principal Investigator Email
parienti-jj@chu-caen.fr
Contact Person Name
Jean-Jacques Parienti
Contact Person Email
parienti-jj@chu-caen.fr

Germany

Earliest CTIS Part Ii Submission Date
13-03-2026
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
38
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
Department Name
Department of Infectious Diseases, Sankt Joseph Hospital Berlin
Principal Investigator Name
Hartmut Stocker
Principal Investigator Email
hartmut.stocker@sjk.de
Contact Person Name
Hartmut Stocker
Contact Person Email
hartmut.stocker@sjk.de
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Medizinische Klinik II Schwerpunkt Infektiologie Haus 68
Principal Investigator Name
Christoph Stephan
Principal Investigator Email
christoph.stephan@unimedizin-ffm.de
Contact Person Name
Christoph Stephan
Site Name
ICH Study Center GmbH & Co. KG
Principal Investigator Name
Christian Hoffmann
Principal Investigator Email
hoffmann@ich-hamburg.de
Contact Person Name
Christian Hoffmann
Contact Person Email
hoffmann@ich-hamburg.de
Site Name
MVZ Munchen Am Goetheplatz
Department Name
Endocrinology & Clinical Reseach
Principal Investigator Name
Sebastian Noe
Principal Investigator Email
sno@mvz-mag.de
Contact Person Name
Sebastian Noe
Contact Person Email
sno@mvz-mag.de
Site Name
Universitaetsklinikum Koeln AöR
Department Name
Innere Medizin I Infektionsambulanz
Principal Investigator Name
Clara Lehmann
Principal Investigator Email
clara.lehmann@uk-koeln.de
Contact Person Name
Clara Lehmann
Contact Person Email
clara.lehmann@uk-koeln.de

Italy

Earliest CTIS Part Ii Submission Date
27-03-2026
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
21
Number Of Sites
14
Number Of Participants
15

Sites

Site Name
National Institute For Infectious Diseases Lazzaro Spallanzani
Department Name
UOC Immunodeficienze Virali
Principal Investigator Name
Andrea Antinori
Principal Investigator Email
andrea.antinori@inmi.it
Contact Person Name
Andrea Antinori
Contact Person Email
andrea.antinori@inmi.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
UOC Malattie Infettive
Principal Investigator Name
Loredana Sarmati
Principal Investigator Email
sarmati@med.uniroma2.it
Contact Person Name
Loredana Sarmati
Contact Person Email
sarmati@med.uniroma2.it
Site Name
Azienda Ospedaliera di Padova
Department Name
UOC Malattie infettive e tropicali
Principal Investigator Name
Annamaria Cattelan
Principal Investigator Email
annamaria.cattelan@aopd.veneto.it
Contact Person Name
Annamaria Cattelan
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Promozione Salute MaternoInfantile Medicina Interna Specialistica
Principal Investigator Name
Antonio Cascio
Principal Investigator Email
antonio.cascio03@unipa.it
Contact Person Name
Antonio Cascio
Contact Person Email
antonio.cascio03@unipa.it
Site Name
ASST Fatebenefratelli Sacco
Department Name
Dipartimento di Malattie Infettive
Principal Investigator Name
Andrea Gori
Principal Investigator Email
andrea.gori@unimi.it
Contact Person Name
Andrea Gori
Contact Person Email
andrea.gori@unimi.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Malattie Infettive
Principal Investigator Name
Marco Falcone
Principal Investigator Email
marco.falcone@unipi.it
Contact Person Name
Marco Falcone
Contact Person Email
marco.falcone@unipi.it
Site Name
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Department Name
S.C. Malattie infettive e tropicali
Principal Investigator Name
Giulia Carla Marchetti
Principal Investigator Email
giulia.marchetti@unimi.it
Contact Person Name
Giulia Carla Marchetti
Contact Person Email
giulia.marchetti@unimi.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
SC Malattie Infettive
Principal Investigator Name
Diego Ripamonti
Principal Investigator Email
dripamonti@asst-pg23.it
Contact Person Name
Diego Ripamonti
Contact Person Email
dripamonti@asst-pg23.it
Site Name
Azienda Sanitaria Locale Citta Di Torino
Department Name
Clinica Malattie Infettive
Principal Investigator Name
Stefano Bonora
Principal Investigator Email
stefano.bonora@unito.it
Contact Person Name
Stefano Bonora
Contact Person Email
stefano.bonora@unito.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
S.C. Malattie Infettive
Principal Investigator Name
Emanuele Focà
Principal Investigator Email
emanuele.foca@unibs.it
Contact Person Name
Emanuele Focà
Contact Person Email
emanuele.foca@unibs.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Malattie Infettive
Principal Investigator Name
Carlo Torti
Principal Investigator Email
carlo.torti@unicatt.it
Contact Person Name
Carlo Torti
Contact Person Email
carlo.torti@unicatt.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Centro Malattie Infettive
Principal Investigator Name
Alessandra Bandera
Principal Investigator Email
alessandra.bandera@policlinico.mi.it
Contact Person Name
Alessandra Bandera
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UO Malattie Infettive
Principal Investigator Name
Antonella Castagna
Principal Investigator Email
castagna.antonella@hsr.it
Contact Person Name
Antonella Castagna
Contact Person Email
castagna.antonella@hsr.it
Site Name
IRCCS Azienda Ospedaliera Metropolitana
Department Name
U.O. Clinica di malattie infettive e tropicali
Principal Investigator Name
Antonio Di Biagio
Principal Investigator Email
antonio.dibiagio@hsanmartino.it
Contact Person Name
Antonio Di Biagio

Portugal

Earliest CTIS Part Ii Submission Date
29-01-2026
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
55
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Infectiology
Principal Investigator Name
Daniel Silva Coutinho
Principal Investigator Email
daniel.silva.coutinho@ulsge.min-saude.pt
Contact Person Name
Daniel Silva Coutinho
Site Name
Unidade Local De Saude Da Regiao De Aveiro E.P.E.
Department Name
Infectiology
Principal Investigator Name
Jorge Velez
Principal Investigator Email
jfshvelez@gmail.com
Contact Person Name
Jorge Velez
Contact Person Email
jfshvelez@gmail.com
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Infectiology
Principal Investigator Name
Josefina Mendez
Principal Investigator Email
u23231@chporto.min-saude.pt
Contact Person Name
Josefina Mendez
Contact Person Email
u23231@chporto.min-saude.pt
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Infectiology
Principal Investigator Name
Rosário Serrão
Principal Investigator Email
rosarioserrao@chsj.min-saude.pt
Contact Person Name
Rosário Serrão

Poland

Earliest CTIS Part Ii Submission Date
02-04-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
33
Number Of Sites
8
Number Of Participants
12

Sites

Site Name
Wroclawskie Centrum Zdrowia Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Department Name
Osrodek Profilaktyczno-Leczniczy Chorob Zakaznych i Terapii Uzaleznien
Principal Investigator Name
Bartosz Szetela
Principal Investigator Email
bartoszetela@gmail.com
Contact Person Name
Bartosz Szetela
Contact Person Email
bartoszetela@gmail.com
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Poradnia Nabytych Niedoborow Odpornosci
Principal Investigator Name
Monika Bociaga-Jasik
Principal Investigator Email
monika.bociagajasik@gmail.com
Contact Person Name
Monika Bociaga-Jasik
Contact Person Email
monika.bociagajasik@gmail.com
Site Name
Wojewodzki Szpital Obserwacyjno-Zakazny Im Tadeusza Browicza
Department Name
Oddzial Internistyczno-Zakazny i Niedoborow Odpornosciowych
Principal Investigator Name
Anita Olczak
Principal Investigator Email
sekretariat@wsoz.pl
Contact Person Name
Anita Olczak
Contact Person Email
sekretariat@wsoz.pl
Site Name
Centrum Medyczne W Lancucie Sp. z o.o.
Department Name
Kliniczny Oddzial Chorob Zakaznych z Pododdzialem Hepatologicznym
Principal Investigator Name
Robert Plesniak
Principal Investigator Email
robert.plesniak@wp.pl
Contact Person Name
Robert Plesniak
Contact Person Email
robert.plesniak@wp.pl
Site Name
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
Department Name
Oddzial Kliniczny Chorob Zakaznych i Hepatologii
Principal Investigator Name
Elzbieta Jablonowska
Principal Investigator Email
sekretariatf@bieganski.com.pl
Contact Person Name
Elzbieta Jablonowska
Contact Person Email
sekretariatf@bieganski.com.pl
Site Name
Samodzielny Publiczny Wojewodzki Szpital Zespolony W Szczecinie
Department Name
Oddzial Obserwacyjno-Zakazny, Chorob Tropikalnych i Nabytych Niedoborow Immunologicznych
Principal Investigator Name
Milosz Parczewski
Principal Investigator Email
milosz.parczewski@pum.edu.pl
Contact Person Name
Milosz Parczewski
Contact Person Email
milosz.parczewski@pum.edu.pl
Site Name
Szpital Specjalistyczny W Chorzowie
Department Name
Poradnia Diagnostyki i Leczenia Nabytych Niedoborow Odpornosci
Principal Investigator Name
Elzbieta Mularska
Principal Investigator Email
mulusus@yahoo.com
Contact Person Name
Elzbieta Mularska
Contact Person Email
mulusus@yahoo.com
Site Name
Punkt Zdrowia Hlebowicz Jakubowski Lekarze sp. p.
Principal Investigator Name
Maria Hlebowicz
Principal Investigator Email
kontakt@punktlekarze.pl
Contact Person Name
Maria Hlebowicz
Contact Person Email
kontakt@punktlekarze.pl

Sponsor

Primary sponsor

Full Name
Viiv Healthcare UK Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Contract research organisations

Name
IQVIA Limited
Responsibilities
sponsorDuties codes: 4
Name
Iqvia Rds Inc.
Responsibilities
eCOAs / operational support
Name
Pharmaceutical Product Development LLC
Responsibilities
sponsorDuties codes: 4
Name
Sermes CRO
Responsibilities
patient fee reimbursement

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Monogram Biosciences Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"sponsorDuties code 15; value: eCOAs","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"sponsorDuties code 15; value: eCOA data collection device","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"sponsorDuties code 15; value: patient fee reimbursement","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties code 15; value: Participant payment and travel reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Teckro Limited","duties_or_roles":"sponsorDuties code 15; value: Site engagement platform","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"sponsorDuties code 15; value: Translation Services","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"sponsorDuties code 15; value: medicine product destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties code 15; value: Clinical Trial Training (Investigator Meeting)","organisation_type":"Pharmaceutical company"}
  • {"country":"Japan","full_name":"Q2 Solutions Kk","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
VH4524184
Active Substance
VH4524184
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
Not authorised (prodAuthStatus: 1)
Dose Levels
Dose A; Dose B (two different daily oral doses - specific mg not stated in provided documents)
Frequency
daily
Investigational Product Name
Descovy 200 mg/25 mg film-coated tablets (co-administered FTC/TAF)
Active Substance
Emtricitabine; Tenofovir alafenamide
Modality
Small molecule
Routes Of Administration
ORAL
Route
oral
Authorisation Status
Authorised (marketing authorisation number: EU/1/16/1099/003; prodAuthStatus: 2)
Starting Dose
200 mg emtricitabine / 25 mg tenofovir alafenamide (as per product name)
Frequency
daily
Investigational Product Name
Dovato 50 mg/300 mg film-coated tablets (DTG/3TC FDC control arm)
Active Substance
Lamivudine; Dolutegravir sodium
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
Authorised (marketing authorisation number: EU/1/19/1370/001; prodAuthStatus: 2)
Starting Dose
50 mg dolutegravir / 300 mg lamivudine (as per product name)
Frequency
daily
Combination Treatment
Yes

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