Clinical trial • Phase II/III • Infectious Disease
GS-1720 for HIV-1 infection
Phase II/III trial of GS-1720 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
- 16-10-2024
- First CTIS Authorization Date
- 13-02-2025
Trial design
Randomised, biktarvy 50 mg/200 mg/25 mg film-coated tablets (coformulated bictegravir/emtricitabine/tenofovir alafenamide); continuing bvy is the active comparator (specific dosing schedule in this document not specified).-controlled Phase II/III trial across 33 sites in France, Germany, Italy and others.
- Randomised
- Yes
- Comparator
- Biktarvy 50 mg/200 mg/25 mg film-coated tablets (coformulated bictegravir/emtricitabine/tenofovir alafenamide); continuing BVY is the active comparator (specific dosing schedule in this document not specified).
- Target Sample Size
- 47
- Trial Duration For Participant
- 672
Eligibility
Recruits 47 No vulnerable populations selected. Participants must be 18 years of age or older and able to understand and give written informed consent; consent is provided by the participant (no assent procedures described)..
- Pregnancy Exclusion
- Positive serum pregnancy test at screening or positive pregnancy test at Day 1.
- Vulnerable Population
- No vulnerable populations selected. Participants must be 18 years of age or older and able to understand and give written informed consent; consent is provided by the participant (no assent procedures described).
Inclusion criteria
- {"criterion_text":"- Participants must meet all of the following inclusion criteria to be eligible for participation in this study: Participants 18 years of age or older and able to understand and give written informed consent.\n- Participants assigned male at birth and participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.\n- Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 24 weeks before and at screening.\n- Receiving BVY for ≥ 24 weeks prior to screening."}
Exclusion criteria
- {"criterion_text":"- Prior use of, or exposure to LEN, GS-1720, or GS-4182.\n- Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance.\n- Have been treated within 6 months of study screening or expected to receive during the study immunosuppressant therapies or chemotherapeutic agents (eg, chronic [at least 4 weeks] systemic steroids, immunoglobulins, and other immune- or cytokine-based therapies).\n- Participation in any other clinical study, including observational studies, without prior approval from the Sponsor is prohibited while participating in this study.\n- Positive serum pregnancy test at screening or positive pregnancy test at Day 1.\n- Participants with plans to breastfeed during the study period and within 60 days following the last dose of study drug.\n- Serious illness requiring hospitalizations within 30 days prior to screening and during the screening period or active malignancy requiring acute systemic treatment.\n- Known hypersensitivity to the study drug, its metabolites, or formulation excipient.\n- Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator.\n- Requirement for ongoing therapy with or prior use of any prohibited medications.\n- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements, including medical history of psychotic disorder and/or use of antipsychotic medications prescribed for psychosis.\n- History of virologic failure while on an integrase strand-transfer inhibitor (INSTI)-based regimen.\n- Documented INSTI resistance, specifically, resistance-associated mutations (RAMs) E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.\n- Prior use of any Long Acting (LA) parenteral antiretrovirals (ARVs) such as monoclonal antibodies (mAbs) or broadly neutralizing antibodies (bNAbs) targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.\n- Any of the following laboratory values at screening: a) CD4 cell count < 200 cells/mm3 at screening b) Glomerular filtration rate < 60 mL/min according to the Modification of Diet in Renal Disease formula c) Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 1.5 × upper limit of normal (ULN) d) Direct bilirubin > 1.5 × ULN e) Platelets count < 50,000 cells/mm3 f) Hemoglobin < 8.0 g/dL\n- Active tuberculosis infection.\n- Active or occult hepatitis B virus (HBV) infection as defined below (regardless of other HBV serologic results). Participants found to be susceptible to HBV infection should be recommended to receive an HBV vaccination. a) Hepatitis B surface antigen positive (HBsAg+) (or) b) Hepatitis B core antibody positive (HBcAb+) and hepatitis B surface antibody negative (HBsAb-).\n- Active hepatitis C virus (HCV) defined as detectable HCV RNA. Note: Participants with prior/inactive HCV infection (defined as undetectable HCV RNA) may enroll.\n- Moderate/severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Phase 2: The proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 as determined by the United States (US) Food and Drug Administration (FDA)-defined snapshot algorithm","definition_or_measurement_approach":"Determined by the US FDA-defined snapshot algorithm (proportion with HIV-1 RNA ≥ 50 copies/mL at Week 24)."}
- {"endpoint_text":"- Phase 3: The proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as determined by the US FDA-defined snapshot algorithm","definition_or_measurement_approach":"Determined by the US FDA-defined snapshot algorithm (proportion with HIV-1 RNA ≥ 50 copies/mL at Week 48)."}
Secondary endpoints
- {"endpoint_text":"- Phase 2: The proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Weeks 12 and 48 as determined by the US FDA-defined snapshot algorithm","definition_or_measurement_approach":"Determined by the US FDA-defined snapshot algorithm (proportion with HIV-1 RNA ≥50 copies/mL at Weeks 12 and 48)."}
- {"endpoint_text":"- Phase 2: The proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 12, 24, and 48 as determined by the US FDA-defined snapshot algorithm","definition_or_measurement_approach":"Determined by the US FDA-defined snapshot algorithm (proportion with HIV-1 RNA <50 copies/mL at Weeks 12, 24, 48)."}
- {"endpoint_text":"- Phase 2: The change from baseline in CD4+ T-cell count at Weeks 12, 24, and 48","definition_or_measurement_approach":"Change from baseline in CD4+ T-cell count measured at specified weeks (12, 24, 48)."}
- {"endpoint_text":"- Phase 2: The proportion of participants experiencing treatment-emergent adverse events (TEAEs), and treatment-emergent laboratory abnormalities through Weeks 12, 24, and 48","definition_or_measurement_approach":"Incidence of TEAEs and treatment-emergent laboratory abnormalities up to Weeks 12, 24, and 48 (as captured in safety assessments)."}
- {"endpoint_text":"- Phase 2: PK parameters (Cmax, Tmax, Ctau, and AUCtau, as applicable) of GS-1720 and lenacapavir (LEN)","definition_or_measurement_approach":"Pharmacokinetic parameters including Cmax, Tmax, Ctau, and AUCtau for GS-1720 and lenacapavir as applicable."}
- {"endpoint_text":"- Phase 3: The proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 as determined by the US FDA-defined snapshot algorithm","definition_or_measurement_approach":"Determined by the US FDA-defined snapshot algorithm (proportion with HIV-1 RNA ≥50 copies/mL at Week 96)."}
- {"endpoint_text":"- Phase 3: The proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 as determined by the US FDA-defined snapshot algorithm","definition_or_measurement_approach":"Determined by the US FDA-defined snapshot algorithm (proportion with HIV-1 RNA <50 copies/mL at Weeks 48 and 96)."}
- {"endpoint_text":"- Phase 3: The change from baseline in CD4+ T-cell count at Weeks 48 and 96","definition_or_measurement_approach":"Change from baseline in CD4+ T-cell count measured at Weeks 48 and 96."}
- {"endpoint_text":"- Phase 3: The proportion of participants experiencing TEAEs, and treatment-emergent laboratory abnormalities through Weeks 48 and 96","definition_or_measurement_approach":"Incidence of TEAEs and treatment-emergent laboratory abnormalities up to Weeks 48 and 96 (safety assessments)."}
Recruitment
- Planned Sample Size
- 47
- Recruitment Window Months
- 57
- Consent Approach
- Participants must be 18 years of age or older and able to understand and give written informed consent. Subject information and informed consent forms (ICFs) and related patient-facing documents are provided in multiple languages (English, French, German, Italian, Spanish, Swedish, Polish). Specific ICF variants include main ICFs and pregnancy-related ICFs; consent is provided by the participant (no pediatric assent described).
Geography
- Total Number Of Sites
- 33
- Total Number Of Participants
- 35
France
- Earliest CTIS Part Ii Submission Date
- 21-01-2025
- Latest Decision Or Authorization Date
- 13-02-2025
- Processing Time Days
- 23
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- Site Name
- Hopital Europeen Marseille
- Department Name
- Service Interne et Maladies Infectieuses
- Principal Investigator Name
- Patrick PHILIBERT
- Principal Investigator Email
- p.philibert@hopital-europeen.fr
- Contact Person Name
- Patrick PHILIBERT
- Contact Person Email
- p.philibert@hopital-europeen.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Didier NEAU
- Principal Investigator Email
- Didier.neau@chu-bordeaux.fr
- Contact Person Name
- Didier NEAU
- Contact Person Email
- Didier.neau@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Department of Infectious and Tropical Diseases
- 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
- Centre Hospitalier Universitaire D Orleans
- Department Name
- Infectious and Tropical Diseases Department
- Principal Investigator Name
- Laurent HOCQUELOUX
- Principal Investigator Email
- Laurent.hocqueloux@chu-orleans.fr
- Contact Person Name
- Laurent HOCQUELOUX
- Contact Person Email
- Laurent.hocqueloux@chu-orleans.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 24-01-2025
- Latest Decision Or Authorization Date
- 18-02-2025
- Processing Time Days
- 25
- Number Of Sites
- 8
- Number Of Participants
- 8
Sites
- Site Name
- Dr. Scholten und Schneeweiß GbR
- Principal Investigator Name
- Stefan Scholten
- Principal Investigator Email
- stefan.scholten@praxis-hohenstaufenring.de
- Contact Person Name
- Stefan Scholten
- Contact Person Email
- stefan.scholten@praxis-hohenstaufenring.de
- Site Name
- zibp Zentrum fuer Infektiologie Berlin Prenzlauer Berg GmbH
- Principal Investigator Name
- Stephan Grunwald
- Principal Investigator Email
- grunwald@zfi-berlin.de
- Contact Person Name
- Stephan Grunwald
- Contact Person Email
- grunwald@zfi-berlin.de
- Site Name
- ICH Study Center GmbH & Co. KG
- Principal Investigator Name
- Christian Hoffmann
- Principal Investigator Email
- hoffmann@ich-studycenter.com
- Contact Person Name
- Christian Hoffmann
- Contact Person Email
- hoffmann@ich-studycenter.com
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Rheumatologie und Immunologie Gebäude K14
- Principal Investigator Name
- Georg Behrens
- Principal Investigator Email
- behrens.georg@mh-hannover.de
- Contact Person Name
- Georg Behrens
- Contact Person Email
- behrens.georg@mh-hannover.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Dermatologie, Venerologie und Allergologie, HPSTD-Ambulanz
- Principal Investigator Name
- Stefan Esser
- Principal Investigator Email
- stefan.esser@uk-essen.de
- Contact Person Name
- Stefan Esser
- Contact Person Email
- stefan.esser@uk-essen.de
- Site Name
- Mannheimer Onkologie Praxis
- Principal Investigator Name
- Roger Vogelmann
- Principal Investigator Email
- vogelmann@mannheimer-onkologie-praxis.de
- Contact Person Name
- Roger Vogelmann
- Contact Person Email
- vogelmann@mannheimer-onkologie-praxis.de
- Site Name
- Medical Center - University Of Freiburg
- Principal Investigator Name
- Matthias Müller
- Principal Investigator Email
- med.infektiologie.studien@uniklinik-freiburg.de
- Contact Person Name
- Matthias Müller
- Contact Person Email
- med.infektiologie.studien@uniklinik-freiburg.de
- Site Name
- Walk In Ruhr Zentrum Fuer Sexuelle Gesundheit Und Medizin
- Principal Investigator Name
- Anja Potthoff
- Principal Investigator Email
- Anja.potthoff@klinikum-bochum.de
- Contact Person Name
- Anja Potthoff
- Contact Person Email
- Anja.potthoff@klinikum-bochum.de
Italy
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 18-02-2025
- Processing Time Days
- 111
- Number Of Sites
- 7
- Number Of Participants
- 7
Sites
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- SC Malattie Infettive I
- Principal Investigator Name
- Roberto Gulminetti
- Principal Investigator Email
- r.gulminetti@smatteo.pv.it
- Contact Person Name
- Roberto Gulminetti
- Contact Person Email
- r.gulminetti@smatteo.pv.it
- 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
- IRCCS Ospedale Policlinico San Martino
- Department Name
- U.O. CIinica di Malattie lnfettive e Tropicali
- Principal Investigator Name
- Antonio Biagio
- Principal Investigator Email
- antonio.dibiagio@hsanmartino.it
- Contact Person Name
- Antonio Biagio
- Contact Person Email
- antonio.dibiagio@hsanmartino.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Infectious diseases Unit
- 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
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Malattie Infettive
- Principal Investigator Name
- Carlo Torti
- Principal Investigator Email
- carlo.torti@policlinicogemelli.it
- Contact Person Name
- Carlo Torti
- Contact Person Email
- carlo.torti@policlinicogemelli.it
- Site Name
- ASST Fatebenefratelli Sacco
- Department Name
- Malattie Infettive 2
- 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 Sanitaria Locale Citta Di Torino
- Department Name
- Clinica Universitaria 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
Spain
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 17-02-2025
- Processing Time Days
- 110
- Number Of Sites
- 5
- Number Of Participants
- 5
Sites
- Site Name
- University Hospital Son Espases
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Francisco Javier Fanjul Losa
- Principal Investigator Email
- franciscoj.fanjul@ssib.es
- Contact Person Name
- Francisco Javier Fanjul Losa
- Contact Person Email
- franciscoj.fanjul@ssib.es
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Antonio Rivero Román
- Principal Investigator Email
- ariveror@gmail.com
- Contact Person Name
- Antonio Rivero Román
- Contact Person Email
- ariveror@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Jose Luis Casado Osorio
- Principal Investigator Email
- jose.casado@salud.madrid.org
- Contact Person Name
- Jose Luis Casado Osorio
- Contact Person Email
- jose.casado@salud.madrid.org
- Site Name
- Hospital Del Mar
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Robert Güerri Fernández
- Principal Investigator Email
- rguerri@psmar.cat
- Contact Person Name
- Robert Güerri Fernández
- Contact Person Email
- rguerri@psmar.cat
- Site Name
- Bellvitge University Hospital
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Arkaitz Imaz Vacas
- Principal Investigator Email
- aimaz@bellvitgehospital.cat
- Contact Person Name
- Arkaitz Imaz Vacas
- Contact Person Email
- aimaz@bellvitgehospital.cat
Sweden
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 17-02-2025
- Processing Time Days
- 110
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Soedersjukhuset AB
- Department Name
- Venhälsan/infektionsmottagningen, Sjukhusbacken 10, 118 83 Stockholm
- Principal Investigator Name
- Carl Johan Treutiger
- Principal Investigator Email
- carl-johan.treutiger@regionstockholm.se
- Contact Person Name
- Carl Johan Treutiger
- Contact Person Email
- carl-johan.treutiger@regionstockholm.se
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Infektion, Journalvägen 10, 416 50 Göteborg
- Principal Investigator Name
- Aylin Yilmaz
- Principal Investigator Email
- aylin.yilmaz@infect.gu.se
- Contact Person Name
- Aylin Yilmaz
- Contact Person Email
- aylin.yilmaz@infect.gu.se
- Site Name
- Karolinska University Hospital
- Department Name
- ME, Infektionskliniken, I 73, 141 86 Stockholm
- Principal Investigator Name
- Piotr Nowak
- Principal Investigator Email
- piotr.nowak@regionstockholm.se
- Contact Person Name
- Piotr Nowak
- Contact Person Email
- piotr.nowak@regionstockholm.se
Poland
- Earliest CTIS Part Ii Submission Date
- 17-01-2025
- Latest Decision Or Authorization Date
- 24-02-2025
- Processing Time Days
- 38
- Number Of Sites
- 6
- Number Of Participants
- 8
Sites
- Site Name
- Samodzielny Publiczny Wojewodzki Szpital Zespolony W Szczecinie
- Principal Investigator Name
- Miłosz Parczewski
- Principal Investigator Email
- Milosz.parczewski@pum.edu.pl
- Contact Person Name
- Miłosz Parczewski
- Contact Person Email
- Milosz.parczewski@pum.edu.pl
- Site Name
- Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
- Principal Investigator Name
- Elżbieta Jabłonowska
- Principal Investigator Email
- elzbieta.jablonowska@umed.lodz.pl
- Contact Person Name
- Elżbieta Jabłonowska
- Contact Person Email
- elzbieta.jablonowska@umed.lodz.pl
- Site Name
- Punkt Zdrowia Hlebowicz Jakubowski Lekarze sp. p.
- Principal Investigator Name
- Maria Hlebowicz
- Principal Investigator Email
- m.hlebowicz@punktlekarze.pl
- Contact Person Name
- Maria Hlebowicz
- Contact Person Email
- m.hlebowicz@punktlekarze.pl
- Site Name
- Wojewodzki Szpital Obserwacyjno-Zakazny Im Tadeusza Browicza
- Principal Investigator Name
- Anita Olczak
- Principal Investigator Email
- anita_olczak@interia.pl
- Contact Person Name
- Anita Olczak
- Contact Person Email
- anita_olczak@interia.pl
- Site Name
- Wojewodzki Szpital Zakazny W Warszawie SPZOZ
- Principal Investigator Name
- Alicja Wiercińska- Drapało
- Principal Investigator Email
- awiercinska@zakazny.pl
- Contact Person Name
- Alicja Wiercińska- Drapało
- Contact Person Email
- awiercinska@zakazny.pl
- Site Name
- SP ZOZ Szpital Uniwersytecki w Krakowie Poradnia Nabytych Niedoborów Odporności
- Principal Investigator Name
- Monika Bociąga-Jasik
- Principal Investigator Email
- monika.bociagajasik@gmail.com
- Contact Person Name
- Monika Bociąga-Jasik
- Contact Person Email
- monika.bociagajasik@gmail.com
Sponsor
Primary sponsor
- Full Name
- Gilead Sciences Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- Central Lab
- Name
- PPD Development LP
- Responsibilities
- Site Management
Third parties
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Lab","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Site Management","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- GS-1720
- Active Substance
- GS-1720
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- oral
- Starting Dose
- 325 mg (GS-1720 325 mg tablet)
- Frequency
- weekly
- Maximum Dose
- maxDailyDoseAmount: 650 mg; maxTotalDoseAmount: 1300 mg
- Investigational Product Name
- GS-4182
- Active Substance
- GS-4182
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- oral
- Starting Dose
- 300 mg (GS-4182 300 mg tablet)
- Frequency
- weekly
- Maximum Dose
- maxDailyDoseAmount: 300 mg; maxTotalDoseAmount: 600 mg
- Investigational Product Name
- Biktarvy 50 mg/200 mg/25 mg film-coated tablets
- Active Substance
- Bictegravir; Emtricitabine; Tenofovir alafenamide
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- oral
- Authorisation Status
- Marketing authorisation EU/1/18/1289/001 (authorisationCountryCode: EU)
- Starting Dose
- 50 mg/200 mg/25 mg (per film-coated tablet)
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.