| Selzentry (maraviroc) / ViiV Healthcare |
ACTRN12611000816954: A randomised, open-label study to evaluate the efficacy and safety of maraviroc (MVC) as a switch for either nucleoside or nucleotide analogue reverse transcriptase inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV-1 infected individuals with stable, well-controlled plasma HIV-RNA while taking their first N(t)RTI + PI/r regimen of combination antiretroviral therapy (cART): MARCH study |
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| Recruiting | 4 | 560 | | | University of New South Wales, Kirby Institute, Pfizer Inc., a Delaware Corporation | HIV | | | | |
2010-023625-38: Trial to investigating the effect of Maraviroc on movement of microbes across the gut wall in HIV-1 infected individuals who are receiving antiretroviral therapy |
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| Ongoing | 4 | 10 | Europe | Film-coated tablet, Celsentri film-coated tablets | Guy's and St Thomas' NHS Foundation Trust, ViiV Healthcare UK Ltd. | HIV, HIV, Diseases [C] - Immune System Diseases [C20] | | | | |
2013-004809-24: The role of Home packs of HIV PEPSE in High Risk Individuals |
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| Ongoing | 4 | 140 | Europe | Film-coated tablet, Celsentri (Trial Arm A), Truvada (Trial Arm A), Celsentri (Trial Arm B), Truvada (Trial Arm B) | Guy's & St. Thomas' NHS Foundation Trust, Viiv Healthcare UK Ltd, Gilead Sciences Ltd | HIV, HIV, Diseases [C] - Virus Diseases [C02] | | | | |
2014-002134-31: Maraviroc and cardiovascular risk in HIV+ patients. Maraviroc e rischio cardiovascolare in pazienti HIV+. |
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| Ongoing | 4 | 40 | Europe | NA, NA, Film-coated tablet, Celsentri | Ospedale L. Sacco - Azienda Ospedaliera-Polo Universitario, Ospedale L. Sacco - Azienda Ospedaliera-Polo Universitario | HIV-1 infection. Infezione da HIV-1., HIV-1 HIV-1, Diseases [C] - Virus Diseases [C02] | | | | |
2008-002978-35: Intensification of HAART with Maraviroc (MVC) as first line therapy of HIV-1-infected patients to rapidly suppress viral replication and minimize the evolution of drug-resistant variants |
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| Ongoing | 4 | 20 | Europe | MARAVIROC, | AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE) | First line therapy of HIV-1-infected patients. | | | | |
2008-003635-20: Maraviroc Immune Recovery Study (MIRS):A multicentre, randomized, placebo-controlled, exploratory mechanistic study into the role of Maraviroc on immune recovery |
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| Ongoing | 4 | 130 | Europe | Celsentry, Celsentry | Universitair Medisch Centrum Utrecht | HIV-1 infection | | | | |
2008-006286-80: Evaluación de los niveles farmacológicos de Maraviroc en Líquido Cefalorraquídeo (LCR) y semen en sujetos infectados por el VIH. |
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| Ongoing | 4 | 12 | Europe | Celsentri, Celsentri | Daniel Podzamczer Palter | Infección por VIH | | | | |
2009-014694-40: A pilot evaluation of the pharmacokinetics, efficacy and safety of switching from efavirenz to maraviroc administered at 600mg then 300mg twice-daily in patients suppressed on an efavirenz-containing regimen as initial therapy |
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| Ongoing | 4 | 12 | Europe | | | HIV | | | | |
2010-022202-41: ESTUDIO PILOTO DEL CAMBIO EN LA ACTIVIDADANTIRRETROVIRAL EN SISTEMA NERVIOSO CENTRAL TRAS LA SUSTITUCIÓN DE TDF/FTC/EFV POR ABC/3TC/MVC |
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| Ongoing | 4 | 15 | Europe | CELSENTRI 150 mg comprimidos recubiertos con película, ATRIPLA 600 mg/245 mg comprimidos recubiertos con película, KIVEXA 600 mg/300 mg comprimidos recubiertos con película, CELSENTRI 150 mg comprimidos recubiertos con película, ATRIPLA 600 mg/245 mg comprimidos recubiertos con película, KIVEXA 600 mg/300 mg comprimidos recubiertos con película | Daniel Podzamczer | Virus de imunodeficiencia humana-1 | | | | |
2010-023192-26: EFFECT OF SWITCHING FROM NRTIS TO MARAVIROC ON NRTI-ASSOCIATED MITCHONDRIAL TOXICITY AND IMMUNE ACTIVATION Auswirkung des Wechsels von NRTIs zu Maraviroc auf NRTI-assoziierte mitochondriale Toxizität und Immunaktivierung |
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| Ongoing | 4 | 80 | Europe | Celcentri, Celcentri, Celcentri | mib Dienstleistungsgesellschaft mbH, ViiV Healthcare GmbH | Increases in inflammatory biomarkers have been associated with various non-AIDS complications such as cardiovascular events. Maraviroc has no known toxic effects on mitochondria and has been shown to reduce immune activation / inflammation in treatment intensification settings. The purpose of this study is to investigate if switching from NRTIs to Maraviroc results in reversal of NRTI-associated mitochondrial toxicity and decreases in markers of immune activation and inflammation. | | | | |
2011-003447-21: Randomised controlled trial of the tolerability and completion of maraviroc compared to Kaletra© in combination with Truvada© for HIV post-exposure prophylaxis |
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| Ongoing | 4 | 280 | Europe | Maraviroc, Celsentri, Celsentri | Camden Provider Services, Pfizer | Prophylaxis and prevention of HIV Infection. | | | | |
2012-000649-11: SSAT046 Addition of Maraviroc to monotherapy Darunavir/Ritonavir study |
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| Ongoing | 4 | 30 | Europe | Darunavir, Ritonavir, Maraviroc, Prezista, Norvir, Celsentri, Prezista, Norvir, Celsentri | St Stephen\'s Aids Trust, St Stephen\'s AIDS Trust, Pfizer Inc | HIV | | | | |
2012-003778-16: The dose and genital tract concentration of Maraviroc needed for protection from HIV infection |
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| Ongoing | 4 | 54 | Europe | Celsentri, Celsentri | Guy\'s & St. Thomas\' NHS Foundation Trust, Pfizer Inc | HIV | | | | |
| Not yet recruiting | 4 | 186 | NA | Placebo for MVC, Maraviroc, MVC, Placebo for DTG, Dolutegravir, DTG | AIDS Clinical Trials Group, National Institute of Allergy and Infectious Diseases (NIAID) | HIV-1 Infection | 06/17 | 06/18 | | |
2017-004141-24: A study in which people who have HIV and fatty liver disease, who do not drink excessive alcohol, are either asked to take the drug maraviroc on top of their normal anti-HIV medicines or to take their normal anti-HIV medicines alone |
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| Ongoing | 4 | 60 | Europe | Celsentri, Film-coated tablet, Celsentri | Brighton and Sussex University Hospitals NHS Trus | Non-alcoholic fatty liver disease in people living with well-controlled HIV-1 infection, A disease of too much fat laid down in the liver in people who have HIV and do not drink over the recommended limit of alcohol, Diseases [C] - Digestive System Diseases [C06] | | | | |
2017-004750-42: EFFICACY AND SAFETY OF A SIMPLIFICATION TREATMENT BASED ON DOLUTEGRAVIR AND DARUNAVIR / COBICISTAT VS USUAL TREATMENT IN SUPPRESSED HIV-1-INFECTED PATIENTS WITH MULTIDRUG RESISTANCE. Eficacia y seguridad de Dolutegravir más Darunavir/cobicistat como tratamiento de simplificación frente al tratamiento habitual en pacientes infectados por el VIH-1 virológicamente suprimidos y con resistencia a múltiples fármacos. |
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| Ongoing | 4 | 100 | Europe | lamivudine, Efavirenz, Nevirapine, Film-coated tablet, Coated tablet, Capsule, hard, Tablet, Rezolsta, Tivicay, Ziagen, EMTRIVA, VIREAD, kivexa, Truvada, Intelence, Edurant, Atripla, Eviplera, Reyataz, Prezista, Kaletra, Norvir, Evotaz, Isentress, Stribild, Triumeq, Genvoya, Celsentri, Descovy | FUNDACIÓ LLUITA CONTRA LA SIDA, ViiV Healthcare | HIV-1 VIH-1, HIV infection Infección por VIH, Diseases [C] - Virus Diseases [C02] | | | | |
| Ongoing | 3 | 120 | Europe | CELSENTRI, REYATAZ, NORVIR, TRUVADA, CELSENTRI, REYATAZ, NORVIR, TRUVADA | AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA | HIV/ HCV Coinfection | | | | |
2010-019518-25: (Maraviroc ENHancement of Immunological Response): A pilot study of maraviroc as an add-on in patients with reduced CD4 cell count despite full viral suppression |
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| Ongoing | 3 | 20 | Europe | Tablet | AZIENDA OSPEDALIERA \"OSPEDALI RIUNITI DI BERGAMO\" (A.O. DI RILIEVO NAZIONALE) | HIV | | | | |
2011-004435-31: An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc. |
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| Ongoing | 3 | 12 | Europe | CELSENTRI 300mg Film coated tablets, CELSENTRI 300mg Film coated tablets | ViiV Healthcare UK Limited, VIIV HEALTHCARE UK LIMITED, ViiV Healthcare | HIV-1 infection | | | | |
2016-003741-29: Study of the use of anti_HIV drugs with reduced neuronal toxicity (including maraviroc) in patients with neurocogntive disorders Utilizzo di farmaci per il trattamento dell'infezione da HIV a ridotta tossicit¿ sui neuroni (incluso maraviroc) in pazienti con disturbi neurocognitivi |
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| Not yet recruiting | 3 | 76 | Europe | CELSENTRI, EMTRIVA, MARAVIROC, EMTRIVA, Coated tablet, CELSENTRI - 300 MG COMPRESSA RIVESTITA CON FILM - USO ORALE BLISTER (PVC/ALU) 60 COMPRESSE, REZOLSTA - 800 MG/ 150 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE-FLACONE (HDPE)- 30 COMPRESSE, EMTRIVA - 30 CAPSULE RIGIDE IN FLACONE DA 200 MG | A.S.L. TO 2, Viiv Healthcare | HIV-infection, HIV-associated neurocognitive disorders Infezione da HIV, disordini neurocognitivi HIV-correlati, HIV-infection with neurocognitive problems Infezione da HIV con problemi neurocognitivi, Diseases [C] - Virus Diseases [C02] | | | | |
| Withdrawn | 3 | 14 | Europe | maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD), CELSENTRI, REYATAZ, NORVIR | University of Turin, Italy, Alfred Health
| Heart failure | 12/17 | 12/17 | | |
NCT00791700 / 2008-006873-33: An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children |
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| Active, not recruiting | 2 | 103 | Europe, US, RoW | Maraviroc, Selzentry | ViiV Healthcare, Pfizer | Human Immunodeficiency Virus | 04/15 | 06/23 | | |
2008-006287-11: Virologic efficacy of Maraviroc in adult naive HIV patients with HIV-RNA>= 1000 copies/ml |
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| Ongoing | 2 | 60 | Europe | CELSENTRI, TRUVADA, KALETRA, CELSENTRI, TRUVADA, KALETRA | OSPEDALE S. RAFFAELE | naive HIV affected patients | | | | |
2009-016480-11: “No Nuc, No Boost” : A phase 2 pilot study of simplification by Maraviroc-Raltegravir following 6 months of treatment with Maraviroc-Raltegravir-Tenofovir-Emtricitabine in naive patients infected by CCR5 HIV-1 |
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| Ongoing | 2 | 40 | Europe | Raltegravir, Maraviroc, Tenofovir/Emtricitabine, ISENTRESS, CELSENTRI, TRUVADA, ISENTRESS, CELSENTRI, TRUVADA | P Pierre Dellamonica | HIV naïve patients, CCR5 tropism, with CD4 > 200/mm3 and HIV RNA < 100 000 copy/ml. | | | | |
2009-014406-34: International, multicenter, randomized, non-comparative controlled study of therapeutic intensification plus immunomodulation in HIV patients with long-term viral suppression |
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| Ongoing | 2 | 12 | Europe | GLYCOSYLATED RECOMBINANT HUMAN INTERLEUKIN-7, MARAVIROC, RALTEGRAVIR, CYT107, SELZENTRY, CELSENTRI, ISENTRESS, SELZENTRY, CELSENTRI, ISENTRESS | ORVACS, KEYRUS BIOPHARMA, , Bettencourt-Schueller Foundation | HIV-1 Infection | | | | |
2016-003575-21: MAVMET: A research study exploring whether MAraViroc, a licensed treatment for HIV infection and METformin, a licensed treatment for diabetes, are effective and safe at reducing the amount of fat in the liver. |
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| Ongoing | 2 | 88 | Europe | Metformin, Celsentri, metformin, metformin, maraviroc, Film-coated tablet, Metformin, Celsentri, metformin | MRC Clinical Trials Unit at UCL, Viiv Healthcare | Hepatic steatosis in adults with chronic HIV-1 infection, HIV-1- infected patients with non-alcoholic fatty liver disease, Diseases [C] - Nutritional and Metabolic Diseases [C18] | | | | |
| Ongoing | 2 | 30 | Europe | Celsentri, Film-coated tablet, Celsentri | Imperial College London | Non alcoholic steatohepatitis (NASH) in patients with HIV mono-infection., Fatty liver disease in patients with HIV infection., Diseases [C] - Digestive System Diseases [C06] | | | | |
| Completed | 2 | 10 | RoW | Maraviroc 300 mg | Tel-Aviv Sourasky Medical Center | Post-stroke Depression | 08/22 | 08/22 | | |
NCT04966429: Safety and Efficacy of Maraviroc in Post-stroke Cognitive Impairment |
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| Recruiting | 2 | 150 | RoW | Maraviroc | Tel-Aviv Sourasky Medical Center, Hadassah Medical Center, Soroka University Medical Center | Post Stroke Cognitive Impairment | 04/24 | 06/24 | | |
| Recruiting | 2 | 90 | US | tenofovir disoproxil/emtricitabine, TDF/FTC, Truvada, Selzentry, Placebo | Icahn School of Medicine at Mount Sinai, Yale University, PolyBio Research Foundation | Long Covid | 01/26 | 01/26 | | |
CAMAROS, NCT04789616: The Canadian Maraviroc Randomized Controlled Trial To Augment Rehabilitation Outcomes After Stroke |
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| Recruiting | 2 | 120 | Canada | Maraviroc, Celsentri, Exercise Program, Placebo, "Sugar" Pill, Activity Sensor, Motor Learning | University of Calgary, University Health Network, Toronto, University of California, Los Angeles, Sunnybrook Health Sciences Centre, University of British Columbia, Memorial University of Newfoundland, Dalhousie University, Parkwood Hospital, London, Ontario, Riverview Health Centre Foundation, The Dr. Miriam and Sheldon G. Adelson Medical Research Foundation | Stroke | 12/25 | 12/25 | | |
NCT05470491: Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ... |
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| Recruiting | 1/2 | 265 | US | RIC, GVHD prophylaxis, allo HCT, Plerixafor, Maraviroc | National Cancer Institute (NCI) | HIV, Hematologic Malignancies | 07/26 | 07/27 | | |
ChiCTR-OIC-17013778: Phase I trial of PD-1 combination with CCR5 inhibition for the treatment of metastatic gastric cancer |
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| Not yet recruiting | 1 | 20 | China | Pembrolizumab plus Maraviroc | Shanghai Tenth Peoples' Hospital ; Shanghai Tenth Peoples' Hospital, Shanghai Science and Technology Committee | Gastric Cancer | | | | |
NCT04721301: Ipilimumab, Maraviroc and Nivolumab in Advanced Metastatic Colorectal and Pancreatic Cancer the LUMINESCENCE Trial |
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| Completed | 1 | 50 | Europe | Nivolumab plus Ipilimumab plus Maraviroc | University Hospital Heidelberg, German Cancer Research Center | Colorectal Cancer Metastatic, Pancreatic Cancer Metastatic | 03/23 | 03/23 | | |
NCT00801515: A Compassionate Access Protocol For Those Patients Who Have Completed A4001029 |
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| No Longer Available | N/A | | Canada | Maraviroc, Celsentri | ViiV Healthcare, Pfizer | HIV | 07/11 | 07/11 | | |
NCT01776996: An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc |
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| No Longer Available | N/A | | Europe, RoW | Continued Access Arm | ViiV Healthcare, GlaxoSmithKline | Infection, Human Immunodeficiency Virus | | | | |
NCT00992654: A Treatment Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India |
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| No Longer Available | N/A | | NA | Open Label Treatment Access: Maraviroc, Maraviroc, Celsentri, Selzentry | ViiV Healthcare, Pfizer | Human Immunodeficiency Virus (HIV) | | | | |
NCT06805656: Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming the Sustained HIV Remission Without Antiretrovirals |
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| Not yet recruiting | N/A | 70 | RoW | Maraviroc, Selzentry, Celsentri, Dolutegravir, Tivicay, Dendritic Cell Vaccine, DC Vaccine, Auranofin, Gold Salt, Sirtuin Histone deacetylase inhibitor, Nicotinamide | Federal University of São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico | Hiv, HIV I Infection | 07/26 | 12/27 | | |
| Vyrologix (leronlimab) / CytoDyn, Vyera Pharma, amfAR |
2020-001996-33: A Phase 2b/3 Study to Evaluate the Efficacy and Safety of Leronlimab for Patients with Severe or Critical Coronavirus Disease 2019 (COVID-19) |
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| Not yet recruiting | 3 | 290 | Europe | Leronlimab(PRO 140), Injection, Leronlimab Injection 175mg/ml (PRO-140) | CytoDyn, Inc., CytoDyn, Inc. | Coronavirus Disease 2019 (COVID-19), Coronavirus Disease, Diseases [C] - Virus Diseases [C02] | | | | |
NCT02990858: An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study |
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| Active, not recruiting | 2/3 | 44 | NA | PRO 140 SC injections | CytoDyn, Inc. | Hiv, Human Immunodeficiency Virus | 06/22 | 08/22 | | |
NCT03902522: PRO 140 in Treatment-Experienced HIV-1 Subjects |
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| Active, not recruiting | 2/3 | 25 | US | PRO 140, Leronlimab | CytoDyn, Inc. | HIV-1-infection | 07/22 | 08/22 | | |
| Active, not recruiting | 2/3 | 56 | US | PRO 140 350, PRO 140 525, PRO 140 700 | CytoDyn, Inc. | HIV-1-infection | 12/22 | 04/23 | | |
NCT02859961: Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection |
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| Active, not recruiting | 2b | 556 | US | PRO 140 (350 mg), Leronlimab, PRO 140 (525 mg), PRO 140 (700 mg) | CytoDyn, Inc. | HIV | 09/20 | 06/22 | | |
NCT04347239 / 2020-001996-33: Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19) |
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| Active, not recruiting | 2b | 394 | US | Placebos, Leronlimab (700mg) | CytoDyn, Inc., CytoDyn, Inc. | Coronavirus Disease 2019 | 10/21 | 06/22 | | |
NCT04504942: Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors |
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| Active, not recruiting | 2 | 30 | US | Leronlimab | CytoDyn, Inc., Amarex Clinical Research | Solid Tumor, Adult | 11/21 | 07/22 | | |
NCT04521114: Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis |
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| Completed | 2 | 87 | US | Placebo, leronlimab 700 mg, PRO 140, leronlimab 350 mg | CytoDyn, Inc., Amarex Clinical Research | Nonalcoholic Steatohepatitis (NASH) | 12/21 | 12/21 | | |
| Active, not recruiting | 2 | 28 | US | PRO 140 350mg weekly SQ injection., PRO 140 | CytoDyn, Inc. | HIV, Human Immunodeficiency Virus | 06/22 | 08/22 | | |
NCT05730673: Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer |
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| Withdrawn | 2 | | NA | 700mg leronlimab weekly dose, 80mg Regorafenib at week 1, 120mg Regorafenib at week2, 160 mg Regorafenib at week 3 | CytoDyn, Inc., Amarex Clinical Research | CCR5, Microsatellite Stable, Metastatic, Colorectal Cancer | 05/23 | 08/23 | | |
NCT06699836: A Phase 2 Study of Leronlimab in Combination with TAS-102 + Bevacizumab in Previously Treated Participants with MCRC |
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| Not yet recruiting | 2 | 60 | NA | 350 mg leronlimab, PRO 140, 700 mg leronlimab | CytoDyn, Inc., Syneos Health | Metastatic Colorectal Cancer (mCRC) | 06/28 | 08/28 | | |
NCT03838367: Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ mTNBC |
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| Active, not recruiting | 1/2 | 48 | US | 350 mg leronlimab, PRO 140, 525 mg leronlimab, 700 mg leronlimab, AUC 5 Carboplatin, Maximum Tolerated Dose (MTD) of leronlimab | CytoDyn, Inc., Amarex Clinical Research | Triple Negative Breast Neoplasms | 07/22 | 09/22 | | |
CD02_EA, NCT02759042: An Expanded Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PR0140_CD02 Study |
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| No Longer Available | N/A | | US | PRO 140, PRO140, CCR5 antagonist, Humanized monoclonal antibody to CCR5 | CytoDyn, Inc., Amarex Clinical Research | HIV | | | | |
NCT04313075: A Compassionate Use Study of Leronlimab in Breast Cancer |
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| No Longer Available | N/A | | NA | Leronlimab, (PRO 140) | CytoDyn, Inc. | Metastatic Triple-Negative Breast Carcinoma | | | | |
| Fludase (oplunofusp) / Ansun Biopharma |
NCT03808922 / 2018-004318-16: Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study |
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| Recruiting | 3 | 274 | Europe, US, RoW | DAS181, Placebo, DAS181 COVID-19, DAS181 OL | Ansun Biopharma, Inc. | Lower Respiratory Tract Infection, Parainfluenza, Immunocompromised, COVID-19 | 08/25 | 08/25 | | |
| Not yet recruiting | 2b | 280 | RoW | DAS181, Placebo | Ansun Biopharma, Inc. | Influenza Infection, SAD-RV Infection and COVID-19 | 03/21 | 09/22 | | |
NCT04460547: Worldwide Trends on COVID-19 Research After the Declaration of COVID-19 Pandemic |
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| Not yet recruiting | N/A | 200 | NA | Convalescent Plasma Transfusion, Hydroxychloroquine, DAS181, Ivermectin, Interferon Beta-1A | Qassim University | COVID-19 | 08/20 | 09/20 | | |
| Trogarzo (ibalizumab IV) / Theratechnologies, TaiMed Biologics |
NCT03913195: Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection |
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| Completed | 3 | 46 | US | ibalizumab-uiyk, Trogarzo | TaiMed Biologics Inc., Westat | HIV-1-infection | 10/22 | 10/22 | | |
NCT05890963: 10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults |
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| Recruiting | 1 | 20 | RoW | ART, antiretroviral therapy, 10E8.4/iMab, ibalizumab, VRC07-523LS, VRC01 variant | David Ho, Henry M. Jackson Foundation for the Advancement of Military Medicine, US Military HIV Research Program, National Institute of Allergy and infectious Diseases (NIAID)/Vaccine Research Center (VRC) | HIV-1-infection | 05/25 | 02/26 | | |
NCT02028819: Compassionate Use of Ibalizumab for the Treatment of HIV Infection |
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| No Longer Available | N/A | | US | Dolutegravir Sodium Monohydrate, TIVICAY, Ibalizumab, TMB-355 | University of Colorado, Denver | Human Immunodeficiency Virus (HIV) | 02/14 | 02/14 | | |
NCT05495204: External Comparison of Ibalizumab in Trials vs. Other Regimens in OPERA |
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| Completed | N/A | 141 | US | Ibalizumab, Regimens not containing ibalizumab | Epividian, Theratechnologies, FIECON | HIV-1-infection | 02/23 | 02/23 | | |
PROMISE-US, NCT05388474: A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab |
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| Recruiting | N/A | 600 | US | No ibalizumab or Pre-ibalizumab treatment, Ibalizumab, On ibalizumab treatment | Theratechnologies, Excelsus Statistics Inc., Health Psychology Research Group (HPR), ICON Clinical Research | HIV Infections, Multi-Antiviral Resistance | 06/25 | 12/25 | | |
| Arbidol (umifenovir) / Pharmstandard |
NCT04246242: A Randomized Multicenter Controlled Clinical Trial of Arbidol in Patients With 2019 Novel Coronavirus (2019-nCoV) |
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| Not yet recruiting | 4 | 500 | NA | Conventional treatment group, arbidol,200mg,tid, arbidol,400mg,tid | Xiangya Hospital of Central South University | 2019 Novel Coronavirus | 04/20 | 05/21 | | |
ChiCTR2000029592: Clinical Study of Arbidol Hydrochloride Using for Post-exposure Prophylaxis of 2019-nCoV in High-risk Population Including Medical Staff |
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| Not yet recruiting | 4 | 1000 | | Arbidol cohort versus without Arbidol cohort | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, HUST COVID-19 Rapid Response Call (2020kfyXGYJ046） | novel coronavirus pneumonia (COVID-19) | | | | |
ChiCTR1900028586: The Combined Effect of Arbidol Hydrochloride Tablets and Oseltamivir Phosphate Capsules on Influenza Pneumonia |
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| Recruiting | 4 | 110 | | Arbidol + Oseltamivir ;Oseltamivir | Shulan (Hangzhou) Hospital; Shulan (Hangzhou) Hospital, National Science and Technology Major Project (No. 2017ZX10204401) | Influenza Pneumonia | | | | |
ChiCTR2000029621: Clinical study of arbidol hydrochloride tablets in the treatment of novel coronavirus pneumonia (COVID-19) |
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| Recruiting | 4 | 380 | | Arbidol tablets + basic treatment ;Basic treatment | Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Arbidol is provided free of charge by the Shijiazhuang Pharmaceutical Group | novel coronavirus pneumonia (COVID-19) | | | | |
| Recruiting | 4 | 990 | | Abidol 200 mg orally three times a day ;Take placebo three times a day | Shengjing Hospital; Shengjing Hospital, Beijing Medical and Health Foundation | Chronic obstructive pulmonary disease | | | | |
NCT03851991: The Efficacy and Safety of Arbidol in Reducing the Frequency of AECOPD. |
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| Enrolling by invitation | 4 | 990 | RoW | Arbidol, Placebos | Shengjing Hospital | COPD Patients | 10/23 | 10/24 | | |
ChiCTR2000040924: Real-world efficacy and safety of Arbidol in the treatment of influenza-like illness |
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| Recruiting | 4 | 4000 | | Arbidol ;Oseltamivir | Qilu Hospital of Shandong University; Qilu Hospital of Shandong University, Self-financing | Influenza-like illness(ILI) | | | | |
ChiCTR2400080762: Clinical efficacy of Arbidol hydrochloride tablets in the treatment of uncomplicated influenza |
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| Completed | 4 | 100 | | Arbidol hydrochloride tablets, 200MG, three times a day, for 5 days.; Oseltamivir phosphate capsules, 75 mg, twice daily for 5 days. | Beijing Ditan Hospital, Capital Medical University; Beijing Ditan Hospital, Capital Medical University, The CSPC Ouyi Pharmaceutical Co., Ltd. | Influenza | | | | |
NCT05783206: Evaluation of Safety & Efficacy of MIR 19 ® Inhalation Solution in Patients With Mild COVID-19 |
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| Completed | 2/3 | 984 | RoW | MIR 19 ®, Standard therapy | National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia | COVID-19 | 07/23 | 07/23 | | |
ChiCTR-TRC-12001946: Pharmacokinetics of arbidol hydrochloride suspension in healthy Chinese volunteers |
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| Completed | 1 | 24 | | This was a single-dose, open-label, randomized, 3-sequence, crossover study. In accordance with the randomization scheme, subjects were assigned to receive a single 0.2, 0.4 and 0.8 g dose of arbidol hydrochloride suspension with a 7-day washout period between administration. The 3-sequence consisted of equal numbers of men and women. ;Followed single-dose phase , volunteers assigned to continued into the multiple-dose phase, during which they were received the 0.2 g dose three times daily for 7 consecutive days. | Shengjing Hospital of China Medical University; Level of the institution：, Northeast pharmaceutical group Co., Ltd. Shenyang No.1 Pharmaceutical Factory | viral infection | | | | |
ChiCTR2000029759: Retracted due to lack of patient A multicenter, randomized, open label, controlled trial for the efficacy and safety of ASC09/ Ritonavir compound tablets and Lopinavir/ Ritonavir (Kaletra) and Arbidol tablets in the treatm |
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| Suspended | N/A | 60 | | Lopinavir / Ritonavir (Kaletra) and IFN aerosol inhalation ;Abidol and IFN aerosol inhalation. ;ASC09/ Ritonavir (ASC09F) and IFN aerosol inhalation | The Second Affiliated Hospital of Chongqing Medical University; Chongqing Three Gorges Central Hospital, self-financing | Novel Coronavirus Pneumonia (COVID-19) | | | | |
ChiCTR2000029993: A pilot study for Integrated Chinese and Western Medicine in the treatment of non-critical novel coronavirus pneumonia (COVID-19) |
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| Recruiting | N/A | 40 | | Arbidol Hydrochloride Tablets, Liushen Capsule, standard therapy ;standard therapy | The First Affiliated Hospital of Guangzhou Medical University; Guangzhou Institute of Respiratory Health, Shijiazhuang Pharmaceutical Group Co., Ltd./ Lei Yunshang Pharmaceutical Group Co., Ltd. | Novel Coronavirus Pneumonia (COVID-19) | | | | |
| Completed | N/A | 742 | RoW | Cycloferone, paracetamol | POLYSAN Scientific & Technological Pharmaceutical Company | Acute Respiratory Viral Infection | 04/24 | 09/24 | | |
NCT06462417: Efficacy and Safety of Arbidol in the Treatment of Allergic Rhinitis |
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| Not yet recruiting | N/A | 15 | RoW | Arbidol, Arbidol Hydrochloride | Zheng Liu, National Natural Science Foundation of China | Allergic Rhinitis | 06/25 | 06/25 | | |
ChiCTR2400086358: Study on the Efficacy and Safety of Oral Administration of Arbidol in the Treatment of Allergic Rhinitis Patients |
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| Not yet recruiting | N/A | 15 | | Arbidol Hydrochloride Tablets | Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology; Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology, NSFC | Allergic Rhinitis | | | | |
| Evusheld (cilgavimab/tixagevimab) / AstraZeneca |
2022-000905-29: Temporal kinetics of antibody and cellular response markers and relative impact of revaccination in patients recovered from COVID-19 after treatment with monoclonal antibodies Cinetica tempoRale dei marcatori di risposta anticorpale e cEllulare e relativo impatto della rivacciNazione in pazienti guariti dalla COVID-19 dopo trattamento con anticoRpi monoclonali |
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| Not yet recruiting | 4 | 150 | Europe | Evusheld, Xevudy, Comirnaty, Spikevax, Nuvaxovid, [-], Solution for injection, Concentrate for solution for infusion, Dispersion for injection, Evusheld, Xevudy, Comirnaty, Spikevax, Nuvaxovid | ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI" | Covid-19 infection Infezione da Covid-19, Covid-19 infection Infezione da Covid-19, Diseases [C] - Virus Diseases [C02] | | | | |
NCT05982704: Study of Tixagevimab/Cilgavimab and Regdanvimab Efficacy for Treatment of COVID-19 |
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| Active, not recruiting | 4 | 82 | RoW | tixagevimab/cilgavimab 150+150 mg, EVUSHELD 150+150 mg, tixagevimab/cilgavimab 300+300 mg, EVUSHELD 300+300 mg, regdanvimab, REGKIRONA | City Clinical Hospital No.52 of Moscow Healthcare Department, Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation | Coronavirus Infections | 09/22 | 11/23 | | |
2021-006960-26: PROPHYLAXIS OF COVID-19 USING LONG-ACTING ANTIBODIES AGAINST CORONAVIRUS IN PATIENTS WITH REDUCED IMMUNE SYSTEM THAT HAS NOT RESPONDED TO VACCINES |
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| Not yet recruiting | 4 | 200 | Europe | cilgavimab/tiksagevimab, Injection, Evusheld | Oslo University Hospital - Rikshospitalet, AstraZeneca | Kidney transplant recipients with suboptimal immune response to previous SARS-CoV-2 vaccinations, Kidney transplanted patient with to low response to previous corona vaccinations, Diseases [C] - Virus Diseases [C02] | | | | |
| Completed | 3 | 5197 | Europe, US | AZD7442, Combination of 2mAbs(AZD8895 and AZD1061), Placebo | AstraZeneca, Iqvia Pty Ltd | COVID-19 | 08/22 | 12/23 | | |
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NCT05780437: AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) |
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| Completed | 3 | 1455 | Europe, US, RoW | AZD7442, AZD8895 + AZD1061, Placebo, Remdesivir, Veklury | National Institute of Allergy and Infectious Diseases (NIAID), International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, AstraZeneca, University of Minnesota | COVID-19 | 01/22 | 06/23 | | |
| Completed | 3 | 2753 | Europe, US, RoW | LY3819253, Placebo, Remdesivir, VIR-7831, BRII-196/BRII-198, AZD7442, AZD8895 + AZD1061, MP0420, ensovibep, PF-07304814 | National Institute of Allergy and Infectious Diseases (NIAID), International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, AIDS Clinical Trials Group, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Eli Lilly and Company, Vir Biotechnology, Inc., GlaxoSmithKline, Brii Biosciences Limited, AstraZeneca, Molecular Partners AG, Pfizer, University of Minnesota | Covid19 | 04/22 | 07/23 | | |
| Completed | 3 | 1552 | Europe | Remdesivir, Lopinavir/ritonavir, Interferon Beta-1A, Hydroxychloroquine, Standard of care, AZD7442, Placebo | Institut National de la Santé Et de la Recherche Médicale, France | Corona Virus Infection | 07/22 | 09/23 | | |
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NCT05438498: Real World Evaluation of the Effectiveness of AZD7442 for Prevention of SARS-CoV-2 |
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| Terminated | 3 | 550 | US | Evusheld (tixagevimab+cilgavimab) IM or IV, AZD7442 | MediMergent, LLC | SARS-CoV-2 Infection | 04/23 | 06/23 | | |
| Completed | 3 | 536 | Europe | Sotrovimab, Tixagevimab Cilgavimab, Nirmatrelvir Ritonavir | Azienda Ospedaliera Universitaria Integrata Verona, Agenzia Italiana del Farmaco, Azienda Sanitaria-Universitaria Integrata di Udine | COVID-19 | 10/23 | 10/23 | | |
| Completed | 2/3 | 4044 | Canada, US, RoW | bamlanivimab 7000mg, LY3819253, BRII-196+BRII-198, AZD7442 (IV), AZD8895 + AZD1061, AZD7442 (IM), SNG001, Camostat, FOY-305, camostat mesilate, camostat mesylate, BMS-986414 + BMS-986413, C135-LS + C144-LS, SAB-185 (3,840 Units/kg), Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived), SAB-185 (10,240 Units/kg), CASIRIVIMAB + IMDEVIMAB, REGN10933 + REGN10987, REGN-COV2, Placebo for Bamlanivimab 7000mg, Placebo for Bamlanivimab 700mg, Placebo for BRII-196+BRII-198, Placebo for SNG001, Placebo for Camostat, Placebo for SAB-185 (low dose), Placebo for BMS-986414 + BMS-986413, Placebo for AZD7442 (IV), Placebo for AZD7442 (IM), Placebo for SAB-185 (high dose), bamlanivimab 700mg | National Institute of Allergy and Infectious Diseases (NIAID), Eli Lilly and Company, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, Brii Biosciences Limited, AstraZeneca, Sagent Pharmaceuticals, Synairgen Research Ltd., Bristol-Myers Squibb, SAb Biotherapeutics, Inc. | Coronavirus, Covid19 | 04/22 | 06/23 | | |
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| Active, not recruiting | 2/3 | 3882 | Europe, Canada, US, RoW | AZD5156 (Parent study Sentinel Safety Cohort), Placebo (Parent study Sentinel Safety Cohort), EVUSHELD™ (Parent study Main Cohort), EVUSHELD™, AZD3152 (Parent study Main Cohort), Placebo (Parent study Main Cohort), AZD3152 (Sub-study), AZD7442 - EVUSHELD™ (Sub-study), AZD7442 (EVUSHELD™) (Sub-study) Immunocompromised participants offered AZD3152 | AstraZeneca, AstraZeneca AB | COVID-19, SARS-CoV-2 | 03/24 | 02/25 | | |
2021-002927-39: Preventive strategies against SARS-CoV-2 in kidney transplant recipients:Intervention A - vaccination: Study to test if vaccination with Ad26COVS1 or ChAdOx1-S results in a better immune response compared to a third dose of BNT162b2 or mRNA-1273 in kidney transplant recipients who did not develop an immune response following previous vaccination against COVID-19Intervention B - monoclonal SARS-CoV-2 antibody cocktail in kidney transplant recipients not responding to vaccination |
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| Not yet recruiting | 2 | 400 | Europe | EVUSHELD, AZD7442, Suspension for injection, Concentrate for dispersion for injection, Dispersion for injection, Lyophilisate for solution for injection, COVID-19 Vaccine Janssen, Comirnaty, COVID-19 Vaccine Moderna, Vaxzevria | Medical University of Vienna, Medical University of Vienna | Intervention A - vaccinationPatients following kidney transplant recipients who do not have an adequate immune response against SARS-CoV-2 following two doses of an mRNA vaccineSubstudy A: kidney transplant recipients who did not develop antibodies after a fourth doseIntervention B - monoclonal antibodiesKidney transpant recipients who do not develop neutralizing antibodies after at least two doses of SARS-CoV-2 vaccine, Patients following kidney transplant recipients who do not have an adequate immune response against SARS-CoV-2 following vaccination, Diseases [C] - Immune System Diseases [C20] | | | | |
NCT05184062: A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults |
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| Completed | 2 | 272 | RoW | 600 mg AZD7442 IV, AZD7442, 600mg placebo IV, Placebo | AstraZeneca | Coronavirus Disease 2019 (COVID-19) | 08/22 | 05/23 | | |
ENDURE, NCT05375760: A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19 |
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| Terminated | 2 | 251 | US | AZD7442 (tixagevimab [AZD8895] + cilgavimab [AZD1061]) | AstraZeneca | Coronavirus Disease 2019 (COVID-19) | 10/23 | 10/23 | | |
OPTICOV, NCT05587894: OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial |
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| Recruiting | 2 | 256 | Europe | Paxlovid 5 days, Nirmatrevlir/ritonavir, Paxlovid 10 days, Veklury, remdesivir | ANRS, Emerging Infectious Diseases, University Hospital, Geneva | COVID-19, Immunodeficiency | 03/25 | 05/25 | | |
| Withdrawn | 2 | 200 | Canada | EVUSHELD | Sunnybrook Health Sciences Centre, AstraZeneca | Chronic Lymphocytic Leukemia, COVID-19 | 10/24 | 10/25 | | |
NCT05437289: A Study to Evaluate the Safety and Tolerability of AZD7442 in Healthy Chinese Adults |
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| Completed | 1 | 61 | RoW | AZD7442 IM, AZD7442, Placebo IM, Placebo, AZD7442 IV, Placebo IV, Evusheld | AstraZeneca | Coronavirus Disease 2019 (COVID-19), Healthy Volunteer | 11/21 | 01/23 | | |
NCT05406375: Phase I Double-blind, Placebo-controlled Study of AZD7442 |
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| Active, not recruiting | 1 | 40 | Japan | AZD7442 300 mg IM(male), AZD7442 600 mg IM (male), AZD7442 300 mg IV (male and female), AZD7442 1000 mg IV (male) | MedImmune LLC | COVID-19 | 06/22 | 06/22 | | |
NCT05166421: Study to Evaluate Pharmacokinetic Comparability Between AZD7442 Co-formulation (AZD8895 + AZD1061) vs AZD8895 and AZD1061 Individually in Adult Healthy Participants |
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| Completed | 1 | 224 | US | AZD7442, AZD8895 (clonal cell line material), AZD1061 (clonal cell line material), AZD8895 (cell pool material), AZD1061 (cell pool material) | AstraZeneca | Corona Virus Disease | 07/23 | 07/23 | | |
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| Completed | 1 | 46 | Europe, US, RoW | AZD7442, Evusheld | AstraZeneca | SARS-CoV-2 | 04/24 | 04/24 | | |
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| Completed | N/A | 4000 | RoW | EVUSHELD | AstraZeneca, Clalit Health Services | SARS-CoV-2, COVID-19 | 05/23 | 05/23 | | |
CLEAR, NCT05917951: Study on Determine the Utilisation and Clinical Outcomes of Evusheld in COVID-19 PrEP in China |
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| Completed | N/A | 248 | RoW | | AstraZeneca | COVID-19 | 07/23 | 07/23 | | |
| Completed | N/A | 4232 | US | EVUSHELD | AstraZeneca, University of Pittsburgh | SARS-CoV-2, COVID-19 | 07/23 | 07/23 | | |
| Completed | N/A | 5814 | US | Evusheld | AstraZeneca, VA Informatics and Computing Infrastructure (VINCI) | SARS-CoV-2, COVID-19 | 09/23 | 09/23 | | |
CLL2423, NCT05803395: Incidence of Severe COVID-19 Infection in Patients With CLL or B-NHL Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy. |
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| Recruiting | N/A | 954 | Europe | | Gruppo Italiano Malattie EMatologiche dell'Adulto, Fondazione Italiana Linfomi | Chronic Lymphocytic Leukemia, Indolent B-Cell Non-Hodgkin Lymphoma, COVID-19 | 09/24 | 09/24 | | |
