[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hsv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hsv":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,53,138,168],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":4,"leadSponsor":49,"locationsCount":52},"100133849","the-natural-history-of-severe-viral-infections-and-characterization-of-immune-defects-in-patients-without-known-immunocompromise-100133849",false,"NCT01011712","The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise","The Natural History of Severe Viral Infections and Characterization of Immune Defects","* INCLUSION CRITERIA:\n\n(Participants)\n\nParticipants must meet all the following inclusion criteria in order to participate in this study:\n\n1. Children or adults (regardless of age) with a definitively diagnosed severe or unusual viral infection, including but not limited to infections caused by herpesviruses (HSV-1, HSV-2, CMV, EBV, VZV, HHV-6, HHV-7, HHV-8), human papillomavirus (e.g., severe recalcitrant warts), adenovirus, calicivirus (e.g. norovirus), polyomavirus (such as JC virus and BK virus), or influenza virus. Viral infections that would be considered opportunistic-like , such as herpesvirus esophagitis, herpesvirus encephalitis, CMV colitis, or progressive multifocal leukoencephalopathy (caused by the JC polyoma virus) will be of particular interest in this protocol.\n\n   OR\n\n   Children or adults with a well-documented prior, severe, persistent, or treatment-refractory viral infection(s), who have clinically recovered from the viral infection.\n2. Ongoing care by a referring physician.\n3. Willingness to allow storage of blood and tissue samples for future analyses.\n\n(Relatives)\n\nRelatives (2 years or above) may be recruited and enrolled to improve interpretation of genetic results, to expand the phenotype of the suspected or confirmed inborn error of immunity in the proband with severe viral infection, and to understand the co-factors in affected and\u002For unaffected family members that may influence variable expressivity and penetrance of viral infections in inborn errors of immunity.\n\n1. Males and females will be accepted.\n2. Relatives may either be healthy or have features concerning for an inborn error of immunity including, but not limited to, autoimmunity, severe atopy, other forms of immune-dysregulation, or severe or unusual infections. While the enrolled proband must have a current or prior severe or unusual viral infection, family members who are suspected to have an inborn error of immunity do not need to have a history of severe or unusual viral infection in the presence of other features suspicious for inborn errors of immunity.\n3. Adult relatives or the guardians of minor relatives must be willing and capable of providing informed consent after review of protocol procedures that are described in the consent form with an appropriate study team member.\n4. Participating relatives agree to have blood stored for future studies of the immune system.\n\nEXCLUSION CRITERIA:\n\nParticipants meeting any of the following exclusion criteria at baseline will be excluded from study participation:\n\n1. Patients with previously diagnosed conditions associated with acquired or iatrogenic immunodeficiency and\u002For immunosuppresion (e.g., a history of HIV infection, a positive test for HIV, chemotherapy or high dose glucocorticoids). Patients on immunosuppression and\u002For immunomodulatory therapy for the treatment of conditions that may be attributable to an underlying inborn error of immunity may be included in the study at the discretion of the PI or their designee.\n2. Women who are pregnant.\n3. Any condition or major comorbidity that the study investigators believe will compromise the patient's ability to comply with the requirements of the study.","ALL","2 Years","100 Years",{"count":20,"type":21},600,"ESTIMATED","OBSERVATIONAL","Background:\n\n* Infections caused by viruses are common causes of illnesses: the common cold, many ear infections, sore throats, chicken pox, and the flu are caused by different viruses. Usually, these illnesses last only few days or, at most, a few weeks. Some virus infections like influenza are cleared from the body, and others such as the chicken pox virus remain in the body in an inactive state. However, some people may become quite ill when they are infected with a particular virus, possibly because part of their immune system does not respond properly to fight the virus.\n* Researchers have discovered some reasons why a person may not be able to clear an infection caused by a virus. Some persons have changes in the genes that involve the immune system that result in the inability to properly control infection with a particular virus. Identifying changes in genes that involve the immune system should help scientists better understand how the immune system works to protect people from infection and may help develop new therapies.\n\nObjectives:\n\n* To study possible immune defects that may be linked to a particular severe viral infection.\n* To determine if identified immune defects are genetic in origin.\n\nEligibility:\n\n* Individuals of any age who have or have had a diagnosis of a virus infection that physicians consider to be unusually severe, prolonged, or difficult to treat.\n* Relatives of the participants with a severe viral infection may also participate in the study. We will use their blood and\u002For skin specimens to try to determine if identified immune defects are hereditary.\n\nDesign:\n\n* Prior to the study, the participant's doctor will give researchers the details of the infection, along with medical records for review. Eligible participants will be invited to the NIH Clinical Center for a full evaluation as an outpatient or inpatient.\n* At the Clinical Center, participants will be treated with the best available therapy for the particular viral infection, and researchers will monitor how the infection responds to the treatment.\n* Researchers will take intermittent blood samples and conduct other tests (such as skin biopsies) to evaluate the immune system. - During and after the illness, researchers will conduct follow-up visits to determine the course of infection and response to therapy.",[25,26,27,28,29],"EBV","HSV","VZV","HPV","CMV",[31,32,33,34,35,36,37,38,39,40,41],"Genetics","Virus","Defense","Immunity","Immunodeficiency","Natural History","Respiratory Viruses","Herpesvirus","Cytomegalovirus","Human Papillomavirus","Adenovirus","RECRUITING","2026-06-17",{"date":45,"type":46},"2026-06-18","ACTUAL",{"date":48,"type":46},"2009-10-01",{"name":50,"class":51},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":100,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":137},"100355699","phase-1-hsv-g207-in-children-with-recurrent-or-refractory-cerebellar-brain-tumors-100355699","NCT03911388","HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors","Phase 1 Trial of Engineered HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors","Inclusion Criteria:\n\n* Age ≥ 36 months and \\\u003C 22 years\n* Pathologically proven malignant cerebellar brain tumor (including medulloblastoma, glioblastoma multiforme, giant cell glioblastoma, anaplastic astrocytoma, primitive neuroectodermal tumor, ependymoma, atypical teratoid\u002Frhabdoid tumor, germ cell tumor, or other high-grade malignant tumor) which is progressive or recurrent despite standard care including surgery, radiotherapy, and\u002For chemotherapy. A pathologically proven secondary malignant cerebellar tumor without curative treatment options is eligible.\n* Lesion must be ≥ 1.0 cm ≤ 3.0 cm in diameter and surgically accessible as determined by MRI. Larger tumors may be surgically debulked and treated if ≤ 3.0 cm after debulking\n* Patients must have fully recovered from acute treatment related toxicities of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study.\n* Myelosuppressive chemotherapy: patients must have received their last dose at least 3 weeks prior (or at least 6 weeks if nitrosurea)\n* Investigational\u002FBiologic agents: patients must have recovered from any acute toxicities potentially related to the agent and received last dose ≥ 7 days prior to entering this study (this period must be extended beyond the time during which adverse events are known to occur for agents with known adverse events ≥ 7 days). For viral therapy, patients must have received viral therapy ≥ 3 months prior to study entry and have recovered from all acute toxicities potentially related to the agent.\n* Monoclonal antibodies: The patient must have received last dose ≥ 21 days prior.\n* Radiation: Patients must have received their last fraction of craniospinal radiation (\\>24 Gy) or total body irradiation ≥ 3 months prior to study entry. Patients must have received focal radiation to symptomatic metastatic sites or local palliative radiation ≥ 28 days prior to study entry.\n* Autologous bone marrow transplant: Patients must be ≥ 3 months since transplant prior to study entry.\n* Normal hematological, renal and liver function (absolute neutrophil count \\> 1000\u002Fmm3, platelets \\> 100,000\u002Fmm3, prothrombin time (PT) or partial thromboplastin time (PTT) \\\u003C 1.3 x control, creatinine within normal institutional limits OR creatinine clearance \\>60 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal, total bilirubin \\\u003C 1.5 mg\u002Fdl, transaminases \\\u003C 3 times above the upper limits of the institutional norm)\n* Patients \\\u003C 16 years, Modified Lansky performance score ≥ 60; patients ≥ 16 years, Karnofsky performance score ≥ 60\n* Patient life expectancy must be at least 8 weeks\n* Written informed consent in accordance with institutional and FDA guidelines must be obtained from patient or legal guardian\n\nExclusion Criteria:\n\n* Any treatment outside the allowable guidelines outlined in section 5.1.\n* Diffuse, widespread, abnormal tumor pattern involving 3 or more lobes of the brain\n* Acute infection, granulocytopenia or medical condition precluding surgery\n* Pregnant or lactating females\n* Diagnosis of encephalitis or CNS infection \\\u003C 3 months prior, or receiving ongoing treatment for encephalitis, CNS infection or multiple sclerosis\n* Tumor involvement which would require ventricular or brainstem inoculation or would require access through a ventricle in order to deliver treatment\n* Required steroid increase within 1 week prior to G207 inoculation or patients requiring \\>2 mg of dexamethasone daily\n* Known HIV seropositivity\n* Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, gancyclovir, foscarnet, cidofovir) or any immunosuppressive drug therapy (except dexamethasone or prednisone).\n* Other current malignancy\n* Concurrent anticancer or investigational drug","3 Years","21 Years",{"count":63,"type":21},24,"INTERVENTIONAL",[66],"PHASE1","This study is a clinical trial to determine the safety of inoculating G207 (an experimental virus therapy) into a recurrent or refractory cerebellar brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication, tumor cell killing, and an anti-tumor immune response, will also be tested.\n\nFunding Source- FDA OOPD",[69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,26,32,97,98,99],"Neoplasms, Brain","Glioblastoma Multiforme","Glioblastoma of Cerebellum","Neoplasms","Astrocytoma","Astrocytoma, Cerebellar","Neuroectodermal Tumors","Neuroectodermal Tumors, Primitive","Cerebellar PNET, Childhood","Cerebellar Neoplasms","Cerebellar Neoplasms, Primary","Cerebellar Neoplasm, Malignant","Cerebellar Neoplasm Malignant Primary","Neoplasm Metastases","Neoplasm Malignant","Neoplasms, Neuroepithelial","Neoplasms, Germ Cell and Embryonal","Neoplasms by Histologic Type","Neoplasms, Glandular and Epithelial","Neoplasms, Nerve Tissue","Central Nervous System Neoplasms, Primary","Central Nervous System Neoplasms, Malignant","Nervous System Neoplasms","Neoplasms by Site","Brain Diseases","Central Nervous System Diseases","Nervous System Diseases","Medulloblastoma Recurrent","Pediatric Brain Tumor","Nervous System Cancer","Primitive Neuroectodermal Tumor (PNET) of Cerebellum",[101,102,70,103,104,105,106,107,108,109,110,111,112,113,114,115,72,116,117,118,119,120,121,122,123,32,26,124,125,126],"Brain Tumor, Recurrent","Glioma","Gliosarcoma","Medulloblastoma","Anaplastic Astrocytoma","Oligodendroglioma","Rhabdoid Tumor","Ependymoma","Germ Cell Tumor","Choroid Plexus Carcinoma","Cerebral Primitive Neuroectodermal Tumor","Giant Cell Glioblastoma","Atypical teratoid\u002Frhabdoid tumor","Secondary Malignant Cerebellar Tumor","Embryonal Tumor","Oncolytic Virus Therapy","Virotherapy, Oncolytic","Immunotherapy","Central Nervous System Agents","Antineoplastic Agents","Pediatric","Pediatrics","Oncolytic","Herpes Virus","G207","Oncolytic Herpes Virus","2026-05-13",{"date":129,"type":46},"2026-05-15",{"date":131,"type":46},"2019-09-12",{"date":133,"type":21},"2027-09-01",{"name":135,"class":136},"M.D. Anderson Cancer Center","OTHER",3,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":64,"phases":149,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":52},"100595453","phase-2-evaluating-benzoyl-peroxide-for-preventing-recurrence-of-hsv-1-outbreaks-with-rescue-crossover-option-100595453","NCT07032649","Evaluating Benzoyl Peroxide for Preventing Recurrence of HSV-1 Outbreaks With Rescue Crossover Option","Double-Blind, Placebo-Controlled Clinical Trial Evaluating Benzoyl Peroxide for Preventing Recurrence of HSV-1 Outbreaks With Rescue Crossover Option","Inclusion Criteria:\n\nAdults aged 18-65 years, inclusive.\n\nDocumented history of at least two HSV-1 outbreaks per year.\n\nAbility and willingness to participate fully via telehealth (including video visits).\n\nMust provide informed consent to participate in the trial.\n\nAbility to comply with the trial protocol, including symptom reporting, topical cream application, and follow-up telehealth appointments.\n\nExclusion Criteria:\n\nCurrently pregnant or breastfeeding, or plans to become pregnant during the study period.\n\nKnown allergy or sensitivity to benzoyl peroxide or similar topical agents.\n\nCurrent participation in another clinical trial involving topical treatments.\n\nMedical conditions or skin conditions that could significantly interfere with topical treatment application or safety assessment.\n\nInability to effectively participate in telehealth visits or use video-based symptom verification.\n\nParticipants who, in the opinion of the investigator, are unlikely to comply fully with trial requirements or complete the 6-month follow-up period.","18 Years","65 Years",{"count":148,"type":21},100,[150],"PHASE2","Here's a clear, concise, and accurate \\*\\*brief summary\\*\\* suitable for your ClinicalTrials.gov PRS submission:\n\n* Brief Summary:\n\nThis randomized, double-blind, placebo-controlled clinical trial evaluates the effectiveness of topical Benzoyl Peroxide (10%) in preventing recurrent oral lesions caused by Herpes Simplex Virus Type 1 (HSV-1). Participants who experience frequent HSV-1 outbreaks will be randomly assigned to either Benzoyl Peroxide or placebo treatment. The trial will be conducted via telehealth visits, with treatment provided remotely. The primary objective is to determine whether Benzoyl Peroxide significantly delays or prevents HSV-1 lesion recurrence compared to placebo. Secondary outcomes include evaluating recurrence frequency, lesion severity, healing duration, and participant satisfaction. The trial also incorporates a rescue crossover step, allowing placebo-group participants who experience recurrence to receive active treatment. Results from this pilot study will inform the potential use of Benzoyl Peroxide as a novel, accessible topical treatment option for recurrent HSV-1 outbreaks.",[26],[26,154,155,156],"HSV-1","HSV suppression","Herpes","NOT_YET_RECRUITING","2025-08-04",{"date":160,"type":46},"2025-08-05",{"date":162,"type":21},"2026-01-01",{"date":164,"type":21},"2027-07",{"name":166,"class":167},"Greg Bew","INDUSTRY",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":174,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":175,"phases":4,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":178,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":182,"locationsCount":4},"100504142","expanded-access-intermediate-size-treatment-protocol-pritelivir-for-immunocompromised-subjects-with-treatment-resistant-herpes-simplex-virus-type-1-or-2-100504142","NCT05844436","Expanded Access Intermediate Size Treatment Protocol: Pritelivir for Immunocompromised Subjects with Treatment Resistant Herpes Simplex Virus Type 1 or 2","Main Inclusion Criteria:\n\n1. Immunocompromised (due to conditions including but not limited to HIV infection, hematopoietic-cell or solid organ transplantation, and chronic use of immunosupressive treatment) men and women of any ethnic group aged ≥16 years.\n2. ACV-resistant and foscarnet-resistant\u002Fintolerant mucocutaneous HSV infection based on clinical failure (no improvement after oral or iv doses for at least 7 days at doses equivalent to or greater than the local agency approved high doses of valacyclovir or famciclovir and\u002For foscarnet iv therapy or intolerance to foscarnet requiring cessation of foscarnet treatment) or result from genotypic\u002Fphenotypic testing or ACV-resistant and previously treated in PRIOH-1 Part C.\n3. The current lesion(s) should be confirmed to be positive for HSV before the start of treatment. If not tested beforehand, a lesion swab should be taken for PCR or cell culture before starting treatment, but treatment may be started before obtaining results.\n4. Visual confirmation of lesion at start of treatment (including by endoscopy).\n5. Willing to remain abstinent or use highly effective method of contraception.\n6. Negative pregnancy test for females of childbearing potential at Day 1 and every 4 weeks thereafter.\n7. Patient must be willing and able (in the opinion of the physician) to understand the informed consent form.\n8. Patient must give written informed consent.\n\nMain Exclusion Criteria:\n\n1. Eligibility and feasibility for a patient to participate in a currently ongoing clinical trial with pritelivir.\n2. Known intolerance to pritelivir or any of the excipients (microcrystalline cellulose, croscarmellose sodium, mannitol, colloidal anhydrous silica, magnesium stearate, hydroxy propyl methyl cellulose, polyethylene glycol, calcium diphosphate).\n3. Need to use the following medications at any dose: esomeprazole, rabeprazole. Need to use the medications with the following daily dose levels: omeprazole \\> 20 mg\u002Fd, lansoprazole \\> 20 mg\u002Fd or pantoprazole \\> 80 mg\u002Fd.\n4. Baseline safety laboratory abnormalities:\n\n   1. ANC \\\u003C 1000 cells\u002Fmm3\n   2. Platelet count \\\u003C 25,000 cells\u002Fmm3\n   3. Hemoglobin \\\u003C 8.0 g\u002FdL\n   4. AST or ALT \\> 5 x ULN\n   5. Bilirubin \\> 2.5 x ULN\n5. History or current evidence of gastrointestinal malabsorption which, in the opinion of the physician, may affect the extent of absorption of pritelivir.\n6. Hemodialysis for any indication and ESRD (eGFR \\\u003C15 mL\u002Fmin; stage 5 CKD).\n7. History or current evidence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other diseases, which, in the opinion of the physician, may affect the patient's safety.\n8. Abnormalities in hematological, clinical chemical or any other laboratory variables regarded as clinically relevant by the physician unless they are due to underlying disease or condition.\n9. Not able to communicate meaningfully with the physician and site staff.\n10. Any other condition which in the opinion of the physician would interfere with successful completion of the treatment.\n11. Pregnant and\u002For breastfeeding women.","16 Years","EXPANDED_ACCESS","AiCuris Anti-infective Cures AG (AiCuris) is developing pritelivir for the oral treatment of acyclovir-resistant (ACV-R) mucocutaneous herpes simplex virus (HSV) infections in immunocompromised subjects.\n\nThe purpose of the expanded access program (EAP) is to provide pritelivir to immunocompromised subjects with treatment resistant HSV type 1 or 2 who cannot participate in a clinical trial and for whom no approved treatment option is available.\n\nIn view of the available pre-clinical and clinical data for pritelivir in immunocompromised subjects with treatment resistant HSV, the lack of treatment options, and the demand for compassionate use of pritelivir, AiCuris aims to provide access to pritelivir via this expanded access program (intermediate size treatment protocol) in the USA. The patient population is focused on those immunocompromised subjects that are not responding to the available FDA-approved antiviral options or cannot use these because of an underlying medical condition. This EAP enables pritelivir to be available as a treatment option for immunocompromised subjects with treatment-resistant HSV type 1 or 2, who do not have access to clinical trial options.",[26],"AVAILABLE","2025-02-06",{"date":181,"type":46},"2025-02-10",{"name":183,"class":167},"AiCuris Anti-infective Cures AG"]