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"}}},"trialDetailsJson":{"title":"Details Page","returnSearch":"Back to search results","description":"Study Description","identifier":"ViiV Study ID","clinicalID":"Clinicaltrials.gov Identifier","EudraCtID":"EudraCT Number","resultsAvailable":"Has Results Available Below","docAvailable":"Has Results Document Available","studyOverview":"Study Overview","overviewSection":{"conditionsDisplay":"Medical Conditions","product":"Product","collaborators":"Collaborators","dates":"Date","studyType":"Type","phase":"Phase","gender":"Gender","age":"Age","acceptVolunteers":"Accepts Healthy Volunteers"},"studyDocuments":"Study Documents","noDocuments":"No documents available","studyDocumentsAdditionalText":"If you wish to request for Full Study Report, please contact - ","studyDocumentsAdditionalEmail":"GSKClinicalSupportHD@gsk.com","isReleased":{"firstPart":"This study has Protocol and Result summary on ClinicalTrial.gov. Click","secondPart":"to learn more.","linkText":"here"},"mapLocations":"Locations","centralContact":"Central Contact","centralPhone":"Central Contact Phone","centralEmail":"Central Contact Email","mapSection":{"site":"GSK Investigational Site","condition":"Condition","id":"Study ID","city":"City","state":"State","zip":"Zip","country":"Country"},"studyDesign":"Study Design","designSection":{"purpose":"Primary Purpose","allocation":"Allocation","study_design":"Study Design","study_classification":"Study Classification","masking":"Masking","masked_subject":"Masked Subject","masked_caregiver":"Masked Caregiver","masked_investigator":"Masked Investigator","masked_assessor":"Masked Assessor","primary_outcomes":"Primary Outcomes","secondary_outcomes":"Secondary Outcomes","arms":"Arms","interventions":"Interventions","keyword":"Keyword","inclusionTitle":"Inclusion Criteria","exclusionTitle":"Exclusion Criteria","criteriaText":"Inclusion/Exclusion Criteria","criteria_button":"Click to view inclusion/exclusion criteria","enrollment":"Enrollment","clinicalPublications":"Clinical Publications"},"popoversText":{"studyId":{"childMarkdownRemark":{"html":"A unique number for a study given by ViiV.
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"}}}},"site":{"siteMetadata":{"siteUrl":"https://www.viiv-studyregister.com"}},"studyDetails":{"nct_number":"NCT04233047","ctis_id":"","HasResults":"false","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"false","IpdInfoTypeIcf":"false","IpdInfoTypeCsr":"false","IpdInfoTypeProtocol":"false","IpdInfoTypeSap":"false","IpdTimeFrame":"","IpdUrl":"","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"","masked_caregiver":"","masked_investigator":"","masked_subject":"","masking_description":"","no_masking":""},"PatientLevelData":"true","SharingIpd":"No","acronym":"","allocation":"","arm_groups":[],"assignment":"","brief_summary":"Compassionate use access to fostemsavir (GSK3684934, formerly BMS-663068) for the treatment of HIV infection in individuals with multidrug resistant HIV-1 infection who are experiencing virologic failure and are unable to comprise a suppressive regimen with currently available antiretrovirals.\nDirect inquires to the ViiV Compassionate Use Portal via https://viiv-cu-portal.idea-point.com/","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Fostemsavir Compassionate Use Named Patient Program for the Treatment of Human Immunodeficiency Virus 1 (HIV-1)","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"HIV infections","LookupValue_OneLinkTx":""}],"created_date":"04/29/2021 14:55:12","criteria":"Inclusion Criteria:\n \n1.\tPatient has given consent for treatment\n2.\tPatient is male or non-pregnant female, age 18 years and older. NOTE: there may be allowance for a lower minimum age if dictated by local regulatory and/or legal requirements.\n3.\tPatient has chronic HIV-1 infection and is heavily treatment experienced \n4.\tPatient is experiencing virologic failure (confirmed HIV-1 RNA ≥1000 c/mL) on a current antiretroviral therapy (ART) regimen and:\na)\tis unable to comprise a suppressive regimen without fostemsavir due to documented multi-drug resistance test results and/or intolerance and/or contraindication AND\nb)\thas no more than 2 fully active ART agents (0, 1, or 2 ART agents) which can be paired with fostemsavir as part of a viable combination ART regimen\n5.\tPatient meets the following reproductive status criteria:\na)\tWomen must not be breastfeeding\nb)\tWomen of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of fostemsavir and must agree to periodic pregnancy testing (as per local standard of care) for the duration of treatment with fostemsavir. \nc)\tWOCBP must agree to use at least 1 method of effective contraception for the duration of treatment with fostemsavir and 60 hours after fostemsavir drug exposure. Males must inform their female partners who are WOCBP of the contraceptive requirements of the NPP to which they too are expected to adhere.\nd)\tMales who are sexually active with WOCBP must use condoms for the duration of treatment with fostemsavir and 60 hours after last dose. In addition, males must be willing to refrain from sperm donation during this time.\ne)\tWOCBP who are continuously not heterosexually active are exempt from contraceptive requirements but must comply with the pregnancy testing schedule as outlined in inclusion criterion 5b.\nPhysicians shall counsel WOCBP and males who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. At a minimum, contraceptive counselling should be provided at the time of consent. \n\n\nExclusion Criteria:\n\nPatients will not be eligible for fostemsavir compassionate use if any of the following criteria apply:\n1.\tPatient is eligible to access commercial fostemsavir or investigational fostemsavir by means other than the named patient program.\n2.\tPatient is taking one or more prohibited medications including:\na)\tstrong CYP3A inducers including, but not limited to: carbamazepine, phenytoin (anticonvulsants), mitotane (antineoplastic), enzalutamide (androgen receptor inhibitor), rifampicin (antimycobacterial) and St John’s wort (Hypericum perforatum, herbal supplement),\nb)\telbasvir/grazoprevir (hepatitis C direct acting antiviral)\n\n3.\tPatient has a prior history of poor adherence with multiple failed attempts of oral ART","detailed_description":"Fostemsavir (FTR) is the prodrug of temsavir (TMR), which is a novel, first-in-class attachment inhibitor being developed as a potential treatment of HIV-1 infection. Investigational FTR is being made available on a compassionate use named patient basis for the treatment of HIV infection in individuals with multidrug resistant HIV-1 infection who are experiencing virologic failure (confirmed HIV-1 RNA ≥1000 c/mL) and are unable to comprise a suppressive regimen with currently available antiretrovirals. Such patients, who are often heavily treatment experienced (HTE), represent a small and highly vulnerable subgroup within the overall HIV patient population. The care of HTE patients is difficult and often complicated by the presence of complex comorbidities, extensive concomitant medication profiles, and advanced HIV disease.","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"N/A","display_phase_internal":"PHASE_NA","display_status":"Available","display_status_internal":"RECSTATUS_EA_AVAILABLE","endpoint":"","enrollment":"","exclusion":"","gender":"All","gender_based":"No","gender_description":"","healthy_volunteers":"","id":"2d1bbe97-0e73-531b-bb3f-d29475b07f25","internal":{"content":null,"contentDigest":"b13a91b9e151d9a57eff0f88298a5d48","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria:\n \n1.\tPatient has given consent for treatment\n2.\tPatient is male or non-pregnant female, age 18 years and older. NOTE: there may be allowance for a lower minimum age if dictated by local regulatory and/or legal requirements.\n3.\tPatient has chronic HIV-1 infection and is heavily treatment experienced \n4.\tPatient is experiencing virologic failure (confirmed HIV-1 RNA ≥1000 c/mL) on a current antiretroviral therapy (ART) regimen and:\na)\tis unable to comprise a suppressive regimen without fostemsavir due to documented multi-drug resistance test results and/or intolerance and/or contraindication AND\nb)\thas no more than 2 fully active ART agents (0, 1, or 2 ART agents) which can be paired with fostemsavir as part of a viable combination ART regimen\n5.\tPatient meets the following reproductive status criteria:\na)\tWomen must not be breastfeeding\nb)\tWomen of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of fostemsavir and must agree to periodic pregnancy testing (as per local standard of care) for the duration of treatment with fostemsavir. \nc)\tWOCBP must agree to use at least 1 method of effective contraception for the duration of treatment with fostemsavir and 60 hours after fostemsavir drug exposure. Males must inform their female partners who are WOCBP of the contraceptive requirements of the NPP to which they too are expected to adhere.\nd)\tMales who are sexually active with WOCBP must use condoms for the duration of treatment with fostemsavir and 60 hours after last dose. In addition, males must be willing to refrain from sperm donation during this time.\ne)\tWOCBP who are continuously not heterosexually active are exempt from contraceptive requirements but must comply with the pregnancy testing schedule as outlined in inclusion criterion 5b.\nPhysicians shall counsel WOCBP and males who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. At a minimum, contraceptive counselling should be provided at the time of consent. \n\n\nExclusion Criteria:\n\nPatients will not be eligible for fostemsavir compassionate use if any of the following criteria apply:\n1.\tPatient is eligible to access commercial fostemsavir or investigational fostemsavir by means other than the named patient program.\n2.\tPatient is taking one or more prohibited medications including:\na)\tstrong CYP3A inducers including, but not limited to: carbamazepine, phenytoin (anticonvulsants), mitotane (antineoplastic), enzalutamide (androgen receptor inhibitor), rifampicin (antimycobacterial) and St John’s wort (Hypericum perforatum, herbal supplement),\nb)\telbasvir/grazoprevir (hepatitis C direct acting antiviral)\n\n3.\tPatient has a prior history of poor adherence with multiple failed attempts of oral ART","interventions":[{"arm_group_label":"","intervention_description":"Fostemsavir 600 mg extended release tablets, administered 600 mg twice daily, will be supplied for compassionate use for the identified individual patient.","intervention_name":"Fostemsavir","intervention_type":"Drug"}],"interventional_subtype":"","is_fda_regulated":null,"is_high_value":false,"is_ind_study":null,"keywords":["Human Immunodeficiency Virus 1 (HIV-1)"],"last_follow_up_date":null,"links":[],"locations":[],"masking":"","maximum_age_raw":"N/A","maximum_age":"N/A","minimum_age":"18","minimum_age_raw":"18 Years","modified_date":"04/29/2021 14:55:12","number_of_arms":"","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"official_title":"Fostemsavir Compassionate Use Named Patient Program for the Treatment of Human Immunodeficiency Virus 1 (HIV-1)","org_study_id":"207214","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Available","oversight_info":{"exported_from_us":"","fda_regulated_device":"","fda_regulated_drug":"","ped_postmarket_surv":"","has_dmc":null,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"N/A","primary_compl_date":null,"primary_outcomes":[],"product_name":"fostemsavir","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":null,"outcome_measure":null,"outcome_time_frame":null,"outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":[]},"start_date":null,"study_type":"Expanded Access","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":null}},"pageContext":{"studyId":"207214"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}