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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.
"}},"ctGov":{"childMarkdownRemark":{"html":"This number identifies the study on the US clinicaltrials.gov register. Click this link to go to the entry for this study on Clinicaltrials.gov where you will be able to see protocol and results summaries where available.
"}},"eudraCT":{"childMarkdownRemark":{"html":"This number identifies the study on the EU clinicaltrials.eu register. Click this link to go to the entry for this study on clinicaltrials.eu where you will be able to see protocol and results summaries where available.
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Details on GSK’s data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"True","IpdInfoTypeCsr":"True","IpdInfoTypeProtocol":"True","IpdInfoTypeSap":"True","IpdTimeFrame":"Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.","IpdUrl":"https://www.gsk.com/en-gb/innovation/trials/data-transparency/","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"true","masked_caregiver":"true","masked_investigator":"true","masked_subject":"true","masking_description":"","no_masking":"false"},"PatientLevelData":"false","SharingIpd":"Yes","acronym":"","allocation":"Randomized","arm_groups":[{"arm_group_label":"Participants receiving VH3739937","arm_group_description":"","arm_type":"Experimental"},{"arm_group_label":"Participants receiving Placebo","arm_group_description":"","arm_type":"Placebo Comparator"},{"arm_group_label":"VH3739937 Low Dose Group","arm_group_description":"Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. 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for all participants within the range 18.5-35.0 kilogram per meter square (kg/m^2).\n - Capable of giving signed informed consent\n - Participant must be willing and able to start Combination Antiretrovial Therapy (cART) as selected with the Investigator on Study Day 8 (except in the case of early termination, clinically relevant AE/SAE, lab abnormality, the withdrawal of consent, lost to follow-up, etc., where circumstances could dictate otherwise).\n\nExclusion Criteria:\n - Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)\n - Participants with primary HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion\n - Myocardial infarction, acute coronary syndrome, unstable angina, stroke, 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Complete"},{"City":"Madrid","Latitude":"40.4351996","CountryDisplay":"Spain","Longitude":"-3.68134","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"28006","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Madrid","Latitude":"40.4770721","CountryDisplay":"Spain","Longitude":"-3.9164585","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"28222","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Vitoria","Latitude":"42.8591656","CountryDisplay":"Spain","Longitude":"-2.6817918","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"1009","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Newark","Latitude":"40.7350747","CountryDisplay":"United States","Longitude":"-74.1739057","Name":"GSK Investigational 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Tolerability and Pharmacokinetics of VH3739937 in Treatment-Naïve Adults Living with HIV-1","org_study_id":"212580","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Terminated (Halted Prematurely) - Interventional","oversight_info":{"exported_from_us":"No","fda_regulated_device":"No","fda_regulated_drug":"Yes","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"Phase 2","primary_compl_date":"08/27/2024 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Maximum Change from Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)","outcome_time_frame":"Baseline (Day 1) and up to Day 8","outcome_safety_issue":null},{"outcome_description":"Plasma samples were collected for the quantitative analysis of plasma HIV-1 RNA. The maximum change from baseline was calculated by determining the largest change from baseline value across all assessment timepoints. This is identified by subtracting the lowest post-dose visit value up to Day 8 (inclusive) from the baseline value. The baseline was defined as the most recent pre-dose assessment with a valid, non-missing value, including measurements from any unscheduled visits.","outcome_measure":"Maximum Change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA).","outcome_time_frame":"From Day 1 to Day 8","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[{"id":"2023-505780-37-00","id_type":"Other Identifier","id_domain":"European Medicines Agency"}],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"Number of Participants with Serious Adverse Events, Deaths, or Adverse Events leading to Discontinuation","outcome_time_frame":"Up to Day 8","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Maximum observed concentration of VH3739937 at Day 1","outcome_time_frame":"Day 1","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to maximum observed concentration (Tmax) of VH3739937 at Day 1","outcome_time_frame":"Day 1","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Concentration at 24 hours (h) post dose of VH3739937 at Day 1","outcome_time_frame":"Day 1","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Area under the concentration-time curve from zero to 24h of VH3739937 at Day 1","outcome_time_frame":"Day 1","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Maximum observed concentration of VH3739937 at steady state","outcome_time_frame":"Day 7","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to maximum observed concentration (Tmax) of VH3739937 at steady state","outcome_time_frame":"Day 7","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Concentration at 24 h post dose of VH3739937 at steady state","outcome_time_frame":"Day 7","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Area under the concentration-time curve from zero to 24h of VH379937 at steady state","outcome_time_frame":"Day 7","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Maximum observed concentration of VH3739937 after single dose","outcome_time_frame":"Up to 168 hours","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to maximum observed concentration (Tmax) of VH3739937 after single dose","outcome_time_frame":"Up to 168 hours","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Area under the concentration-time curve of VH3739937 from zero to 168h after single dose","outcome_time_frame":"Up to 168 hours","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Concentration of VH3739937 at 168 h after single dose","outcome_time_frame":"At 168 hours","outcome_safety_issue":null},{"outcome_description":"An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.","outcome_measure":"Number of Participants with Serious Adverse events (SAEs) during Study Intervention Period","outcome_time_frame":"From Day 1 to Day 8","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of Reported Deaths","outcome_time_frame":"From Day 1 to Day 8","outcome_safety_issue":null},{"outcome_description":"An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have discontinued from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of last contact.","outcome_measure":"Number of participants with Adverse Events (AEs) leading to Discontinuation","outcome_time_frame":"From Day 1 to Day 8","outcome_safety_issue":null},{"outcome_description":"Blood samples were collected at indicated timepoints for PK analysis.","outcome_measure":"Maximum observed plasma concentration (Cmax) of VH3739937 on QD dosing","outcome_time_frame":"Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 1","outcome_safety_issue":null},{"outcome_description":"Blood samples were collected at indicated timepoints for PK analysis. Tmax is defined as the time to reach maximum observed plasma concentration (Cmax).","outcome_measure":"Time to maximum concentration (Tmax) of VH3739937 on QD dosing","outcome_time_frame":"Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 1","outcome_safety_issue":null},{"outcome_description":"C24 is defined as concentration at nominal time of 24 hours after dosing. Blood samples were collected at indicated timepoints for PK analysis.","outcome_measure":"Concentration at 24 hours (C24) post dose of VH3739937 on QD dosing","outcome_time_frame":"At 24h post-dose on Day 1","outcome_safety_issue":null},{"outcome_description":"Blood samples were collected at indicated timepoints for PK analysis.","outcome_measure":"Area under the concentration-time curve from zero to 24h (AUC[0-24]) of VH3739937 on QD dosing.","outcome_time_frame":"Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h post-dose on Day 1","outcome_safety_issue":null},{"outcome_description":"Blood samples were collected at indicated timepoints for PK analysis.","outcome_measure":"Cmax of VH3739937 at steady state (Cmax, ss) on QD dosing","outcome_time_frame":"Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 7","outcome_safety_issue":null},{"outcome_description":"Blood samples were collected at indicated timepoints for PK analysis. Tmax is defined as the time to reach the maximum observed plasma concentration (Cmax).","outcome_measure":"Tmax of VH3739937 at steady state (Tmax, ss) on QD dosing","outcome_time_frame":"Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 7","outcome_safety_issue":null},{"outcome_description":"Blood samples were collected at indicated timepoints for PK analysis.","outcome_measure":"C24 of VH3739937 at steady state (C24, ss) on QD dosing","outcome_time_frame":"At 24h post-dose on Day 7","outcome_safety_issue":null},{"outcome_description":"Blood samples were collected at indicated timepoints for PK analysis.","outcome_measure":"AUC(0-24) of VH3739937 at steady state (AUC[0-24], ss) on QD dosing","outcome_time_frame":"Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h post-dose on Day 7","outcome_safety_issue":null},{"outcome_description":"Blood samples were collected at indicated timepoints for PK analysis.","outcome_measure":"Cmax post single dose of VH3739937","outcome_time_frame":"Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1)","outcome_safety_issue":null},{"outcome_description":"Blood samples were collected at indicated timepoints for PK analysis.","outcome_measure":"Tmax post single dose of VH3739937","outcome_time_frame":"Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1)","outcome_safety_issue":null},{"outcome_description":"C168 is defined as concentration of VH3739937 at a nominal time of 168 hours after dosing. Blood samples were collected at indicated timepoints for PK analysis.","outcome_measure":"Concentration at 168 hours (C168) post single dose of VH3739937","outcome_time_frame":"At 168 hours post-dose (single dose administered on Day 1)","outcome_safety_issue":null},{"outcome_description":"Blood samples were collected at indicated timepoints for analysis.","outcome_measure":"Area under the concentration-time curve from zero to 168h [AUC(0-168)] post single dose of VH3739937","outcome_time_frame":"Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1)","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":[]},"start_date":"12/21/2023 00:00:00","study_type":"Interventional","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":true}},"pageContext":{"studyId":"212580"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}