If you entered a web address please check it was correct.
\nYou can also try Search Page to find the study you are looking for.
"}}},"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.
"}}}},"site":{"siteMetadata":{"siteUrl":"https://www.viiv-studyregister.com"}},"studyDetails":{"nct_number":"","ctis_id":"","HasResults":"false","IpdAccessCriteria":"Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.","IpdDescription":"IPD for this study will be made available via the Clinical Study Data Request site.","IpdInfoTypeAnalyticCode":"false","IpdInfoTypeIcf":"true","IpdInfoTypeCsr":"true","IpdInfoTypeProtocol":"true","IpdInfoTypeSap":"true","IpdTimeFrame":"IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.","IpdUrl":"http://clinicalstudydatarequest.com","IsFlexibleTrial":false,"IsReleasedToCtGov":"false","MaskingInfo":{"masked_assessor":"false","masked_caregiver":"false","masked_investigator":"false","masked_subject":"false","masking_description":"","no_masking":"true"},"PatientLevelData":"false","SharingIpd":"Yes","acronym":"","allocation":"Non-randomized","arm_groups":[{"arm_group_label":"Subject receiving Dolutegravir 10 mg","arm_group_description":"Subject will receive a prototype equivalent to DTG 10 mg liquid formulation in period 1, a prototype equivalent to DTG 10 mg liquid formulation in period 2, a DTG 10 mg dispersible tablet in Period 3, each period will be separated by washout period of >= 7 days, if required a prototype equivalent to DTG 10 mg liquid formulation in period 4, a prototype equivalent to DTG 10 mg liquid formulation in period 5, and a prototype equivalent to DTG 10 mg liquid formulation in period 6 will be evaluated.","arm_type":"Experimental"}],"assignment":"Sequential Assignment","brief_summary":"This is an open-label, single-center, single dose, non-randomized, sequential, fixed-sequence study, which will evaluate pharmacokinetics (PK) of dolutegravir (DTG) in healthy adult subjects. The study will contain 6 periods with five prototype liquid formulations for evaluation in fasted state. In period 1, 2 and 3 single reference dose of 2 dispersible tablets of 5 milligram DTG will be administered and at least 2 liquid prototype DTG formulations (containing a target total dose of 10mg DTG). There will be a wash-out period of 7 days between each period. In period 4 through 6, there would be options to evaluate additional prototype liquid formulations. The total duration of study will be up to 17 weeks. DTG has been found to be safe and effective in adults infected with human immunodeficiency virus (HIV), and DTG liquid formulation are being developed for the treatment of HIV-infected pediatric subjects who weigh less than 25 kilograms (Kgs). Approximately 18 subjects will be enrolled in this study.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Dolutegravir pediatric liquid formulation study","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"HIV infections","LookupValue_OneLinkTx":""}],"created_date":"03/16/2019 07:40:08","criteria":"Inclusion Criteria: \n - Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent. \n - Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac evaluation.\n - Body weight >= 50 kg (110 pounds [lbs]) for men and >=45 kg (99 lbs) for women and body mass index (BMI) within the range 18.5-31.0 kilogram per meter square (kg/m^2) (inclusive).\n - Male and female subjects will be part of study. A female subject is eligible to participate if she is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP).\n - Additional requirements for pregnancy testing, if needed, during and after study intervention; The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n - Subject should be capable of giving signed informed consent as which includes compliance with the requirements and restrictions listed in the informed consent form (ICF). \n\nExclusion Criteria:\n - History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.\n - Abnormal blood pressure as determined by the investigator.\n - Alanine transaminase (ALT) >1.5 times upper limit of normal (ULN).\n - Bilirubin >1.5times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).\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 - QT correction using Fridericia Formula (QTcF) >450 millisecond (msec)\n - Past or intended use of over-the-counter or prescription medication (including herbal medications) within 7 days prior to dosing. Paracetamol.\n - History of allergy or sensitivity to DTG.\n - Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.\n - Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.\n - Current enrollment or past participation within the last 30 days before signing of consent in this or any other clinical study involving an investigational study intervention or any other type of medical research.\n - Presence of Hepatitis B surface antigen (HBsAg), or a positive hepatitis B core antibody with a negative hepatitis B surface antibody at screening.\n - Positive Hepatitis C antibody test result at screening: Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C ribonucleic acid (RNA) test is obtained.\n - Positive Hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.\n - Positive pre-study drug/alcohol screen.\n - Positive HIV antibody test.\n - Regular use of known drugs of abuse.\n - Regular alcohol consumption within one month prior to the study defined as: For the United Kingdom an average weekly intake of >14 units for males or females. One unit is equivalent to 8 gram (g) of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.\n - Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g. nicotine patches or vaporizing devices) within 6 months prior to screening.","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 1","display_phase_internal":"PHASE_1","display_status":"Not yet recruiting","display_status_internal":"RECSTATUS_I_NOT_YET_REC","endpoint":"","enrollment":"18","exclusion":"","gender":"All","gender_based":"No","gender_description":"","healthy_volunteers":"Yes","id":"007cced7-0bd6-55e9-b9c0-df85808f80bb","internal":{"content":null,"contentDigest":"d87cbd6d290d625c2692e6ee1bff52a2","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: \n - Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent. \n - Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac evaluation.\n - Body weight >= 50 kg (110 pounds [lbs]) for men and >=45 kg (99 lbs) for women and body mass index (BMI) within the range 18.5-31.0 kilogram per meter square (kg/m^2) (inclusive).\n - Male and female subjects will be part of study. A female subject is eligible to participate if she is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP).\n - Additional requirements for pregnancy testing, if needed, during and after study intervention; The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n - Subject should be capable of giving signed informed consent as which includes compliance with the requirements and restrictions listed in the informed consent form (ICF). \n\nExclusion Criteria:\n - History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.\n - Abnormal blood pressure as determined by the investigator.\n - Alanine transaminase (ALT) >1.5 times upper limit of normal (ULN).\n - Bilirubin >1.5times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).\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 - QT correction using Fridericia Formula (QTcF) >450 millisecond (msec)\n - Past or intended use of over-the-counter or prescription medication (including herbal medications) within 7 days prior to dosing. Paracetamol.\n - History of allergy or sensitivity to DTG.\n - Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.\n - Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.\n - Current enrollment or past participation within the last 30 days before signing of consent in this or any other clinical study involving an investigational study intervention or any other type of medical research.\n - Presence of Hepatitis B surface antigen (HBsAg), or a positive hepatitis B core antibody with a negative hepatitis B surface antibody at screening.\n - Positive Hepatitis C antibody test result at screening: Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C ribonucleic acid (RNA) test is obtained.\n - Positive Hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.\n - Positive pre-study drug/alcohol screen.\n - Positive HIV antibody test.\n - Regular use of known drugs of abuse.\n - Regular alcohol consumption within one month prior to the study defined as: For the United Kingdom an average weekly intake of >14 units for males or females. One unit is equivalent to 8 gram (g) of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.\n - Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g. nicotine patches or vaporizing devices) within 6 months prior to screening.","interventions":[{"arm_group_label":"Subject receiving Dolutegravir 10 mg","intervention_description":"DTG will be available as an oral tablet with dosing strength of 5 mg 2 tablet will be dispersed in water will be administered orally for prescribed regimen.","intervention_name":"Dolutegravir dispersible tablet","intervention_type":"Drug"},{"arm_group_label":"Subject receiving Dolutegravir 10 mg","intervention_description":"DTG will be available as an oral suspension with dosing strength of 5 mg per milliliter (ml) or 2 mg per ml with miglyol 812N or ethyl cellulose in miglyol 812N as vehicle for suspension administered orally for prescribed regimen.","intervention_name":"Dolutegravir oral suspension","intervention_type":"Drug"},{"arm_group_label":"Subject receiving Dolutegravir 10 mg","intervention_description":"DTG will be available as an oral solution with dosing strength of 2 mg per ml will be administered orally for prescribed regimen.","intervention_name":"Dolutegravir oral solution","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":true,"is_high_value":false,"is_ind_study":false,"keywords":["Dolutegravir","Human immunodeficiency virus","Sequential study","Dispersible tablet","Suspension","Liquid solution"],"last_follow_up_date":"06/07/2019 00:00:00","links":[],"locations":[{"City":"Nottingham","Latitude":"52.8789746","CountryDisplay":"United Kingdom","Longitude":"-1.1841629","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"NG11 6","StatusDisplay":"Not yet recruiting","StatusDisplayInternal":"LOCSTATUS_NOT_YET_REC","StatusMapped":"Will Be Recruiting"}],"masking":"","maximum_age_raw":"55 Years","maximum_age":"55","minimum_age":"18","minimum_age_raw":"18 Years","modified_date":"03/16/2019 07:40:08","number_of_arms":"1","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"official_title":"Non-randomized, sequential, fixed-sequence evaluation of prototype dolutegravir liquid formulations versus 5mg dolutegravir dispersible tablets following single-dose fasted-state administrations to normal healthy adult participants","org_study_id":"209354","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Not yet recruiting - Interventional","oversight_info":{"exported_from_us":"Yes","fda_regulated_device":"No","fda_regulated_drug":"Yes","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"Phase 1","primary_compl_date":"06/07/2019 00:00:00","primary_outcomes":[{"outcome_description":"Blood samples will be collected for pharmacokinetic analysis of DTG","outcome_measure":"Area under the plasma concentration time curve from time zero to the last quantifiable time point (AUC[0-t]) following administration of DTG","outcome_time_frame":"Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected for pharmacokinetic analysis of DTG","outcome_measure":"AUC from time zero to infinity (0-inf) following administration of DTG","outcome_time_frame":"Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected for pharmacokinetic analysis of DTG","outcome_measure":"Maximum observed concentration (Cmax) following administration of DTG","outcome_time_frame":"Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose","outcome_safety_issue":null}],"product_name":"dolutegravir","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"Blood samples will be collected for pharmacokinetic analysis of DTG","outcome_measure":"Absorption lag time (tlag) following administration of DTG","outcome_time_frame":"Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected for pharmacokinetic analysis of DTG","outcome_measure":"Time of maximum observed concentration (tmax) following administration of DTG","outcome_time_frame":"Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected for pharmacokinetic analysis of DTG","outcome_measure":"Time of last quantifiable concentration (t) following administration of DTG","outcome_time_frame":"Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected for pharmacokinetic analysis of DTG","outcome_measure":"Elimination half-life (t½) following administration of DTG","outcome_time_frame":"Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected for pharmacokinetic analysis of DTG","outcome_measure":"Apparent elimination rate constant (lambda z) following administration of DTG","outcome_time_frame":"Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected for pharmacokinetic analysis of DTG","outcome_measure":"Percentage of AUC(0-inf) extrapolated (%AUCex) following administration of DTG","outcome_time_frame":"Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected for pharmacokinetic analysis of DTG","outcome_measure":"AUC from time zero to 24 hours (AUC[0-24]) following administration of DTG","outcome_time_frame":"Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected for pharmacokinetic analysis of DTG","outcome_measure":"AUC from time zero to 72 hours (AUC[0-72]) following administration of DTG","outcome_time_frame":"Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected for pharmacokinetic analysis of Dolutegravir","outcome_measure":"Apparent oral clearance (CL/F) following administration of Dolutegravir","outcome_time_frame":"Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected for pharmacokinetic analysis of Dolutegravir","outcome_measure":"Apparent oral volume of distribution (Vz/F) following administration of Dolutegravir","outcome_time_frame":"Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected for pharmacokinetic analysis of Dolutegravir","outcome_measure":"Last quantifiable concentration (Ct) following administration of Dolutegravir","outcome_time_frame":"Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected for pharmacokinetic analysis of Dolutegravir","outcome_measure":"Concentration at 24h post-dose (C24) following administration of Dolutegravir","outcome_time_frame":"Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose","outcome_safety_issue":null},{"outcome_description":"Systolic and diastolic blood pressure of subjects will be measured in a supine position after at least 5 minutes of rest with a completely automated device.","outcome_measure":"Change from Baseline in blood pressure","outcome_time_frame":"Baseline and Up to Week 10","outcome_safety_issue":null},{"outcome_description":"Heart rate of subjects will be measured in a supine position after at least 5 minutes of rest.","outcome_measure":"Change from Baseline in heart rate","outcome_time_frame":"Baseline and Up to Week 10","outcome_safety_issue":null},{"outcome_description":"An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Any untoward medical occurrence resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as serious adverse event.","outcome_measure":"Number of subjects with adverse events and serious adverse events","outcome_time_frame":"Up to Week 10","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected from subjects for the analysis of hematology parameters as a measure of safety, including platelet count, red blood cell, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, percent reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils, and basophils.","outcome_measure":"Number of subjects with toxicity grading for hematology parameters","outcome_time_frame":"Up to Week 10","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected from subjects for the analysis of clinical chemistry parameters as a measure of safety, including blood urea nitrogen, potassium, aspartate aminotransferase, total bilirubin, indirect bilirubin, direct bilirubin, albumin, creatinine, sodium, alanine aminotransferase, total protein, glucose (fasted), calcium, alkaline phosphatase, and creatine kinase.","outcome_measure":"Number of subjects with toxicity grading for clinical chemistry parameters","outcome_time_frame":"Up to Week 10","outcome_safety_issue":null},{"outcome_description":"Urine samples will be collected from subjects for the analysis of urinalysis parameters as a measure of safety, including specific gravity and potential of hydrogen (pH) of urine, presence of glucose, protein, blood, and ketones in urine by dipstick test. Microscopic examination will be performed if blood or protein is abnormal.","outcome_measure":"Number of subjects with toxicity grading for urine parameters","outcome_time_frame":"Up to Week 10","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["NA"]},"start_date":"04/22/2019 00:00:00","study_type":"Interventional","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":false}},"pageContext":{"studyId":"209354"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}