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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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CBV-TP will be measured in specific blood cells. The amount of ABC and CBV-TP will be looked at when subjects receive ABC as a 300mg dose twice a day and compared with the levels when they receive ABC as a 600mg dose once a day.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Comparison of Abacavir Following Once-Daily And Twice-Daily Administration In HIV Infected Subjects","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"HIV Infection","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 18:03:34","criteria":"Inclusion criteria: - Healthy adults , inclusively. - Documented HIV-1 infection (documented by historical data or current validated assay). - Undetectable viral load. - Currently on an ABC-tablet containing regimen for at least 8 weeks. - Willingness to temporarily switch ABC schedule from BID to QD, or vice versa, for 11 days. - Weigh between 40-100kg, inclusive. Exclusion criteria: - Subjects who are receiving tenofovir. - Previous study participation in other experimental drug trial(s) within 30 days before the screening phase of the study. - Subjects who currently regularly take drugs-of-abuse, with the exception of cannabinoids. - Subjects who cannot refrain from taking herbal remedies during the course of the study. - Subjects who regularly consume more than an average amount of alcohol per day. - Poor general health preventing fasting or blood sampling. - Subjects who are not able to discontinue use of hydroxyurea, mycophenolate or ribavirin for 14 days prior to entering the study until discharge from the study. - An unwillingness of a male subject to abstain from sexual intercourse with women of childbearing potential or an unwillingness to use a condom in addition to having their female partner use another form of contraception. - The subject is pregnant or nursing an infant. - History of symptoms consistent with a hypersensitivity reaction to ABC. - Positive HCV Antibody or HepBsAg (Hepatitis B surface antigen).","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 1","display_phase_internal":"PHASE_1","display_status":"Completed","display_status_internal":"RECSTATUS_I_COMPLETED","endpoint":"","enrollment":"30","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"yes","id":"e3529180-d6f1-5a70-ac70-156e3daba4d3","internal":{"content":null,"contentDigest":"300dcf8dde7fbf78a6e9940c10ec2029","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion criteria: - Healthy adults , inclusively. - Documented HIV-1 infection (documented by historical data or current validated assay). - Undetectable viral load. - Currently on an ABC-tablet containing regimen for at least 8 weeks. - Willingness to temporarily switch ABC schedule from BID to QD, or vice versa, for 11 days. - Weigh between 40-100kg, inclusive. Exclusion criteria: - Subjects who are receiving tenofovir. - Previous study participation in other experimental drug trial(s) within 30 days before the screening phase of the study. - Subjects who currently regularly take drugs-of-abuse, with the exception of cannabinoids. - Subjects who cannot refrain from taking herbal remedies during the course of the study. - Subjects who regularly consume more than an average amount of alcohol per day. - Poor general health preventing fasting or blood sampling. - Subjects who are not able to discontinue use of hydroxyurea, mycophenolate or ribavirin for 14 days prior to entering the study until discharge from the study. - An unwillingness of a male subject to abstain from sexual intercourse with women of childbearing potential or an unwillingness to use a condom in addition to having their female partner use another form of contraception. - The subject is pregnant or nursing an infant. - History of symptoms consistent with a hypersensitivity reaction to ABC. - Positive HCV Antibody or HepBsAg (Hepatitis B surface antigen).","interventions":[{"arm_group_label":"","intervention_description":"","intervention_name":"abacavir","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":null,"is_high_value":false,"is_ind_study":true,"keywords":["Human Immunodeficiency Virus","HIV","Abacavir regime","ABC"],"last_follow_up_date":null,"links":[],"locations":[{"City":"London","Latitude":"51.4847527","CountryDisplay":"United Kingdom","Longitude":"-0.1836283","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"SW10 9TH","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"}],"masking":"Open Label","maximum_age_raw":"65 Years","maximum_age":"65","minimum_age":"18","minimum_age_raw":"18 Years","modified_date":"10/01/2018 23:00:41","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":"An open-label, two-period, crossover, pharmacokinetic study of abacavir and its intracellular anabolite carbovir triphosphate following once-daily and twice-daily administration of abacavir in HIV-infected subjects.","org_study_id":"CAL102120","overall_contact":{"email":null,"last_name":"US GSK Clinical Trials Call Center","phone":"877-379-3718"},"overall_status":"Completed - Interventional","oversight_info":{"exported_from_us":"","fda_regulated_device":"","fda_regulated_drug":"","ped_postmarket_surv":"","has_dmc":null,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"Phase 1","primary_compl_date":null,"primary_outcomes":[{"outcome_description":"","outcome_measure":"To assess the pharmacokinetics of intracellular CBV-TP at steady state following administration of 600 mg QD and 300 mg BID ABC-containing regimens in HIV infected adult subjects.","outcome_time_frame":"throughout the study","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"- To compare plasma concentrations of ABC, and intracellular CBV-TP - To assess the safety and tolerability of dosing with ABC 300mg BID and 600mg QD. - To assess potential gender effects in the pharmacokinetics of ABC.","outcome_time_frame":"throughout the study","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":[]},"start_date":"09/01/2005 00:00:00","study_type":"interventional","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":null}},"pageContext":{"studyId":"CAL102120"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}