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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.
"}}}},"site":{"siteMetadata":{"siteUrl":"https://www.viiv-studyregister.com"}},"studyDetails":{"nct_number":"NCT01641809","ctis_id":"","HasResults":"true","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"","IpdInfoTypeCsr":"","IpdInfoTypeProtocol":"","IpdInfoTypeSap":"","IpdTimeFrame":"","IpdUrl":"http://","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"false","masked_caregiver":"false","masked_investigator":"true","masked_subject":"true","masking_description":"","no_masking":"false"},"PatientLevelData":"false","SharingIpd":"","acronym":"","allocation":"Randomized","arm_groups":[{"arm_group_label":"Arm 1 GSK1265744 10 mg","arm_group_description":"In the Induction Phase subjects will receive oral tablets of GSK1265744 10 mg + matching placebo + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 10 mg + matching placebo + Rilpivirine 25 mg once daily from Week 24 to Week 96.","arm_type":"Experimental"},{"arm_group_label":"Arm 2 GSK1265744 30 mg","arm_group_description":"In the Induction Phase subjects will receive oral tablets of GSK1265744 30 mg + matching placebo + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 30 mg + matching placebo + Rilpivirine 25 mg once daily from Week 24 to Week 96.","arm_type":"Experimental"},{"arm_group_label":"Arm 3 GSK1265744 60 mg","arm_group_description":"In the Induction Phase subjects will receive oral tablets of GSK1265744 60 mg + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 60 mg + Rilpivirine 25 mg once daily from Week 24 to Week 96.","arm_type":"Experimental"},{"arm_group_label":"Arm 4 Efavirenz 600 mg","arm_group_description":"In the Induction Phase and Maintenance Phase subjects will receive oral tablets of Efavirenz 600 mg + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine).","arm_type":"Active Comparator"}],"assignment":"Parallel Assignment","brief_summary":"The study is designed to select a dose of GSK1265744 primarily on the basis of antiviral activity and tolerability in HIV-1 infected, antiretroviral naive subjects. This study consists of two parts: Induction Phase: Approximately 200 subjects will be randomized (50 subjects in each of the 4 treatment arms). The Induction Phase consists of a 24 week dose-ranging evaluation of GSK1265744 at blinded doses of 10 mg, 30 mg and 60 mg once-daily and a control arm of open-label efavirenz (EFV) 600 mg once daily. The background dual nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral therapy (ART) for all arms will be either abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) as selected by the Investigator. Subjects randomized to a GSK1265744 containing arm, who successfully complete 24 weeks on study and demonstrate virologic suppression (defined as having a plasma HIV-1 ribonucleic acid [RNA] <50 copies per milliliter [c/mL] before Week 24, with no signs of virologic rebound) will become eligible for the Maintenance Phase of this study. Maintenance Phase: The background NRTIs will be discontinued and the subjects will continue their randomized dose of GSK1265744 in combination with rilpivirine (RPV) 25 mg once-daily for an additional 72 weeks. The Maintenance phase will evaluate the ability of this two drug ART regimen to maintain virologic suppression through Week 48, Week 72 and Week 96. Subjects randomized to the EFV arm will continue on their randomized regimen through Week 96. After completion of the maintenance phase, subjects could enroll in the Open-Label Phase to continue GSK1265744 + RPV treatment as long as they continue to derive clinical benefit and until it is locally approved and commercially available.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Dose ranging study of GSK1265744 plus nucleoside reverse transcriptase inhibitors for induction of human immunodeficiency virus-1 (HIV-1) virologic suppression followed by virologic suppression maintenance by GSK1265744 plus rilpivirine","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:24:00","criteria":"Inclusion Criteria: - HIV-1 infected male or female subjects >= 18 years of age - Screening plasma HIV-1 RNA >=1000 c/mL - CD4+ cell count >=200 cells/millimeter (mm)^3 - ART-naive defined as having =<10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection - Female subjects of child bearing potential are eligible to enter if they are not pregnant and willing to use protocol-specified methods of contraception to prevent pregnancy during the study Exclusion Criteria: - Any evidence at screening of an active Centers for Disease and Prevention Control (CDC) Category C disease - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening - History of ongoing or clinically relevant hepatitis within the previous 6 months, and subjects with moderate to severe hepatic impairment will be excluded - Women who are breastfeeding - Subject, who in the investigator's judgment, poses a significant suicide risk - Any clinically significant finding on screening or baseline electrocardiograph (ECG) - The presence of any specific laboratory abnormalities at Screening - History of cardiac disease - Clinically relevant pancreatitis - Subjects who are unlikely to complete the dosing schedule due to a pre-existing physical or mental condition - Any condition which impairs the absorption, distribution, metabolism or excretion of the investigational product - Any evidence of primary resistance based upon the presence of a major resistance associated mutation in the Screening HIV genotype, or any historical genotype - Treatment with any protocol-specified excluded medication","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 2","display_phase_internal":"PHASE_2","display_status":"Active, not recruiting","display_status_internal":"RECSTATUS_I_ACTIVE_NOT_REC","endpoint":"","enrollment":"244","exclusion":"","gender":"All","gender_based":"","gender_description":"","healthy_volunteers":"No","id":"8358ba3d-632b-5d28-9c64-ec7ff96de1e5","internal":{"content":null,"contentDigest":"d362809a10fbdd8c00a0eb7a54aeebb1","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - HIV-1 infected male or female subjects >= 18 years of age - Screening plasma HIV-1 RNA >=1000 c/mL - CD4+ cell count >=200 cells/millimeter (mm)^3 - ART-naive defined as having =<10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection - Female subjects of child bearing potential are eligible to enter if they are not pregnant and willing to use protocol-specified methods of contraception to prevent pregnancy during the study Exclusion Criteria: - Any evidence at screening of an active Centers for Disease and Prevention Control (CDC) Category C disease - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening - History of ongoing or clinically relevant hepatitis within the previous 6 months, and subjects with moderate to severe hepatic impairment will be excluded - Women who are breastfeeding - Subject, who in the investigator's judgment, poses a significant suicide risk - Any clinically significant finding on screening or baseline electrocardiograph (ECG) - The presence of any specific laboratory abnormalities at Screening - History of cardiac disease - Clinically relevant pancreatitis - Subjects who are unlikely to complete the dosing schedule due to a pre-existing physical or mental condition - Any condition which impairs the absorption, distribution, metabolism or excretion of the investigational product - Any evidence of primary resistance based upon the presence of a major resistance associated mutation in the Screening HIV genotype, or any historical genotype - Treatment with any protocol-specified excluded medication","interventions":[{"arm_group_label":"Arm 1 GSK1265744 10 mg","intervention_description":"GSK1265744 10 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.","intervention_name":"GSK1265744 10 mg","intervention_type":"Drug"},{"arm_group_label":"Arm 2 GSK1265744 30 mg","intervention_description":"GSK1265744 30 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.","intervention_name":"GSK1265744 30 mg","intervention_type":"Drug"},{"arm_group_label":"Arm 3 GSK1265744 60 mg","intervention_description":"GSK1265744 60 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.","intervention_name":"GSK1265744 60 mg","intervention_type":"Drug"},{"arm_group_label":"Arm 4 Efavirenz 600 mg","intervention_description":"Efavirenz 600 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase and Maintenance Phase of the study.","intervention_name":"Efavirenz 600 mg","intervention_type":"Drug"},{"arm_group_label":"Arm 3 GSK1265744 60 mg","intervention_description":"Rilpivirine 25 mg will be administered orally once daily in combination with GSK1265744 10 mg, 30 mg and 60 mg in the Maintenance Phase of the study.","intervention_name":"Rilpivirine 25 mg","intervention_type":"Drug"},{"arm_group_label":"Arm 2 GSK1265744 30 mg","intervention_description":"Rilpivirine 25 mg will be administered orally once daily in combination with GSK1265744 10 mg, 30 mg and 60 mg in the Maintenance Phase of the study.","intervention_name":"Rilpivirine 25 mg","intervention_type":"Drug"},{"arm_group_label":"Arm 1 GSK1265744 10 mg","intervention_description":"Rilpivirine 25 mg will be administered orally once daily in combination with GSK1265744 10 mg, 30 mg and 60 mg in the Maintenance Phase of the study.","intervention_name":"Rilpivirine 25 mg","intervention_type":"Drug"},{"arm_group_label":"Arm 2 GSK1265744 30 mg","intervention_description":"Placebo matching to GSK1265744 will be administered along with GSK1265744 10 mg and 30 mg in the Induction phase and Maintenance phase of the study.","intervention_name":"Placebo","intervention_type":"Drug"},{"arm_group_label":"Arm 1 GSK1265744 10 mg","intervention_description":"Placebo matching to GSK1265744 will be administered along with GSK1265744 10 mg and 30 mg in the Induction phase and Maintenance phase of the study.","intervention_name":"Placebo","intervention_type":"Drug"},{"arm_group_label":"Arm 4 Efavirenz 600 mg","intervention_description":"The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.","intervention_name":"Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)","intervention_type":"Drug"},{"arm_group_label":"Arm 3 GSK1265744 60 mg","intervention_description":"The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.","intervention_name":"Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)","intervention_type":"Drug"},{"arm_group_label":"Arm 2 GSK1265744 30 mg","intervention_description":"The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.","intervention_name":"Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)","intervention_type":"Drug"},{"arm_group_label":"Arm 1 GSK1265744 10 mg","intervention_description":"The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.","intervention_name":"Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":true,"is_high_value":false,"is_ind_study":true,"keywords":["HIV -1","GSK1265744","maintenance phase","dose selection"],"last_follow_up_date":"11/20/2018 00:00:00","links":[],"locations":[{"City":"Valhalla","Latitude":"41.085128","CountryDisplay":"United States","Longitude":"-73.7772032","Name":"GSK Investigational Site","StateDisplay":"New York","PostalCode":"10595","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Buffalo","Latitude":"42.8967674","CountryDisplay":"United States","Longitude":"-78.8863847","Name":"GSK Investigational Site","StateDisplay":"New York","PostalCode":"14201","StatusDisplay":"Recruiting","StatusDisplayInternal":"LOCSTATUS_RECRUITING","StatusMapped":"Recruiting"},{"City":"Montreal","Latitude":"45.50071","CountryDisplay":"Canada","Longitude":"-73.574572","Name":"GSK Investigational 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Site","StateDisplay":"Texas","PostalCode":"75204","StatusDisplay":"Terminated","StatusDisplayInternal":"LOCSTATUS_TERMINATED","StatusMapped":"Terminated/Withdrawn"},{"City":"Macon","Latitude":"32.7918963","CountryDisplay":"United States","Longitude":"-83.6029116","Name":"GSK Investigational Site","StateDisplay":"Georgia","PostalCode":"31201","StatusDisplay":"Recruiting","StatusDisplayInternal":"LOCSTATUS_RECRUITING","StatusMapped":"Recruiting"}],"masking":"","maximum_age_raw":"N/A","maximum_age":"N/A","minimum_age":"18","minimum_age_raw":"18 years","modified_date":"06/18/2024 13:17:24","number_of_arms":"4","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"official_title":"A Phase IIb, dose ranging study of oral GSK1265744 in combination with nucleoside reverse transcriptase inhibitors for induction of human immunodeficiency virus -1 (HIV-1) virologic suppression followed by an evaluation of maintenance of virologic suppression when oral GSK1265744 is combined with oral rilpivirine in HIV-1 infected, antiretroviral therapy naive adult subjects","org_study_id":"116482","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Active, not recruiting - Interventional","oversight_info":{"exported_from_us":"","fda_regulated_device":"","fda_regulated_drug":"","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"2","primary_compl_date":"10/10/2013 00:00:00","primary_outcomes":[{"outcome_description":"Proportion of subjects with HIV-1 RNA <50 copies/mL at Week 48 will be based on Intent-to-Treat Exposed (ITT-E) Population (all randomized subjects who received at least one dose of study drug) using the missing, switch, or discontinuation equals failure (MSDF) algorithm.","outcome_measure":"Proportion of subjects with HIV-1 RNA <50 copies/mL at Week 48","outcome_time_frame":"48 weeks","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"Proportion of subjects with plasma HIV-1 RNA <400 and <50 copies/mL over time by visit will be calculated using the MSDF and observed algorithm.","outcome_measure":"Proportion of subjects with plasma HIV-1 RNA <400 and <50 copies/mL over time by visit","outcome_time_frame":"Through Week 96","outcome_safety_issue":null},{"outcome_description":"Proportion of subjects with HIV-1 RNA <50 copies/mL at Week 16 and Week 24 in Induction Phase will be based on ITT-E Population and MSDF algorithm.","outcome_measure":"Proportion of subjects with HIV-1 RNA <50 copies/mL at Week 16 and Week 24 in Induction Phase","outcome_time_frame":"16 weeks, 24 weeks","outcome_safety_issue":null},{"outcome_description":"The proportion of subjects with HIV-1 RNA <50 copies/mL from Week 24 through Week 96 will be determined by visit for the ITT-ME Population (all randomized subjects who received at least one dose of investigational product [IP] during the Maintenance Phase of the study) using MSDF algorithm.","outcome_measure":"The proportion of subjects with HIV-1 RNA <50 copies/mL from Week 24 through Week 96 by visit in Maintenance Phase","outcome_time_frame":"24 weeks through Week 96","outcome_safety_issue":null},{"outcome_description":"Plasma for quantitative HIV-1 RNA will be collected at every visit from baseline till Follow-up. Methods to determine absolute plasma HIV-1 RNA may include but are not limited to the Abbott RealTime HIV-1 Assay lower limit of detection (LLOD) 40 c/mL. Change from Baseline will be calculated as post-Baseline value minus the Baseline value.","outcome_measure":"Absolute values and change from Baseline in plasma HIV-1 RNA by visit","outcome_time_frame":"Baseline (Study Day 1), and up to Week 96","outcome_safety_issue":null},{"outcome_description":"Disease progression includes HIV-associated conditions, acquired immunodeficiency syndrome (AIDS) and death. HIV-associated conditions will be assessed according to the 1993 Centers for disease control and prevention (CDC) Revised Classification System for HIV Infection in Adults.","outcome_measure":"Incidence of disease progression","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null},{"outcome_description":"Lymphocyte subsets (including CD4+) will be collected for assessment by flow cytometry.","outcome_measure":"Absolute values and changes from baseline in CD4+ cell counts by visit","outcome_time_frame":"Baseline (Study Day 1), and up to Week 96","outcome_safety_issue":null},{"outcome_description":"Development of viral resistance to GSK1265744 and other on-study ART in subjects experiencing virologic failure through Week 24, and viral resistance to GSK1265744 and rilpivirine in subjects experiencing virologic failure from Week 24 through Week 96 will be evaluated. Genotypic and phenotypic analyses may be carried out using, but not limited to, Standard Phenosense and GenoSure testing methods for protease (PRO) and reverse transcriptase (RT), or with GeneSeq Integrase and PhenoSense Integrase assays.","outcome_measure":"Incidence of treatment emergent genotypic and phenotypic resistance to GSK1265744, RPV and other on-study ART for protocol-defined virologic failures","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null},{"outcome_description":"The incidence and severity of AEs and laboratory abnormalities will be determined throughout the study for the Safety Population (all randomized subjects who will be exposed to IP). AEs should be graded according to the Division of AIDS (DAIDS) toxicity scales. AEs and laboratory abnormalities will also be summarized separately for Induction Phase, and Maintenance Phase using the Maintenance Safety Population (all randomized subjects who will be exposed to IP during the Maintenance Phase of the study).","outcome_measure":"Incidence and severity of Adverse Events (AEs) and laboratory abnormalities over time","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null},{"outcome_description":"Monitoring of hematology, blood chemistry and fasting lipids will be done, and changes by visit will be summarized.","outcome_measure":"Absolute values and changes in laboratory parameters by visit","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null},{"outcome_description":"Proportion of subjects who discontinue treatment due to AEs will be determined throughout the study for the Safety Population; subjects who discontinue treatment due to AEs through Week 24 will be also determined in the Induction Phase; and subjects who discontinue treatment due to AEs from Week 24 through Week 96, will be determined using the Maintenance Safety Population.","outcome_measure":"Proportion of subjects who discontinue treatment due to AEs","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null},{"outcome_description":"ECGs will be performed in triplicate at least 5 minutes apart and following 5 minutes of rest in a semi-supine position within 1 hour prior to first dose. Subsequent ECG evaluations during the study should be obtained 2 to 4 hours after GSK1265744 dose.","outcome_measure":"Incidence of any clinically significant changes in QRS duration, QTc interval, HR, PR interval based on electrocardiograph (ECG) readings by visit","outcome_time_frame":"Baseline (Study Day 1), and up to Week 96","outcome_safety_issue":null},{"outcome_description":"The Plasma GSK1265744 PK parameters will be estimated by non-compartmental analysis and/or population PK. The PK data collected in this study will be included in the analysis to investigate the exposure-response relationship and the integrated drug-viral dynamic modeling which will ultimately be used in guiding dose selection.","outcome_measure":"Plasma GSK1265744 pharmacokinetic (PK) parameters [area under the concentration time curve over the dosing interval (AUC[0-tau]), maximum observed concentration (Cmax), and concentration at the end of a dosing interval (Ctau)]","outcome_time_frame":"2 weeks, 12 weeks, 26 weeks, and 36 weeks (Pre-dose and 2 to 4 hours (h) post dose)","outcome_safety_issue":null},{"outcome_description":"The Plasma rilpivirine PK parameters will be estimated by non-compartmental analysis and/or population PK.","outcome_measure":"Plasma rilpivirine PK parameters [AUC(0-tau), Cmax, Ctau]","outcome_time_frame":"2 weeks, 12 weeks, 26 weeks, and 36 weeks (Pre-dose and 2 to 4 hours (h) post dose)","outcome_safety_issue":null},{"outcome_description":"Medication adherence to IP will be based on pill counts by visit.","outcome_measure":"Adherence to IP","outcome_time_frame":"Up to Week 96","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["GSK"]},"start_date":"08/06/2012 00:00:00","study_type":"Interventional","therapeutic_area":"","citations":[],"is_section_801":true}},"pageContext":{"studyId":"116482"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}