{"componentChunkName":"component---src-templates-study-details-page-js","path":"/en/study/100136","result":{"data":{"studyNotFoundJson":{"title":"Study not found","content":{"childMarkdownRemark":{"html":"<p>If you entered a web address please check it was correct.</p>\n<p>You can also try <a href=\"/en/studies\">Search Page</a> to find the study you are looking for.</p>"}}},"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":"<p>A unique number for a study given by ViiV.</p>"}},"ctGov":{"childMarkdownRemark":{"html":"<p>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.</p>"}},"eudraCT":{"childMarkdownRemark":{"html":"<p>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.</p>"}}}},"site":{"siteMetadata":{"siteUrl":"https://www.viiv-studyregister.com"}},"studyDetails":{"nct_number":"NCT00102778","ctis_id":"","HasResults":"false","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"","IpdInfoTypeCsr":"","IpdInfoTypeProtocol":"","IpdInfoTypeSap":"","IpdTimeFrame":"","IpdUrl":"","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"false","masked_caregiver":"false","masked_investigator":"false","masked_subject":"false","masking_description":"","no_masking":""},"PatientLevelData":"false","SharingIpd":"","acronym":"","allocation":"Randomized","arm_groups":[],"assignment":"Parallel Assignment","brief_summary":"This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Kaletra in HIV infected, untreated subjects.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"GW873140 In Combination With Kaletra In HIV Infected Subjects","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus I","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:40:11","criteria":"Inclusion criteria: - HIV infected, therapy-naive subjects. - Females must be of either non-childbearing age, or have a negative pregnancy test. - All subjects participating in this study should be counseled on the practice of safe sex using a proven double barrier method of contraception throughout the study. - Screening lab result of plasma HIV-1 RNA greater than or equal to 50,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3. - Have CC Chemokine Receptor5-tropic (R5-tropic) or CC Chemokine Receptor5/CXC Chemokine Receptor4-tropic (R5/X4-tropic) virus based on viral tropism test at screening visit. - Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or an nucleoside reverse transcriptase inhibitor/nucleotide reverse transcriptase inhibitor (NRTI/ NtRTI), or less than or equal to 7 days of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI). - Prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor (experimental or approved) is not allowed. - Be able to understand and follow with protocol requirements, instructions and protocol-stated restrictions. - Signed and dated written informed consent prior to study entry. Exclusion criteria: - No detection of CXC Receptor4-tropic (X4-tropic) virus only, based on viral tropism test at screening. - No active Class C AIDS-defining illness. - No laboratory abnormalities at screen. - No significant blood loss prior to study start. - No pregnant or breastfeeding women. - Additional qualifying criteria to be determined by the physician.","detailed_description":"A Phase IIb, 96 week, randomized, open-label, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of different doses and regimens of GW873140 in combination with Kaletra (lopinavir and ritonavir) in HIV-1 infected antiretroviral therapy naive subjects","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 2","display_phase_internal":"PHASE_2","display_status":"Other","display_status_internal":"RECSTATUS_OTHER","endpoint":"","enrollment":"175","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"No","id":"30c55a25-74f9-5d60-9e4f-03e3854cfe3e","internal":{"content":null,"contentDigest":"4a6486d756b3c167d95d86e626208427","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion criteria: - HIV infected, therapy-naive subjects. - Females must be of either non-childbearing age, or have a negative pregnancy test. - All subjects participating in this study should be counseled on the practice of safe sex using a proven double barrier method of contraception throughout the study. - Screening lab result of plasma HIV-1 RNA greater than or equal to 50,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3. - Have CC Chemokine Receptor5-tropic (R5-tropic) or CC Chemokine Receptor5/CXC Chemokine Receptor4-tropic (R5/X4-tropic) virus based on viral tropism test at screening visit. - Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or an nucleoside reverse transcriptase inhibitor/nucleotide reverse transcriptase inhibitor (NRTI/ NtRTI), or less than or equal to 7 days of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI). - Prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor (experimental or approved) is not allowed. - Be able to understand and follow with protocol requirements, instructions and protocol-stated restrictions. - Signed and dated written informed consent prior to study entry. Exclusion criteria: - No detection of CXC Receptor4-tropic (X4-tropic) virus only, based on viral tropism test at screening. - No active Class C AIDS-defining illness. - No laboratory abnormalities at screen. - No significant blood loss prior to study start. - No pregnant or breastfeeding women. - Additional qualifying criteria to be determined by the physician.","interventions":[{"arm_group_label":"","intervention_description":"","intervention_name":"GW873140","intervention_type":"Drug"},{"arm_group_label":"","intervention_description":"","intervention_name":"Kaletra (lopinavir/ritonavir)","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":null,"is_high_value":false,"is_ind_study":true,"keywords":["HIV infected","therapy-naive subjects"],"last_follow_up_date":"09/01/2007 00:00:00","links":[],"locations":[{"City":"West Palm Beach","Latitude":"26.8404331","CountryDisplay":"United States","Longitude":"-80.0590804","Name":"GSK Investigational Site","StateDisplay":"Florida","PostalCode":"33408","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Tampa","Latitude":"28.0133862","CountryDisplay":"United States","Longitude":"-82.5077593","Name":"GSK Investigational Site","StateDisplay":"Florida","PostalCode":"33614","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Los Angeles","Latitude":"34.1220545","CountryDisplay":"United States","Longitude":"-118.2935891","Name":"GSK Investigational Site","StateDisplay":"California","PostalCode":"90027","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Washington","Latitude":"38.9080786","CountryDisplay":"United States","Longitude":"-77.0406147","Name":"GSK Investigational Site","StateDisplay":"District of Columbia","PostalCode":"20036","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Milano","Latitude":"45.5145841","CountryDisplay":"Italy","Longitude":"9.1358629","Name":"GSK Investigational Site","StateDisplay":"Lombardia","PostalCode":"20157","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Tucson","Latitude":"32.2625656","CountryDisplay":"United States","Longitude":"-111.1175767","Name":"GSK Investigational Site","StateDisplay":"Arizona","PostalCode":"85745","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Le Kremlin Bicêtre Cedex","Latitude":"48.810108","CountryDisplay":"France","Longitude":"2.356972","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"94275","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Brighton","Latitude":"50.8187517","CountryDisplay":"United Kingdom","Longitude":"-0.1201139","Name":"GSK Investigational Site","StateDisplay":"Sussex East","PostalCode":"BN2 1ES","StatusDisplay":"Terminated","StatusDisplayInternal":"LOCSTATUS_TERMINATED","StatusMapped":"Terminated/Withdrawn"},{"City":"Atlanta","Latitude":"33.8676889","CountryDisplay":"United States","Longitude":"-84.4645184","Name":"GSK Investigational Site","StateDisplay":"Georgia","PostalCode":"30339","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Sevilla","Latitude":"37.3552204","CountryDisplay":"Spain","Longitude":"-5.9673967","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"41013","StatusDisplay":"Terminated","StatusDisplayInternal":"LOCSTATUS_TERMINATED","StatusMapped":"Terminated/Withdrawn"},{"City":"Orlando","Latitude":"28.5747416","CountryDisplay":"United States","Longitude":"-81.3949264","Name":"GSK Investigational Site","StateDisplay":"Florida","PostalCode":"32804","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Sainte-Foy","Latitude":"46.7691394","CountryDisplay":"Canada","Longitude":"-71.2832751","Name":"GSK Investigational Site","StateDisplay":"Québec","PostalCode":"G1V 4G2","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Atlanta","Latitude":"33.7717008","CountryDisplay":"United States","Longitude":"-84.3726049","Name":"GSK Investigational Site","StateDisplay":"Georgia","PostalCode":"30308","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Torino","Latitude":"45.0963655","CountryDisplay":"Italy","Longitude":"7.6636292","Name":"GSK Investigational Site","StateDisplay":"Piemonte","PostalCode":"10149","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Chicago","Latitude":"41.9403795","CountryDisplay":"United States","Longitude":"-87.6531805","Name":"GSK Investigational Site","StateDisplay":"Illinois","PostalCode":"60657","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Koebenhavn","Latitude":"55.7085326","CountryDisplay":"Denmark","Longitude":"12.5727765","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"DK-2100","StatusDisplay":"Terminated","StatusDisplayInternal":"LOCSTATUS_TERMINATED","StatusMapped":"Terminated/Withdrawn"},{"City":"San Francisco","Latitude":"37.7877522","CountryDisplay":"United States","Longitude":"-122.4382307","Name":"GSK Investigational Site","StateDisplay":"California","PostalCode":"94115-1931","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Vancouver","Latitude":"49.278915","CountryDisplay":"Canada","Longitude":"-123.12909","Name":"GSK Investigational Site","StateDisplay":"British Columbia","PostalCode":"V6Z 2C7","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Villejuif Cedex","Latitude":"48.792716","CountryDisplay":"France","Longitude":"2.359279","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"94804","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Saint Denis Cedex 01","Latitude":"48.936181","CountryDisplay":"France","Longitude":"2.357443","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"93205","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"New York","Latitude":"40.7366138","CountryDisplay":"United States","Longitude":"-74.0094471","Name":"GSK Investigational Site","StateDisplay":"New York","PostalCode":"10014","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"New Orleans","Latitude":"29.9510658","CountryDisplay":"United States","Longitude":"-90.0715323","Name":"GSK Investigational Site","StateDisplay":"Louisiana","PostalCode":"70127-0800","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Washington","Latitude":"38.9156487","CountryDisplay":"United States","Longitude":"-77.0737149","Name":"GSK Investigational Site","StateDisplay":"District of Columbia","PostalCode":"20007","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"London","Latitude":"51.5073509","CountryDisplay":"United Kingdom","Longitude":"-0.1277583","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"EC1 7BE","StatusDisplay":"Terminated","StatusDisplayInternal":"LOCSTATUS_TERMINATED","StatusMapped":"Terminated/Withdrawn"},{"City":"Los Angeles","Latitude":"34.0931603","CountryDisplay":"United States","Longitude":"-118.3783347","Name":"GSK Investigational Site","StateDisplay":"California","PostalCode":"90069","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Portland","Latitude":"45.5266975","CountryDisplay":"United States","Longitude":"-122.6880503","Name":"GSK Investigational Site","StateDisplay":"Oregon","PostalCode":"97209","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Toronto","Latitude":"43.6584136","CountryDisplay":"Canada","Longitude":"-79.3891419","Name":"GSK Investigational Site","StateDisplay":"Ontario","PostalCode":"M5G 2N2","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Hamburg","Latitude":"53.5580847","CountryDisplay":"Germany","Longitude":"10.011979","Name":"GSK Investigational Site","StateDisplay":"Hamburg","PostalCode":"20099","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Milano","Latitude":"45.5000627","CountryDisplay":"Italy","Longitude":"9.2273552","Name":"GSK Investigational Site","StateDisplay":"Lombardia","PostalCode":"20127","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Tourcoing","Latitude":"50.7316919","CountryDisplay":"France","Longitude":"3.1353531","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"59208","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Paris Cedex 13","Latitude":"48.856614","CountryDisplay":"France","Longitude":"2.3522219","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"75651","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"New Orleans","Latitude":"29.9219677","CountryDisplay":"United States","Longitude":"-90.1073935","Name":"GSK Investigational Site","StateDisplay":"Louisiana","PostalCode":"70115","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Paris Cedex 10","Latitude":"48.856614","CountryDisplay":"France","Longitude":"2.3522219","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"75475","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Charlotte","Latitude":"35.1811188","CountryDisplay":"United States","Longitude":"-80.8488498","Name":"GSK Investigational Site","StateDisplay":"North Carolina","PostalCode":"28209","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Marseille","Latitude":"43.2916612","CountryDisplay":"France","Longitude":"5.3965729","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"13005","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Lisboa","Latitude":"38.7222524","CountryDisplay":"Portugal","Longitude":"-9.1393366","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"1150","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"AMSTERDAM","Latitude":"52.3471776","CountryDisplay":"Netherlands","Longitude":"4.8240178","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"1066 EC","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Jackson","Latitude":"32.3163028","CountryDisplay":"United States","Longitude":"-90.1729106","Name":"GSK Investigational Site","StateDisplay":"Mississippi","PostalCode":"39202","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Denver","Latitude":"39.7316982","CountryDisplay":"United States","Longitude":"-104.9213643","Name":"GSK Investigational Site","StateDisplay":"Colorado","PostalCode":"80220","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Madrid","Latitude":"40.4998271","CountryDisplay":"Spain","Longitude":"-3.6876803","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"28034","StatusDisplay":"Terminated","StatusDisplayInternal":"LOCSTATUS_TERMINATED","StatusMapped":"Terminated/Withdrawn"},{"City":"Santa Fe","Latitude":"35.616067","CountryDisplay":"United States","Longitude":"-105.8525154","Name":"GSK Investigational Site","StateDisplay":"New Mexico","PostalCode":"87505","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Hamburg","Latitude":"53.5688101","CountryDisplay":"Germany","Longitude":"9.9819779","Name":"GSK Investigational Site","StateDisplay":"Hamburg","PostalCode":"20146","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Paris Cedex 20","Latitude":"48.8575475","CountryDisplay":"France","Longitude":"2.3513765","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"75970","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Berlin","Latitude":"52.5411171","CountryDisplay":"Germany","Longitude":"13.3509304","Name":"GSK Investigational Site","StateDisplay":"Berlin","PostalCode":"13353","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Fort Lauderdale","Latitude":"26.1640451","CountryDisplay":"United States","Longitude":"-80.1121493","Name":"GSK Investigational Site","StateDisplay":"Florida","PostalCode":"33306","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Cascais","Latitude":"38.7144586","CountryDisplay":"Portugal","Longitude":"-9.4505993","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"2750","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Fort Myers","Latitude":"26.6235485","CountryDisplay":"United States","Longitude":"-81.8770671","Name":"GSK Investigational Site","StateDisplay":"Florida","PostalCode":"33901","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Nantes","Latitude":"47.196147","CountryDisplay":"France","Longitude":"-1.537269","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"44093","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Paris Cedex 14","Latitude":"48.8314408","CountryDisplay":"France","Longitude":"2.3255684","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"75679","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Hvidovre","Latitude":"55.6240369","CountryDisplay":"Denmark","Longitude":"12.4771974","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"DK-2650","StatusDisplay":"Terminated","StatusDisplayInternal":"LOCSTATUS_TERMINATED","StatusMapped":"Terminated/Withdrawn"},{"City":"Ottawa","Latitude":"45.4007277","CountryDisplay":"Canada","Longitude":"-75.6492669","Name":"GSK Investigational Site","StateDisplay":"Ontario","PostalCode":"K1H 8L6","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Paris Cedex 12","Latitude":"48.8575475","CountryDisplay":"France","Longitude":"2.3513765","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"75571","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Birmingham","Latitude":"52.4366501","CountryDisplay":"United Kingdom","Longitude":"-1.9375135","Name":"GSK Investigational Site","StateDisplay":"Warwickshire","PostalCode":"B29 6JD","StatusDisplay":"Terminated","StatusDisplayInternal":"LOCSTATUS_TERMINATED","StatusMapped":"Terminated/Withdrawn"},{"City":"Hamilton","Latitude":"43.2573546","CountryDisplay":"Canada","Longitude":"-79.892506","Name":"GSK Investigational Site","StateDisplay":"Ontario","PostalCode":"L8N 3Z5","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Houston","Latitude":"29.740582","CountryDisplay":"United States","Longitude":"-95.4515725","Name":"GSK Investigational Site","StateDisplay":"Texas","PostalCode":"77027","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Bonn","Latitude":"50.6980735","CountryDisplay":"Germany","Longitude":"7.0871788","Name":"GSK Investigational Site","StateDisplay":"Nordrhein-Westfalen","PostalCode":"53127","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Philadelphia","Latitude":"39.9556241","CountryDisplay":"United States","Longitude":"-75.1647529","Name":"GSK Investigational Site","StateDisplay":"Pennsylvania","PostalCode":"19102","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Long Beach","Latitude":"33.7844997","CountryDisplay":"United States","Longitude":"-118.1971031","Name":"GSK Investigational Site","StateDisplay":"California","PostalCode":"90813","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Koeln","Latitude":"50.9096296","CountryDisplay":"Germany","Longitude":"6.9137713","Name":"GSK Investigational Site","StateDisplay":"Nordrhein-Westfalen","PostalCode":"50937","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Allentown","Latitude":"40.5719198","CountryDisplay":"United States","Longitude":"-75.4927278","Name":"GSK Investigational Site","StateDisplay":"Pennsylvania","PostalCode":"18103","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"London","Latitude":"51.5531762","CountryDisplay":"United Kingdom","Longitude":"-0.1652792","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"NW3 2QG","StatusDisplay":"Terminated","StatusDisplayInternal":"LOCSTATUS_TERMINATED","StatusMapped":"Terminated/Withdrawn"},{"City":"Bradenton","Latitude":"27.4872771","CountryDisplay":"United States","Longitude":"-82.5889012","Name":"GSK Investigational Site","StateDisplay":"Florida","PostalCode":"34205","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Frankfurt","Latitude":"50.1109221","CountryDisplay":"Germany","Longitude":"8.6821267","Name":"GSK Investigational Site","StateDisplay":"Hessen","PostalCode":"60590","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Manchester","Latitude":"53.5191895","CountryDisplay":"United Kingdom","Longitude":"-2.2276047","Name":"GSK Investigational Site","StateDisplay":"Lancashire","PostalCode":"M8 5RB","StatusDisplay":"Terminated","StatusDisplayInternal":"LOCSTATUS_TERMINATED","StatusMapped":"Terminated/Withdrawn"},{"City":"Fountain Valley","Latitude":"33.7168761","CountryDisplay":"United States","Longitude":"-117.9600466","Name":"GSK Investigational Site","StateDisplay":"California","PostalCode":"92708","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Phoenix","Latitude":"33.4636012","CountryDisplay":"United States","Longitude":"-112.0535987","Name":"GSK Investigational Site","StateDisplay":"Arizona","PostalCode":"85006","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Chicago","Latitude":"41.9577761","CountryDisplay":"United States","Longitude":"-87.6556468","Name":"GSK Investigational Site","StateDisplay":"Illinois","PostalCode":"60613","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Paris","Latitude":"48.891305","CountryDisplay":"France","Longitude":"2.3529867","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"75018","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Fort Lauderdale","Latitude":"26.1897731","CountryDisplay":"United States","Longitude":"-80.1037721","Name":"GSK Investigational Site","StateDisplay":"Florida","PostalCode":"33308","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Hampton","Latitude":"37.0538822","CountryDisplay":"United States","Longitude":"-76.3984537","Name":"GSK Investigational Site","StateDisplay":"Virginia","PostalCode":"23666","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"}],"masking":"Open Label","maximum_age_raw":"N/A N/A","maximum_age":"N/A","minimum_age":"18","minimum_age_raw":"18 years","modified_date":"10/01/2018 22:16:06","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":"A Phase IIb, 96 week, randomized, open-label multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, PK and antiviral effect of different doses and regimens of GW873140 in combination with Kaletra (lopinavir and ritonavir) in HIV-1 infected antiretroviral therapy naïve subjects","org_study_id":"100136","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Terminated","oversight_info":{"exported_from_us":"","fda_regulated_device":"","fda_regulated_drug":"","ped_postmarket_surv":"","has_dmc":null,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"2","primary_compl_date":"09/01/2007 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"To select a GW873140 dose and dosage regimen for further evaluation based on comparison of the short-term antiviral activity, safety and tolerability of different oral doses of GW873140 in combination with LPV/r in HIV-1 infected therapy-naive subjects.","outcome_time_frame":"","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"HIV-1 RNA decay rate Long-term safety Effects on plasma viral tropismViral resistance to GW873140 and other on-study drugsPK parameters of GW873140 in subjects receiving combination therapy.","outcome_time_frame":"","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"None","lead_sponsor":"ViiV Healthcare","collaborators":[]},"start_date":"12/01/2004 00:00:00","study_type":"Interventional","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":null}},"pageContext":{"studyId":"100136"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}