{"componentChunkName":"component---src-templates-study-details-page-js","path":"/en/study/HPR10006","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":"NCT00257621","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":"","arm_groups":[],"assignment":"Single Group Assignment","brief_summary":"This is a proof of concept (POC) single arm study of GW640385, a protease inhibitor, in combination with RTV and 2 or more nucleoside reverse transcriptase inhibitors (NRTI) backbone. This study has a 48 week duration and is open to both treatment naive and experienced patients who are HIV positive. There are 3 intensive pharmacokinetic (PK) visits.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus I","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:39:23","criteria":"Inclusion criteria: - HIV-1 infected subjects. - Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception. - Plasma HIV-1 RNA (viral load) >/=1,000 copies/mL at Screening. - CD4+ cell count >/= 200 cells/mm3 at Screening. - Be able to receive at least two of the following NRTIs (3TC, FTC, d4T, ddI or ZDV)to build a nucleoside backbone regimen. - Willing and able to provide signed and dated written informed consent prior to study entry. Exclusion criteria: - Active CDC Class C disease. - Pregnant or breastfeeding women. - Protocol-specified laboratory abnormalities at Screening. - Personal or family history of autoimmune disease. - History or current indication of thyroid dysfunction or current thyroid gland abnormalities.","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 2","display_phase_internal":"PHASE_2","display_status":"Completed","display_status_internal":"RECSTATUS_I_COMPLETED","endpoint":"","enrollment":"30","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"No","id":"c43a41bb-4fb0-5d42-97ac-61a14f377092","internal":{"content":null,"contentDigest":"4e0734de21b526f44fcbba5ebc3aefdd","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion criteria: - HIV-1 infected subjects. - Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception. - Plasma HIV-1 RNA (viral load) >/=1,000 copies/mL at Screening. - CD4+ cell count >/= 200 cells/mm3 at Screening. - Be able to receive at least two of the following NRTIs (3TC, FTC, d4T, ddI or ZDV)to build a nucleoside backbone regimen. - Willing and able to provide signed and dated written informed consent prior to study entry. Exclusion criteria: - Active CDC Class C disease. - Pregnant or breastfeeding women. - Protocol-specified laboratory abnormalities at Screening. - Personal or family history of autoimmune disease. - History or current indication of thyroid dysfunction or current thyroid gland abnormalities.","interventions":[{"arm_group_label":"","intervention_description":"","intervention_name":"GW640385","intervention_type":"Drug"},{"arm_group_label":"","intervention_description":"","intervention_name":"Ritonavir","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":null,"is_high_value":false,"is_ind_study":true,"keywords":["HIV-1 protease inhibitor GW640385 ritonavir RTV"],"last_follow_up_date":"01/01/2007 00:00:00","links":[],"locations":[{"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":"Washington","Latitude":"38.9191485","CountryDisplay":"United States","Longitude":"-77.0362967","Name":"GSK Investigational Site","StateDisplay":"District of Columbia","PostalCode":"20009","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"},{"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":"San Francisco","Latitude":"37.7877522","CountryDisplay":"United States","Longitude":"-122.4382307","Name":"GSK Investigational Site","StateDisplay":"California","PostalCode":"94115","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":"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":"Seattle","Latitude":"47.6015566","CountryDisplay":"United States","Longitude":"-122.3323351","Name":"GSK Investigational Site","StateDisplay":"Washington","PostalCode":"98104","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"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"}],"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 23:06:06","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 pilot, phase II, open-label, single arm study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of GW640385 when administered with ritonavir in combination with NRTIs for 48 weeks in HIV-1 infected adults","org_study_id":"HPR10006","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"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":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"2","primary_compl_date":"01/01/2007 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Percentage of subjects with plasma HIV-1 RNA <400 copies/ml. Incidence of serious adverse events, rash and thyroid function abnormalities. GW640385 PK parameters.","outcome_time_frame":"throughout the study","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"Changes over time in HIV-1 viral load and CD4+ cell counts. Incidence of adverse events and laboratory abnormalities. GW640385 and RTV PK parameters. Development of resistance in subjects with virologic failure.","outcome_time_frame":"throughout the study","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"None","lead_sponsor":"ViiV Healthcare","collaborators":[]},"start_date":"10/01/2004 00:00:00","study_type":"Interventional","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":null}},"pageContext":{"studyId":"HPR10006"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}