{"componentChunkName":"component---src-templates-study-details-page-js","path":"/en/study/A4001075","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":"NCT00717067","ctis_id":"","HasResults":"true","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"","IpdInfoTypeCsr":"","IpdInfoTypeProtocol":"","IpdInfoTypeSap":"","IpdTimeFrame":"","IpdUrl":"","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"","masked_caregiver":"","masked_investigator":"","masked_subject":"","masking_description":"","no_masking":""},"PatientLevelData":"false","SharingIpd":"","acronym":"","allocation":"Nonrandomized Trial","arm_groups":[{"arm_group_label":"Healthy Subjects","arm_group_description":"Subjects with Normal Renal Function (Creatinine Clearance > 80mL/min) (I) Maraviroc single dose, followed by (II) Maraviroc + Saquinavir/Ritonavir","arm_type":"Experimental"},{"arm_group_label":"Mild Renal Impairment","arm_group_description":"Subjects with Mild Renal Impairment (Creatinine Clearance >50 and ≤80 mL/min)","arm_type":"Experimental"},{"arm_group_label":"Moderate Renal Impairment","arm_group_description":"Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min)","arm_type":"Experimental"},{"arm_group_label":"Severe Renal Impairment","arm_group_description":"Subjects with Severe Renal Impairment (Creatinine Clearance <30 mL/min)","arm_type":"Experimental"},{"arm_group_label":"ESRD on Hemodialysis","arm_group_description":"Subjects with End Stage Renal Impairment receiving Hemodialysis(Creatinine Clearance <30 mL/min) (I) Maraviroc single dose one hour following completion of hemodialysis, followed by (II) Maraviroc single dose three hours prior to start of hemodialysis","arm_type":"Experimental"}],"assignment":"Parallel","brief_summary":"The purpose of this study is to assess whether a dosing adjustment is needed in patients with renal impairment.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Human Immunodeficiency Virus (HIV) Infection","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 18:06:36","criteria":"Inclusion Criteria: - Stable Renal Function defined as ≤20% (25% for normal renal function) difference between 2 measurements of serum creatinine obtained on 2 occasions separated by at least 2 weeks. - Body Mass Index (BMI) of approximately 18 to 40 kg/m2 inclusive. - Total body weight >50 kg (110 lbs). - Male or female subjects between the ages of 18 and 85 years. Exclusion Criteria: - Subjects with acute renal disease and/or history of renal transplant. - Supine BP at Screening ≥160 mm Hg systolic or ≥95 mm Hg diastolic. - Supine BP at Screening ≤80 mm Hg systolic or ≤40 mm Hg diastolic.","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 4","display_phase_internal":"PHASE_4","display_status":"Completed","display_status_internal":"RECSTATUS_I_COMPLETED","endpoint":"","enrollment":"30","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"Yes","id":"7bf7d16f-2624-56fa-9224-1c2aa932bd84","internal":{"content":null,"contentDigest":"da996ca1b9fbdc682d08c7b0d6091944","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - Stable Renal Function defined as ≤20% (25% for normal renal function) difference between 2 measurements of serum creatinine obtained on 2 occasions separated by at least 2 weeks. - Body Mass Index (BMI) of approximately 18 to 40 kg/m2 inclusive. - Total body weight >50 kg (110 lbs). - Male or female subjects between the ages of 18 and 85 years. Exclusion Criteria: - Subjects with acute renal disease and/or history of renal transplant. - Supine BP at Screening ≥160 mm Hg systolic or ≥95 mm Hg diastolic. - Supine BP at Screening ≤80 mm Hg systolic or ≤40 mm Hg diastolic.","interventions":[{"arm_group_label":"Healthy Subjects","intervention_description":"Maraviroc 300 mg (150 mg x 2 tablets) x single dose","intervention_name":"Maraviroc","intervention_type":"Drug"},{"arm_group_label":"Healthy Subjects","intervention_description":"Maraviroc 150 mg tablet twice daily x 7 days","intervention_name":"Maraviroc","intervention_type":"Drug"},{"arm_group_label":"Healthy Subjects","intervention_description":"Ritonavir 100 mg capsule twice daily x 7 days","intervention_name":"Ritonavir","intervention_type":"Drug"},{"arm_group_label":"Healthy Subjects","intervention_description":"Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days","intervention_name":"Saquinavir","intervention_type":"Drug"},{"arm_group_label":"Mild Renal Impairment","intervention_description":"Maraviroc 150 mg tablet once daily x 7 days","intervention_name":"Maraviroc","intervention_type":"Drug"},{"arm_group_label":"Mild Renal Impairment","intervention_description":"Ritonavir 100 mg capsule twice daily x 7 days","intervention_name":"Ritonavir","intervention_type":"Drug"},{"arm_group_label":"Mild Renal Impairment","intervention_description":"Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days","intervention_name":"Saquinavir","intervention_type":"Drug"},{"arm_group_label":"Moderate Renal Impairment","intervention_description":"Maraviroc 150 mg tablet once every 48 hours x 7 days","intervention_name":"Maraviroc","intervention_type":"Drug"},{"arm_group_label":"Moderate Renal Impairment","intervention_description":"Ritonavir 100 mg capsule twice daily x 7 days","intervention_name":"Ritonavir","intervention_type":"Drug"},{"arm_group_label":"Moderate Renal Impairment","intervention_description":"Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days","intervention_name":"Saquinavir","intervention_type":"Drug"},{"arm_group_label":"Severe Renal Impairment","intervention_description":"Maraviroc 300 mg (150 mg x 2 tablets) x single dose","intervention_name":"Maraviroc","intervention_type":"Drug"},{"arm_group_label":"ESRD on Hemodialysis","intervention_description":"Maraviroc 300 mg (150 mg x 2 tablets) x single dose one hour following completion of hemodialysis","intervention_name":"Maraviroc","intervention_type":"Drug"},{"arm_group_label":"ESRD on Hemodialysis","intervention_description":"Maraviroc 300 mg (150 mg x 2 tablets) x single dose three hours prior to start of hemodialysis","intervention_name":"Maraviroc","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":true,"is_high_value":false,"is_ind_study":true,"keywords":["maraviroc, pharmacokinetics, renal impairment"],"last_follow_up_date":"11/01/2008 00:00:00","links":[{"description":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001075&StudyName=Pharmacokinetics%2C%20Safety%20And%20Toleration%20Of%0AMaraviroc%20Administered%20To%20Subjects%20With%20Various%20Degrees%20Of%20Renal%20Impaired%20And%20Normal%20Renal%20Fu"},{"description":"Link to ClinicalStudyResults.org","url":"http://www.clinicalstudyresults.org/drugdetails/?study_name=A4001075&sort=c.company_name&page=1&drug_id=9824"}],"locations":[{"City":"Muenchen","Latitude":"48.1408957","CountryDisplay":"Germany","Longitude":"11.4645399","Name":"Pfizer Investigational Site","StateDisplay":null,"PostalCode":"81241","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Berlin","Latitude":"52.5155098","CountryDisplay":"Germany","Longitude":"13.3847539","Name":"Pfizer Investigational Site","StateDisplay":null,"PostalCode":"10117","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"}],"masking":"Open","maximum_age_raw":"85 Years","maximum_age":"85","minimum_age":"18","minimum_age_raw":"18 Years","modified_date":"10/01/2018 22:54:49","number_of_arms":"5","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, Parallel Group, Single And Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function","org_study_id":"A4001075","overall_contact":{"email":null,"last_name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021"},"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":"PHASE 4","primary_compl_date":"11/01/2008 00:00:00","primary_outcomes":[],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":null,"outcome_measure":null,"outcome_time_frame":null,"outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["Pfizer"]},"start_date":"07/01/2008 00:00:00","study_type":"Interventional","therapeutic_area":"","citations":[],"is_section_801":false}},"pageContext":{"studyId":"A4001075"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}