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and HIV Service","Manchester",{"type":59,"coordinates":946},[947,948],-2.23743,53.48095,{"lat":948,"lon":947},{"type":951,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100235620","phase-3-switch-study-to-evaluate-the-safety-and-efficacy-of-emtricitabinerilpivirinetenofovir-alafenamide-ftcrpvtaf-fixed-dose-combination-fdc-in-hiv-1-positive-adults-who-are-virologically-suppressed-on-emtricitabinerilpivirinetenofovir-disoproxil-fumarate-ftcrpvtdf-100235620",true,"NCT02345252","Switch Study to Evaluate the Safety and Efficacy of Emtricitabine\u002FRilpivirine\u002FTenofovir Alafenamide (FTC\u002FRPV\u002FTAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine\u002FRilpivirine\u002FTenofovir Disoproxil Fumarate (FTC\u002FRPV\u002FTDF)","A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of 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After reaching HIV-1 RNA \\\u003C 50 copies\u002FmL, single values of HIV-1 RNA ≥ 50 copies\u002FmL followed by resuppression, are allowed\n* Have no documented resistance to any of the study agents at any time in the past\n* HIV-1 RNA \\\u003C 50 copies\u002FmL at the screening visit\n* Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 mg\u002FdL (≤ 26 μmol\u002FL), or normal direct bilirubin\n* Adequate hematologic function (absolute neutrophil count ≥ 1,000\u002Fmm\\^3 (1.00 GI\u002FL); platelets ≥ 50,000\u002Fmm\\^3 (50 GI\u002FL); hemoglobin ≥ 8.5 g\u002FdL (85 g\u002FL))\n* Serum amylase ≤ 5 × ULN (individuals with serum amylase \\> 5 × ULN will remain eligible if serum lipase is ≤ 5 × ULN)\n* Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)\n* Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL\u002Fmin (1.17 mL\u002Fsec) according to the Cockcroft-Gault formula\n\nKey Exclusion Criteria:\n\n* Hepatitis B surface antigen (HBsAg) positive\n* Hepatitis C antibody positive with detectable hepatitis C virus (HCV) RNA (individuals who have HCV antibody but no detectable HCV RNA are eligible to enroll)\n* Individuals experiencing or with a medical history of decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)\n* Females who are breastfeeding\n* Positive serum pregnancy test\n* Current alcohol or substance use judged by the Investigator to potentially interfere with individual's study compliance\n* A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline\u002FDay 1 and must not be anticipated to require systemic therapy during the study\n* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline\u002FDay 1\n* Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements\n* Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial\n* Individuals receiving ongoing therapy with any of the disallowed medications listed in the protocol, including drugs not to be used with FTC, RPV and\u002For TAF; or individuals with any known allergies to the excipients of FTC\u002FRPV\u002FTAF\n\nNote: Other Inclusion\u002FExclusion criteria may apply.",false,"ALL","18 Years",{"count":963,"type":964},632,"ACTUAL","INTERVENTIONAL",[967],"PHASE3","The primary objective of this study is to evaluate the noninferiority of switching to emtricitabine\u002Frilpivirine \u002Ftenofovir alafenamide (FTC\u002FRPV\u002FTAF) fixed-dose combination (FDC) as compared to continuing FTC\u002FRPV\u002Ftenofovir disoproxil fumarate (TDF) FDC (FTC\u002FRPV\u002FTDF) in virologically suppressed HIV-1 infected participants.",[970],"HIV-1 Infection",[972],"HIV","COMPLETED","2019-12-16",{"date":976,"type":964},"2020-01-02",{"date":978,"type":964},"2015-01-26",{"date":980,"type":964},"2019-01-09",{"name":5,"class":6},117]