EUCTR2015-002712-32-GB进行中（未招募）1 期
A Phase 3b, Randomized, Open-Label Study to Evaluate Switching from a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Subjects Aged = 60 Years
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- •2) Age = 60 years
- •3) Currently receiving a TDF and FTC or 3TC-containing 'backbone' (maximum 2 NRTIs) regimen plus a third agent for = 6 consecutive months prior to screening visit. For subjects with 3 or more ART regimens, a regimen history must be provided for approval by the Sponsor.
- •4) Documented plasma HIV-1 RNA levels < 50 copies/mL for = 6 months preceding the screening visit
- •5) Plasma HIV-1 RNA level < 50 copies/mL at screening visit
- •6) Adequate renal function: Estimated glomerular filtration rate = 30 mL/min according to the Cockcroft-Gault formula
- •(eGFRCG) and are on ARVs that are appropriately dose adjusted for renal function per package insert
- •7) All documented historical plasma genotype(s) must not show resistance to TDF or FTC, including, but not limited to the presence of reverse transcriptase resistance mutations K65R, K70E, M184V/I or thymidine analog-associated mutations (TAMs) that include M41L, L210W, D67N, K70R, T215Y/F, K219Q/E/N/R. If historical plasma genotype prior to first ART is not available or subject has 3 or more ART regimens, subject will have proviral genotype analysis prior to Day 1 to confirm absence of archived resistance to TDF or FTC.
- •8) Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
- •9) Hepatic transaminases (AST and ALT) = 5 × upper limit of normal (ULN)
- •10) Total bilirubin = 1.5 mg/dL and normal direct bilirubin (subjects with documented Gilbert’s syndrome or with atazanavir-associated hyperbilirubinemia may have total bilirubin up to 5 × ULN as long as direct bilirubin is normal)
- •11) Adequate hematologic function
- •- Absolute neutrophil count = 1,000/mm3
- •- Platelets = 50,000/mm3
- •- Hemoglobin = 8.5 g/dL
- •12) Study performed DXA scan and T-score received prior to Day 1
- •13) Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence, and agree to refrain from sperm donation from first dose throughout the study period and for 30 days following the last dose of study drug.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •1) Previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) (for any length of time) if the current regimen contains a PI/r
- •2) Subjects will have no evidence of previous virologic failure on a PI/r or INSTI-based regimen (with or without resistance to either class of ARV).
- •3) A new AIDS-defining condition diagnosed within the 30 days prior to screening (except CD4+ cell count and/or percentage criteria)
- •4) Hepatitis C virus that would require therapy during the study
- •5) Subjects with clinical evidence of decompensated cirrhosis (ascites, encephalopathy, variceal bleeding)
- •6) Women of childbearing potential
- •7) Subjects receiving ongoing treatment for bone disease (eg, osteoporosis), including bisphosphonates, denosumab, and strontium ranelate
- •8) Have an implanted defibrillator or pacemaker
- •9) Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
- •10) 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. Subjects with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 visit and must not be anticipated to require systemic therapy during the study
- •11) Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 Visit
- •12) Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements
- •13) Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial
- •14) Known hypersensitivity to the study drug, the metabolites, or formulation excipients
- •15) Subjects receiving ongoing therapy with any of the medications in Table 4-2 of the protocol, including drugs not to be used due to the potential for interaction with EVG, COBI, FTC, TAF, or 3TC; or subjects with any known allergies to the excipients of E/C/F/TAF FDC tablets.
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