EUCTR2018-004732-30-GB进行中（未招募）1 期
A Phase IV, Randomised, Open-Label Pilot Study to Evaluate Switching from Protease-Inhibitor based regimen to Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in Integrase Inhibitor-naïve, virologically suppressed HIV-1 infected adults harbouring drug resistance mutations. - PIBIK Study
niversity of Sussex0 个研究点目标入组 100 人开始时间: 2019年5月9日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •18 years and above
- •Any nadir CD4 count and baseline VL
- •On a bPI-based ART regimen with at least one documented HIV-1 RNA <50 copies/mL within the previous 6 months and at screening
- •Eligible drug resistance mutations in historical genotype include the following:
- •oM184V/I with or without any nucleoside analogue mutation (e.g. L74I/V, Y115F, K70E/G/Q/T/N/S)
- •oM184V/I alone
- •oUp to 2 TAMs (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R) with or without M184V/I
- •oAny of the above with or without NNRTI mutations
- •No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI)
- •No known INSTI mutations
- •Must have historical genotype
- •Estimated GFR = 50 mL/min (Cockcroft-Gault formula)
- •Have the following laboratory values at screening within 30 days prior to baseline
- •a) Alkaline phosphatase = 3.0 x upper limit of normal (ULN)
- •b) AST and ALT = 5.0 x ULN
- •c) Hemoglobin =9.0 g/dL (if female) or =10.0 g/dL (if male).
- •Provides written, informed consent to participate
- •Is willing to comply with the protocol requirements
- •If female and of child bearing potential, is using effective birth control methods (as agreed by the investigator) and willing to continue practicing these birth control measures during the trial and for at least 30 days after the end of the trial.
- •If male, and sexually-active with female partners of child bearing potential, is using effective barrier contraception, and willing to continue using this during the trial and for at least 30 days after the end of the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Exclusion under drug resistance mutations include:
- •oPresence of any of the following mutations: K65R/N/E
- •oPresence of multidrug resistance mutations: T69ins, Q151M with or without A62V, V75I, F77L, F116Y
- •othree or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, or K219Q/E/N/R)
- •Individuals experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding)
- •An opportunistic illness within the 30 days prior to screening
- •Active tuberculosis infection
- •Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine based therapies)
- •Current alcohol or substance use judged by the Investigator to potentially interfere with subjects’ adherence to study procedure.
- •A history of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study
- •Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 (except if the parenteral therapy is for syphilis infection)
- •Any other clinical condition or prior therapy that will, in the opinion of the investigator, make the subject ineligible
- •Any known allergies to the excipients of B/F/TAF FDC
- •Females who are pregnant (as confirmed by positive urine pregnancy test)
- •Females who are breastfeeding
- •Women of child bearing age not using any reliable form of contraception (e.g. intrauterine device/intrauterine system, long-acting contraceptive injection, in addition to barrier methods)
- •Acute hepatitis in the 30 days prior to study entry, anyone with HCV who is likely to need direct acting antivirals in study
- •Any concomitant medications that cannot be administered with TAF (i.e strong inducers of p-glycoprotein) or bictegravir (dofetilide, rifampins)
研究者
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