EUCTR2017-003428-61-ES进行中（未招募）1 期
A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching from an Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Regimen or a Tenofovir Disoproxil Fumarate Containing Regimen to Fixed-Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Elderly, Virologically-Suppressed, HIV-1 Infected Subjects Aged = 65 Years
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 86
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
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
- •1) The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- •2) Age = 65 years
- •3) Currently receiving an ARV regimen of E/C/F/TAF FDC (or FTC/TDF + 3rd agent if currently or previously participated in GS-US-292-1826) for = 3 months
- •4) Documented plasma HIV-1 RNA < 50 copies/mL during treatment with E/C/F/TAF (or FTC/TDF + 3rd agent if currently or previously participated in GS-US-292-1826) for the last 2 visits preceding the Screening Visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is = 50 copies/mL)
- •a) Unconfirmed virologic elevations of = 50 copies/mL but < 400 copies/mL (transient detectable viremia, or blip”) in the past are acceptable.
- •b) If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests after < 50 copies/mL has been achieved.
- •5) Plasma HIV-1 RNA levels < 50 copies/mL at Screening Visit
- •6) Have no documented or suspected resistance to FTC, TFV, or BIC including, but not limited, to the reverse transcriptase resistance mutations K65R and M184V/I
- •7) Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
- •8) Adequate renal function: eGFR = 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
- •9) Male subjects who are fertile and engage in heterosexual intercourse with women who are of child-bearing potential must agree to use protocol specified method(s) of contraception
- •10) Male subjects must agree to refrain from sperm donation from first study drug dose until after the end of relevant systemic exposure
- •11) Life expectancy >1 year
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- •1) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
- •2) Subjects experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
- •3) Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids (e.g. prednisone doses > 10 mg daily or equivalent) during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
- •4) Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
- •5) Malignancy within 5 years of screening other than cutaneous Kaposi’s sarcoma, completely resected non-melanoma skin cancer (basal cell carcinoma or non-invasive cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix (CIN 3) or anus
- •(AIN 3). A prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least five years prior to screening is allowed.
- •6) Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
- •7) Participation in any other clinical trial, including observational studies, without prior approval from the Medical Monitor
- •8) 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 the dosing requirements
- •9) Known hypersensitivity to B/F/TAF FDC tablets, their metabolites, or formulation excipient
- •10) Subjects receiving ongoing therapy with any of the medications listed in the protocol, including drugs not to be used with BIC, FTC, and TAF
- •11) Acute hepatitis in the 30 days prior to study entry
- •12) Active tuberculosis infection
研究者
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