EUCTR2013-002780-26-Outside-EU/EEA进行中（未招募）1 期
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 InfectedAntiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- •12 years to < 18 years of age at Baseline
- •Weight = 35 kg (77 lbs) at screening
- •Plasma HIV-1 RNA levels of >= 1,000 copies/mL at Screening (Roche COBAS TaqMan v2.0)
- •Screening genotype report shows sensitivity to EVG, FTC and TFV
- •No prior use of any approved or experimental anti-HIV-1 drug for any length of time (other than that given for prevention of mother-to-child transmission)
- •6 to < 12 years of age at Baseline
- •Weight = 25 kg (55 lbs) at Screening
- •Plasma HIV-1 RNA: < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of dectection is > 50 copies/mL) for = 180 consecutive days (6 months) prior to Screening on a stable antiretroviral regimen, without documented history of resistance to any component of E/C/F/TAF STR
- •Both Cohorts
- •CD4+ cell count > 100 cells/µL
- •Adequate renal function: Estimated glomerular filtration rate = 90 mL/min/1.73m2
- •Clinically normal ECG (or if abnormal, determined by the investigator to be not clinically significant)
- •Documented screening for active pulmonary tuberculosis per local standard of care within 6 months of a Screening visit.
- •Hepatic transaminases (AST and ALT) = 5 x upper limit of normal (ULN)
- •Total bilirubin = 1.5 mg/dL, or normal direct bilirubin
- •Adequate hematologic function (absolute neutrophil count = 500/mm3; platelets = 50,000/mm3; hemoglobin = 8.5 g/dL)
- •Negative serum pregnancy test for all female subjects
- •Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from Screening throughout the duration of study treatment and for 30 days following discontinuation of investigational medicinal product. Pre-pubertal females (Tanner Stages 1 and 2 are not considered to be of childbearing potential, unless onset of menarche has occurred).
- •Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to Baseline.
- •Male subjects must agree to utilize highly effective contraception methods during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from Baseline throughout the study period and for 30 days following discontinuation of investigational medicinal product.
- •Able to swallow oral tablets
- •Must be willing and able to comply with all study requirements
- •Life expectancy > 1 year
- •Subjects able to give written assent prior to any screening evaluations
- •Parent or guardian able to give written informed consent prior to any screening evaluations and willing to comply with study requirements
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A new AIDS-defining condition diagnosed within the 30 days prior to Screening
- •Positive Hepatitis C antibody
- •Positive Hepatitis B surface antigen or other evidence of active HBV infection.
- •Prior treatment with any approved or investigational or experimental anti HIV-1 drug for any length of time (other than that given for prevention of mother-to-child transmission)
- •Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the Screening visit.
- •Anticipated to require rifamycin treatment for mycobacterial infection while participating
- •in the study. Note: prophylactic INH therapy for latent TB treatment is allowed.
- •Subjects experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
- •Pregnant or lactating subjects
- •Have an implanted defibrillator or pacemaker
- •Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include uncontrolled renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous,
- •gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment within 30 days prior to the study dosing.
- •Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance.
- •Have history of significant drug sensitivity or drug allergy.
- •Known hypersensitivity to the study drugs, the metabolites or formulation excipients
- •Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study Screening or expected to receive these agents during the study (e.g., immunoglobulins, and other immune- or cytokine-based therapies).
- •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 Baseline and must not be 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 Baseline.
- •Have previously participated in an investigational trial involving administration of any investigational agent within 30 days prior to the study dosing.
- •Participation in any other clinical trial (including observational trials) without prior approval from sponsor is prohibited while participating in this trial.
- •Subjects receiving ongoing therapy with any of the medications specified in protocol section 4.3, including drugs not to be used with EVG, COBI, FTC, TDF and TAF (For FTC refer to the individual agents Prescribing Information; for EVG, COBI, and TAF refer to the E/C/F/TAF STR Investigator Brochure); or subjects with any known allergies to the excipients of E/C/F/TAF STR tablets.
研究者
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