A phase IV, open-label pilot study investigating non-invasive markers of hepatic fibrosis in people living with HIV-1 and non-alcoholic fatty liver disease randomised to receiving optimised background therapy (OBT) plus maraviroc or OBT - HEPMARC Study

Brighton and Sussex University Hospitals NHS Trus0 个研究点目标入组 60 人开始时间: 2018年5月22日最近更新: 2018年5月28日

适应症

试验速览

暂无简介。

•Inclusion criteria
•(1)Aged 18 years and older
•(2)HIV-1 infected with durably suppressed (= 6 months) HIV VL
•NB. One HIV VL blip is allowed in the 6 months prior to screen.
•(3)Has had = 6 months prior exposure to maraviroc
•(4)Has evidence of NAFLD on hepatic imaging (USS, CT or MRI) either at screen or in the 6 months prior to screen
•(5)Provides written, informed consent to participate
•(6)Is willing to comply with the protocol requirements
•(7)If female and of child bearing potential, is using effective birth control methods (as agreed by the investigator) and willing to continue practising these birth control measures during the trial and for at least 30 days after the end of the trial.
•Note: Women who are postmenopausal for least 2 years, women with a total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential
•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 57
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

•Exclusion criteria
•(1)Severe cardiovascular disease including known angina or history of myocardial infarction
•(2)History of postural hypotension, defined as a reduction in the systolic blood pressure of = 20mmHg after standing for at least one minute
•(3)Individuals already receiving MVC at screening
•(4)HIV viral load detectable (one blip within 6 months prior to screen is allowed)
•(5)Current HCV or HBV (HBcAb-positive, HBsAg-negative is permitted; anti-HCV Ab positive with HCV RNA negative for = 12 months following treatment or spontaneous clearance is permitted)
•(6)Other chronic liver disease including but not exclusively: cirrhosis, alcohol-related liver disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, haemochromatosis, Wilson’s disease, alpha-1 antitrypsin deficiency, non-cirrhotic portal hypertension, drug-induced as deemed by a hepatologist
•(7)ALT or AST > 3x the ULN (where ULN is defined locally as 41 IU/L)
•(8)Severe renal insufficiency (creatinine clearance < 30 mL/min)
•(10) HIV-2 infection
•(11) Known allergy or intolerance to MVC or its constituents including hypersensitivity to peanuts or soya
•(12) If female, pregnancy or breastfeeding

发起方

Brighton and Sussex University Hospitals NHS Trus