A study in which people who have HIV and fatty liver disease, who do not drink excessive alcohol, are either asked to take the drug maraviroc on top of their normal anti-HIV medicines or to take their normal anti-HIV medicines alone

Phase 1

• Conditions: on-alcoholic fatty liver disease in people living with well-controlled HIV-1 infection; MedDRA version: 20.1Level: PTClassification code 10029530Term: Non-alcoholic fatty liverSystem Organ Class: 10019805 - Hepatobiliary disorders; MedDRA version: 20.1Level: LLTClassification code 10008919Term: Chronic HIV infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-004141-24-GB
• Lead Sponsor: Brighton and Sussex University Hospitals NHS Trus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-22
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified