Table 1.

Summary of trial procedures

	Screening visit (−42 days)	Baseline	Week 4* ±2 days	Week 24 ±7 days	Week 48 ±7 days	Week 72 ±7 days	Week 96 ±7 days	Early termination visit
Informed consent	X
Demographic data and medical history, including full ART history and alcohol assessment	X
Randomisation		X
Vital signs	X†	X†	X†	X†	X†	X†	X†	X†
Physical examination, including height, weight and waist circumference	X‡	X‡§		X‡§	X‡§	X‡§	X‡§	X‡§
ECG	X
Urine dip¶ and pregnancy test (for WOCBP)	X	X		X	X	X	X	X
Concomitant medications	X	X	X	X	X	X	X	X
HIV-associated conditions	X	X		X	X	X	X	X
Symptom and AE review	X	X	X	X	X	X	X	X
Diet and exercise history**		X			X		X	X
CLDQ:NAFLD, SF-36 and WPAI:SHP questionnaires		X			X		X	X
ELF score		X			X		X	X
CD4/CD8 T-cell count	X				X		X	X
HIV-1 RNA level	X		X	X	X	X	X	X
Proviral DNA tropism††		X
Haematology‡‡	X	X	X	X	X	X	X	X
Routine chemistry§§	X	X	X	X	X	X	X	X
Fasting chemistry¶¶		X			X		X	X
Additional chemistry***	X				X		X	X
HIV, HBV and HCV serology†††	X
Full liver screen‡‡‡	X
Ultrasound liver§§§	X
Fibroscan¶¶¶	X				X		X	X
CT liver:spleen attenuation ratio****		X					X
Drug dispensation††††		X	X	X	X	X

*Week 4 visit only for individuals receiving MVC. Blood is unfasted.

†Heart rate, respiratory rate, temperature, BP, lying and standing BP (postural BP at screening only and to be repeated if history indicates).

‡Height only at screening; weight and waist circumference at every visit except week 4.

§Symptom directed physical examination only.

¶Point of care urine dip for haematuria, proteinuria, glycosuria, leucocytes and nitrites.

**Dietary history will be daily intake of olive oil, fruit, vegetables or salad, legumes, fish, wine, meat, white bread, rice and whole-grain bread.²⁹ Exercise history will be the number of times per week exercise is undertaken, number of minutes of exercise per episode and type of exercise.

††If no result within the preceding 24 weeks.

‡‡Haemoglobin, white cell count and differential, eosinophils and platelets.

§§Sodium, potassium, chloride, creatinine, urea, alanine aminotransferase, aspartate aminotransferase, bilirubin, alkaline phosphatase, gamma glutamyltransferase, albumin, phosphate, creatine kinase, glucose (screening, weeks 4, 24 and 72), lipids (total cholesterol, HDL, LDL and TGs) (weeks 24 and 72 only).

¶¶Fasting glucose and fasting lipids (total cholesterol, HDL, LDL, TGs).

***Haemoglobin A1c.

†††HCV antibody, HCV RNA or HCV antigen, HBsAg; if no prior record of result: HBcAb. HIV antibody-antigen only if no previous documented result.

‡‡‡If no previous record of result: INR, ferritin, caeruloplasmin, copper, thyroid function, alpha-1 antitrypsin, antimitochondrial antibodies, antinuclear antibodies, antismooth muscle antibody, antiliver/kidney/microsomal antibodies-1 and coeliac serology.

§§§If no previous imaging (ultrasound, CT or MRI) result confirming fatty liver in the preceding 24 weeks.

¶¶¶Includes both median stiffness and controlled attenuation parameter scores, to be performed within 7 days of the study visit.

****Optional. To be performed within 7 days of the study visit. Preference is for the 7 days prior to baseline.

††††Only for individuals assigned to the MVC group.

AE, adverse event; ART, antiretroviral therapy; BP, blood pressure; CK, creatine kinase; CLDQ:NAFLD, chronic liver disease questionnaire for non-alcoholic fatty liver disease; ELF, enhanced liver fibrosis; HBsAb, hepatitis B core antibody; HBsAg, hepatitis B surface antigen; HDL, high-density lipoprotein; INR, international normalised ratio; LDL, low-density lipoprotein; MVC, maraviroc; SF-36, 36-Item Short Form Survey; TG, triglycerides; US, ultrasound; WOCBP, women of childbearing potential; WPAI:SHP, Work Productivity and Activity Impairment: Specific Health Problem Questionnaire.