Amiodarone
P-glycoprotein (P-gp) inducers (e.g., rifampin, St. John's wort)
Liver biopsy at any time showing mHAI stage 4 or higher fibrosis OR
FibroScan within 12 months demonstrating liver stiffness of =9.5 kilo Pascal or
AST to platelet ratio index (APRI) =2.0 and Fibrosis-4 (FIB-4) =3.25
NOTE: If APRI and FIB-4 are discordant one of the other forms of fibrosis staging must be used.
Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
Hemochromatosis
Alpha-1 antitrypsin deficiency
Wilson's disease
Autoimmune hepatitis
Alcoholic liver disease
Drug-related liver disease
Severe NC confounding conditions (stroke, head injury, or developmental learning disability).
Regular use of anti-inflammatory drugs.
Current or recent treatment with pegylated interferon (PEG-IFN).
Other active inflammatory process (major infection, malignancy, rheumatoid arthritis/autoimmune disorder) within the prior 28 days.
Contraindications to magnetic resonance imaging (MRI).
Bleeding diathesis, thrombocytopenia, or use of anticoagulants that would contraindicate lumbar puncture.
Uncontrolled or active depression or other psychiatric disorder that in the opinion of the site investigator might preclude adherence to study requirements or impact NC functioning and assessments.
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Presence of active or acute AIDS-defining opportunistic infections within 12 weeks prior to study entry.

NCT02650024_exc_T1
Drug
Amiodarone
NCT02650024_exc_T2
Drug
P-glycoprotein (P-gp) inducers
NCT02650024_exc_T3
Drug
rifampin
NCT02650024_exc_T4
Drug
St. John's wort
NCT02650024_exc_T5
Scope
rifampin, St. John's wort
NCT02650024_exc_T6
Procedure
Liver biopsy
NCT02650024_exc_T7
Measurement
mHAI stage
NCT02650024_exc_T8
Value
4 or higher
NCT02650024_exc_T9
Temporal
any time
NCT02650024_exc_T10
Procedure
FibroScan
NCT02650024_exc_T11
Temporal
within 12 months
NCT02650024_exc_T12
Measurement
liver stiffness
NCT02650024_exc_T13
Value
=9.5 kilo Pascal
NCT02650024_exc_T14
Measurement
AST to platelet ratio index (APRI)
NCT02650024_exc_T15
Value
=2.0
NCT02650024_exc_T16
Measurement
Fibrosis-4 (FIB-4)
NCT02650024_exc_T17
Value
=3.25
NCT02650024_exc_T19
Condition
allergy
NCT02650024_exc_T20
Condition
sensitivity
NCT02650024_exc_T21
Condition
hypersensitivity
NCT02650024_exc_T22
Drug
components of study drugs
NCT02650024_exc_T23
Scope
allergy/sensitivity or any hypersensitivity
NCT02650024_exc_T24
Condition
Hemochromatosis
NCT02650024_exc_T25
Condition
Alpha-1 antitrypsin deficiency
NCT02650024_exc_T26
Condition
Wilson's disease
NCT02650024_exc_T27
Condition
Autoimmune hepatitis
NCT02650024_exc_T28
Condition
Alcoholic liver disease
NCT02650024_exc_T29
Condition
Drug-related liver disease
NCT02650024_exc_T30
Condition
stroke
NCT02650024_exc_T31
Condition
head injury
NCT02650024_exc_T32
Condition
developmental learning disability
NCT02650024_exc_T33
Condition
NC confounding conditions
NCT02650024_exc_T34
Scope
stroke, head injury, or developmental learning disability
NCT02650024_exc_T35
Drug
anti-inflammatory drugs
NCT02650024_exc_T36
Drug
pegylated interferon
NCT02650024_exc_T37
Drug
PEG-IFN
NCT02650024_exc_T38
Procedure
treatment
NCT02650024_exc_T39
Temporal
recent
NCT02650024_exc_T40
Temporal
Current
NCT02650024_exc_T41
Scope
Current or recent
NCT02650024_exc_T42
Condition
active inflammatory process
NCT02650024_exc_T43
Qualifier
Other
NCT02650024_exc_T44
Condition
major infection
NCT02650024_exc_T45
Condition
malignancy
NCT02650024_exc_T46
Condition
rheumatoid arthritis
NCT02650024_exc_T47
Condition
autoimmune disorder
NCT02650024_exc_T48
Scope
major infection, malignancy, rheumatoid arthritis/autoimmune disorder
NCT02650024_exc_T49
Temporal
within the prior 28 days
NCT02650024_exc_T50
Procedure
magnetic resonance imaging (MRI)
NCT02650024_exc_T51
Condition
Contraindications
NCT02650024_exc_T52
Condition
Bleeding diathesis
NCT02650024_exc_T53
Condition
thrombocytopenia
NCT02650024_exc_T54
Drug
anticoagulants
NCT02650024_exc_T55
Condition
contraindicate
NCT02650024_exc_T56
Procedure
lumbar puncture
NCT02650024_exc_T57
Temporal
active
NCT02650024_exc_T58
Qualifier
Uncontrolled
NCT02650024_exc_T59
Condition
depression
NCT02650024_exc_T60
Scope
Uncontrolled or active
NCT02650024_exc_T61
Condition
psychiatric disorder
NCT02650024_exc_T62
Qualifier
other
NCT02650024_exc_T63
Scope
depression or other psychiatric disorder
NCT02650024_exc_T64
Condition
alcohol use or dependence
NCT02650024_exc_T65
Condition
or d at, in the opinio
NCT02650024_exc_T66
Temporal
Active
NCT02650024_exc_T67
Scope
drug or alcohol use or dependence
NCT02650024_exc_T68
Temporal
acute
NCT02650024_exc_T69
Temporal
active
NCT02650024_exc_T70
Condition
AIDS-defining opportunistic infections
NCT02650024_exc_T71
Temporal
within 12 weeks prior to study entry
NCT02650024_exc_T72
Scope
active or acute