Major depressive disorder with psychotic features
Traumatic Brain Injury (TBI) with a clear impact on activities of daily living
Developmental delay, intellectual deficit, and/or severe educational disability resulting in some dependence for activities of daily living
Ongoing substance use disorder with significant impact on activities of daily living. Difficult or impossible to determine whether cognitive or functional decline is due to substance use or HIV, or both
Evidence of intoxication or withdrawal during the screening evaluation
Central nervous system (CNS) infections or opportunistic conditions: brain abscess (bacterial, mycobacterial, fungal or Toxoplasma), meningitis with persistent neurologic impairment, primary CNS lymphoma, progressive multifocal leukoencephalopathy (PML), or another structural brain lesion with neurological sequelae
Other CNS conditions: non-opportunistic primary or metastatic brain tumors, uncontrolled seizure disorder, progressive multiple sclerosis, stroke with neurological sequelae, or dementia due to causes other than HIV (eg, Alzheimer's disease)
Constitutional illness (eg, persistent unexplained fever, diarrhea, significant weight loss, disabling weakness) within 30 days of screening
Known untreated B12 deficiency or malnutrition (body mass index [BMI] less than 18) at screening
Evidence of current hepatitis C virus infection (HCV) (ie, HCV antibody [Ab] positive within 90 days prior to study entry unless also shown to be plasma HCV RNA negative within the same time period)
Unstable and advanced liver disease (as defined by the presence of at least one of the following: ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice)
Prior or current use of any CCR5 antagonist (such as MVC and cenicriviroc [CVC]) and integrase inhibitor (such as RAL, DTG, and elvitegravir [EVG])
Current use of any medication, including antiretrovirals, prohibited in the study (refer to the A5324 protocol-specific web page [PSWP] for the prohibited medications)
Breastfeeding
Presence of an AIDS-defining opportunistic infection within 6 months prior to entry. Note: Refer to the A5324 Manual of Operations (MOPS) for the list of AIDS-defining opportunistic infections.
Active syphilis or treatment for syphilis within 90 days prior to study entry. NOTE: Active syphilis is defined as four-fold increase in serum rapid plasma reagin (RPR) or venereal disease research laboratory (VDRL) tests in an individual with past syphilis, or newly reactive serum RPR or VDRL with a reactive confirmatory test (enzyme immunoassays [EIA] or chemiluminescent assay [CIA], T. pallidum particle agglutination [TP-PA], or fluorescent treponemal antibody absorbed [FTA-ABS]).
Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation

NCT02519777_exc_T1
Condition
Major depressive disorder
NCT02519777_exc_T2
Scope
psychotic features
NCT02519777_exc_T3
Condition
Traumatic Brain Injury (TBI)
NCT02519777_exc_T4
Condition
impact on activities of daily living
NCT02519777_exc_T5
Condition
Developmental delay
NCT02519777_exc_T6
Condition
intellectual deficit
NCT02519777_exc_T7
Condition
evere educational disability
NCT02519777_exc_T8
Condition
dependence for activities of daily living
NCT02519777_exc_T9
Scope
Developmental delay, intellectual deficit, and/or severe educational disability
NCT02519777_exc_T10
Condition
substance use disorder
NCT02519777_exc_T11
Temporal
Ongoing
NCT02519777_exc_T12
Condition
impact on activities of daily living
NCT02519777_exc_T14
Condition
intoxication
NCT02519777_exc_T15
Condition
withdrawal
NCT02519777_exc_T16
Condition
Central nervous system (CNS) infections
NCT02519777_exc_T17
Condition
al nervous system (CNS) infe tunistic conditions: bra
NCT02519777_exc_T18
Condition
brain abscess
NCT02519777_exc_T19
Condition
meningitis
NCT02519777_exc_T20
Condition
neurologic impairment
NCT02519777_exc_T21
Multiplier
persistent
NCT02519777_exc_T22
Qualifier
bacterial
NCT02519777_exc_T23
Qualifier
mycobacterial
NCT02519777_exc_T24
Qualifier
fungal
NCT02519777_exc_T25
Qualifier
Toxoplasma
NCT02519777_exc_T26
Scope
bacterial, mycobacterial, fungal or Toxoplasma
NCT02519777_exc_T27
Condition
CNS lymphoma
NCT02519777_exc_T28
Condition
progressive multifocal leukoencephalopathy (PML)
NCT02519777_exc_T29
Qualifier
another
NCT02519777_exc_T30
Condition
structural brain lesion
NCT02519777_exc_T31
Condition
neurological sequelae
NCT02519777_exc_T32
Scope
brain abscess (bacterial, mycobacterial, fungal or Toxoplasma), meningitis with persistent neurologic impairment, primary CNS lymphoma, progressive multifocal leukoencephalopathy (PML), or another structural brain lesion with neurological sequelae
NCT02519777_exc_T33
Scope
Central nervous system (CNS) infections or opportunistic conditions
NCT02519777_exc_T34
Qualifier
Other
NCT02519777_exc_T35
Condition
CNS conditions
NCT02519777_exc_T36
Qualifier
non-opportunistic
NCT02519777_exc_T37
Qualifier
primary
NCT02519777_exc_T38
Qualifier
primary
NCT02519777_exc_T39
Qualifier
metastatic
NCT02519777_exc_T40
Condition
brain tumors
NCT02519777_exc_T41
Scope
primary or metastatic
NCT02519777_exc_T42
Qualifier
uncontrolled
NCT02519777_exc_T43
Condition
seizure disorder
NCT02519777_exc_T44
Condition
progressive multiple sclerosis
NCT02519777_exc_T45
Condition
stroke
NCT02519777_exc_T46
Condition
neurological sequelae
NCT02519777_exc_T47
Condition
dementia
NCT02519777_exc_T48
Negation
other than
NCT02519777_exc_T49
Condition
HIV
NCT02519777_exc_T50
Condition
Alzheimer's disease
NCT02519777_exc_T51
Scope
other than HIV
NCT02519777_exc_T52
Scope
non-opportunistic primary or metastatic brain tumors, uncontrolled seizure disorder, progressive multiple sclerosis, stroke with neurological sequelae, or dementia due to causes other than HIV (eg, Alzheimer's disease)
NCT02519777_exc_T53
Scope
Other CNS conditions
NCT02519777_exc_T54
Condition
Constitutional illness
NCT02519777_exc_T55
Condition
unexplained fever
NCT02519777_exc_T56
Multiplier
persistent
NCT02519777_exc_T57
Condition
diarrhea
NCT02519777_exc_T58
Qualifier
significant
NCT02519777_exc_T59
Condition
weight loss
NCT02519777_exc_T60
Condition
disabling weakness
NCT02519777_exc_T61
Scope
persistent unexplained fever, diarrhea, significant weight loss, disabling weakness
NCT02519777_exc_T62
Temporal
within 30 days of screening
NCT02519777_exc_T63
Qualifier
untreated
NCT02519777_exc_T64
Condition
B12 deficiency
NCT02519777_exc_T65
Condition
malnutrition
NCT02519777_exc_T66
Measurement
body mass index [BMI]
NCT02519777_exc_T67
Value
less than 18
NCT02519777_exc_T68
Temporal
at screening
NCT02519777_exc_T69
Scope
B12 deficiency or malnutrition (body mass index [BMI] less than 18)
NCT02519777_exc_T70
Temporal
current
NCT02519777_exc_T71
Condition
hepatitis C virus infection (HCV)
NCT02519777_exc_T72
Measurement
HCV antibody [Ab]
NCT02519777_exc_T73
Value
positive
NCT02519777_exc_T74
Mood
Evidence
NCT02519777_exc_T75
Temporal
within 90 days prior to study entry
NCT02519777_exc_T76
Measurement
plasma HCV RNA
NCT02519777_exc_T77
Value
negative
NCT02519777_exc_T78
Temporal
within the same time period
NCT02519777_exc_T79
Scope
HCV antibody [Ab] positive within 90 days prior to study entry unless also shown to be plasma HCV RNA negative within the same time period
NCT02519777_exc_T80
Qualifier
Unstable
NCT02519777_exc_T81
Qualifier
advanced
NCT02519777_exc_T82
Condition
liver disease
NCT02519777_exc_T83
Multiplier
at least one
NCT02519777_exc_T84
Condition
ascites
NCT02519777_exc_T85
Condition
encephalopathy
NCT02519777_exc_T86
Condition
coagulopathy
NCT02519777_exc_T87
Condition
hypoalbuminemia
NCT02519777_exc_T88
Condition
 or gastr r persi
NCT02519777_exc_T89
Condition
gastric varices
NCT02519777_exc_T90
Qualifier
persistent
NCT02519777_exc_T91
Condition
jaundice
NCT02519777_exc_T92
Scope
ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice
NCT02519777_exc_T93
Scope
at least one of the following: ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice
NCT02519777_exc_T94
Temporal
Prior
NCT02519777_exc_T95
Temporal
current
NCT02519777_exc_T96
Drug
CCR5 antagonist
NCT02519777_exc_T97
Drug
MVC
NCT02519777_exc_T98
Drug
cenicriviroc [CVC]
NCT02519777_exc_T99
Scope
MVC and cenicriviroc [CVC]
NCT02519777_exc_T100
Drug
integrase inhibitor
NCT02519777_exc_T101
Drug
RAL
NCT02519777_exc_T102
Drug
DTG
NCT02519777_exc_T103
Drug
elvitegravir [EVG]
NCT02519777_exc_T104
Scope
RAL, DTG, and elvitegravir [EVG]
NCT02519777_exc_T105
Scope
CCR5 antagonist (such as MVC and cenicriviroc [CVC]) and integrase inhibitor (such as RAL, DTG, and elvitegravir [EVG])
NCT02519777_exc_T106
Scope
Prior or current
NCT02519777_exc_T108
Observation
Breastfeeding
NCT02519777_exc_T109
Condition
AIDS-defining opportunistic infection
NCT02519777_exc_T110
Temporal
within 6 months prior to entry
NCT02519777_exc_T111
Temporal
Active
NCT02519777_exc_T112
Condition
syphilis
NCT02519777_exc_T113
Procedure
treatment
NCT02519777_exc_T114
Condition
syphilis
NCT02519777_exc_T115
Temporal
within 90 days prior to study entry
NCT02519777_exc_T116
Reference_point
study entry
NCT02519777_exc_T117
Temporal
Active
NCT02519777_exc_T118
Condition
syphilis
NCT02519777_exc_T119
Value
four-fold increase
NCT02519777_exc_T120
Measurement
serum rapid plasma reagin (RPR)
NCT02519777_exc_T121
Measurement
venereal disease research laboratory (VDRL)
NCT02519777_exc_T122
Condition
syphilis
NCT02519777_exc_T123
Temporal
past
NCT02519777_exc_T124
Value
reactive
NCT02519777_exc_T125
Temporal
newly
NCT02519777_exc_T126
Measurement
serum RPR
NCT02519777_exc_T127
Measurement
VDRL
NCT02519777_exc_T128
Procedure
reactive confirmatory test
NCT02519777_exc_T129
Procedure
enzyme immunoassays [EIA]
NCT02519777_exc_T130
Procedure
chemiluminescent assay [CIA]
NCT02519777_exc_T131
Procedure
T. pallidum particle agglutination [TP-PA]
NCT02519777_exc_T132
Procedure
fluorescent treponemal antibody absorbed [FTA-ABS]
NCT02519777_exc_T133
Scope
enzyme immunoassays [EIA] or chemiluminescent assay [CIA], T. pallidum particle agglutination [TP-PA], or fluorescent treponemal antibody absorbed [FTA-ABS]
NCT02519777_exc_T134
Scope
serum RPR or VDRL
NCT02519777_exc_T135
Scope
serum rapid plasma reagin (RPR) or venereal disease research laboratory (VDRL)
NCT02519777_exc_T136
Scope
four-fold increase in serum rapid plasma reagin (RPR) or venereal disease research laboratory (VDRL) tests in an individual with past syphilis
NCT02519777_exc_T137
Scope
newly reactive serum RPR or VDRL with a reactive confirmatory test (enzyme immunoassays [EIA] or chemiluminescent assay [CIA], T. pallidum particle agglutination [TP-PA], or fluorescent treponemal antibody absorbed [FTA-ABS])
NCT02519777_exc_T138
Scope
four-fold increase in serum rapid plasma reagin (RPR) or venereal disease research laboratory (VDRL) tests in an individual with past syphilis, or newly reactive serum RPR or VDRL with a reactive confirmatory test (enzyme immunoassays [EIA] or chemiluminescent assay [CIA], T. pallidum particle agglutination [TP-PA], or fluorescent treponemal antibody absorbed [FTA-ABS])
NCT02519777_exc_T139
Condition
allergy
NCT02519777_exc_T140
Condition
sensitivity
NCT02519777_exc_T141
Condition
hypersensitivity
NCT02519777_exc_T142
Drug
components of study drugs
NCT02519777_exc_T143
Scope
allergy/sensitivity or any hypersensitivity
NCT02519777_exc_T107
Drug
medication
NCT02519777_exc_T144
Drug
antiretrovirals
NCT02519777_exc_T145
Qualifier
prohibited in the study
NCT02519777_exc_T146
Temporal
Current