a licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load. NOTE: The term "licensed" refers to a United States Food and Drug Administration (FDA)-approved kit, which is required for all IND studies, or for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country and validated internally. Non-US sites are encouraged to use US FDA-approved methods for IND studies. WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA. OR
Documentation of HIV diagnosis in the medical record by a healthcare provider.
Tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide fumarate (TAF)/TAF-containing fixed-dose combination regimens
Ritonavir (RTV) to cobicistat (COBI)/COBI-containing fixed-dose combination regimens
TDF to TAF/TAF-containing fixed-dose combination regimens
RTV to COBI/COBI-containing fixed-dose combination regimens
HIV-1 plasma RNA less than 50 copies/mL obtained within 90 days prior to study entry by any FDA-approved assay at any United States laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.
No more than one HIV-1 plasma RNA greater than or equal to 50 and less than 200 copies/mL (only one "blip") in the past 6 months with a subsequent HIV-1 plasma RNA less than 50 copies/mL. NOTE: There should be no plasma HIV-1 RNA greater than 200 copies/mL within the 6 months prior to study entry.
HAND diagnosis (ANI, MND, or HAD) within 60 days prior to study entry. HAND is defined as at least mild impairment on neurocognitive testing (more than one standard deviation below appropriate normative data in two domains of functioning) and no severely confounding factors.
Absolute neutrophil count (ANC) greater than or equal to 500/mm^3
Hemoglobin greater than or equal to 7.5 g/dL
Platelet count greater than or equal to 40,000/mm^3
Creatinine less than or equal to 2.0 x upper limit of normal (ULN)
Aspartate transaminase (AST) less than or equal to 5 x ULN
Alanine transaminase (ALT) less than 3 x ULN
Alkaline phosphatase less than or equal to 5 x ULN
Total bilirubin less than 1.5 x ULN. NOTE: If the potential participant is taking an indinavir (IDV)- or atazanavir (ATV)-containing regimen at the time of screening, total bilirubin less than or equal to 5 x ULN is acceptable.
Creatinine clearance (CrCl) greater than or equal to 60 mL/min, either measured or estimated by Cockcroft-Gault equation. NOTE: A calculator for estimating the CrCl can be found at www.fstrf.org/ACTG/ccc.html
Females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, ie, who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, hysterectomy or bilateral salpingectomy or bilateral oophorectomy or tubal ligation) must have a negative serum or urine pregnancy test by any US clinic or laboratory that has a CLIA certification or its equivalent, or is using a point of care (POC) / CLIA-waived test, or at any network-approved non-US laboratory or clinic that operates in accordance with GCLP and participates in appropriate external quality assurance programs within 48 hours prior to study entry
Females of reproductive potential must agree not to participate in the conception process (ie, active attempt to become pregnant, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, must use at least one reliable form of contraception. Female participants must use contraceptives while receiving study treatment and for 6 weeks after stopping study treatment. More information on this criterion is available in the protocol.
Men and women 18 years of age and older who are able to complete the neuropsychological tests
Ability and willingness of participant or a legally authorized representative (see protocol for more information) to provide informed consent
Ability and willingness to take oral study medications

NCT02519777_inc_T2
Condition
HIV diagnosis
NCT02519777_inc_T3
Drug
Tenofovir disoproxil fumarate (TDF)
NCT02519777_inc_T4
Drug
tenofovir alafenamide fumarate (TAF)
NCT02519777_inc_T5
Procedure
TAF-containing fixed-dose combination regimens
NCT02519777_inc_T6
Drug
Ritonavir (RTV)
NCT02519777_inc_T7
Drug
cobicistat (COBI)
NCT02519777_inc_T8
Procedure
COBI-containing fixed-dose combination regimens
NCT02519777_inc_T9
Drug
TAF
NCT02519777_inc_T10
Drug
TDF
NCT02519777_inc_T11
Procedure
TAF-containing fixed-dose combination regimens
NCT02519777_inc_T12
Drug
RTV
NCT02519777_inc_T13
Drug
COBI
NCT02519777_inc_T14
Procedure
COBI-containing fixed-dose combination regimens
NCT02519777_inc_T15
Measurement
HIV-1 plasma RNA
NCT02519777_inc_T16
Value
less than 50 copies/mL
NCT02519777_inc_T17
Temporal
within 90 days prior to study entry
NCT02519777_inc_T18
Reference_point
study entry
NCT02519777_inc_T20
Multiplier
No more than one
NCT02519777_inc_T21
Measurement
HIV-1 plasma RNA
NCT02519777_inc_T22
Value
greater than or equal to 50 and less than 200 copies/mL
NCT02519777_inc_T23
Temporal
in the past 6 months
NCT02519777_inc_T24
Measurement
HIV-1 plasma RNA
NCT02519777_inc_T25
Value
less than 50 copies/mL
NCT02519777_inc_T26
Temporal
subsequent
NCT02519777_inc_T27
Negation
no
NCT02519777_inc_T28
Measurement
plasma HIV-1 RNA
NCT02519777_inc_T29
Value
greater than 200 copies/mL
NCT02519777_inc_T30
Temporal
within the 6 months prior to study entry
NCT02519777_inc_T31
Condition
HAND
NCT02519777_inc_T32
Condition
ANI
NCT02519777_inc_T33
Condition
MND
NCT02519777_inc_T34
Condition
HAD
NCT02519777_inc_T35
Scope
ANI, MND, or HAD
NCT02519777_inc_T36
Temporal
within 60 days prior to study entry
NCT02519777_inc_T39
Value
more than one standard deviation below appropriate normative data
NCT02519777_inc_T37
Measurement
neurocognitive testing
NCT02519777_inc_T38
Multiplier
in two domains of functioning
NCT02519777_inc_T40
Qualifier
at least mild
NCT02519777_inc_T41
Value
impairment
NCT02519777_inc_T42
Condition
severely confounding factors
NCT02519777_inc_T43
Negation
no
NCT02519777_inc_T44
Scope
at least mild impairment on neurocognitive testing (more than one standard deviation below appropriate normative data in two domains of functioning) and no severely confounding factors
NCT02519777_inc_T45
Measurement
Absolute neutrophil count (ANC)
NCT02519777_inc_T46
Value
greater than or equal to 500/mm^3
NCT02519777_inc_T47
Measurement
Hemoglobin
NCT02519777_inc_T48
Value
greater than or equal to 7.5 g/dL
NCT02519777_inc_T49
Measurement
Platelet count
NCT02519777_inc_T50
Value
greater than or equal to 40,000/mm^3
NCT02519777_inc_T51
Measurement
Creatinine
NCT02519777_inc_T52
Value
less than or equal to 2.0 x upper limit of normal (ULN)
NCT02519777_inc_T53
Measurement
Aspartate transaminase (AST)
NCT02519777_inc_T54
Value
less than or equal to 5 x ULN
NCT02519777_inc_T55
Measurement
Alanine transaminase (ALT)
NCT02519777_inc_T56
Value
less than 3 x ULN
NCT02519777_inc_T57
Measurement
Alkaline phosphatase
NCT02519777_inc_T58
Value
less than or equal to 5 x ULN
NCT02519777_inc_T59
Measurement
Total bilirubin
NCT02519777_inc_T60
Value
less than 1.5 x ULN
NCT02519777_inc_T61
Drug
indinavir (IDV)
NCT02519777_inc_T62
Drug
atazanavir (ATV)
NCT02519777_inc_T63
Procedure
regimen
NCT02519777_inc_T64
Scope
indinavir (IDV)- or atazanavir (ATV)
NCT02519777_inc_T65
Temporal
at the time of screening
NCT02519777_inc_T66
Measurement
total bilirubin
NCT02519777_inc_T67
Value
less than or equal to 5 x ULN
NCT02519777_inc_T68
Scope
indinavir (IDV)- or atazanavir (ATV)-containing regimen at the time of screening, total bilirubin less than or equal to 5 x ULN
NCT02519777_inc_T69
Scope
Total bilirubin less than 1.5 x ULN
NCT02519777_inc_T70
Measurement
Creatinine clearance (CrCl)
NCT02519777_inc_T71
Value
greater than or equal to 60 mL/min
NCT02519777_inc_T72
Procedure
Cockcroft-Gault equation
NCT02519777_inc_T75
Person
women
NCT02519777_inc_T76
Person
Men
NCT02519777_inc_T77
Value
older wh le to com
NCT02519777_inc_T78
Person
age
NCT02519777_inc_T79
Observation
able to complete
NCT02519777_inc_T80
Procedure
neuropsychological tests