Conditions: HIV-1 Infection
Keywords: HIV 1 Infection HIV Virologically-Suppressed Antiretroviral agents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 275
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the efficacy of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) relative to continuing on a baseline regimen consisting of abacavir/lamivudine (ABC/3TC) plus a 3rd antiretroviral agent in HIV-1 infected participants.

Detailed description:

Arms:
arm 1: Participants will switch to E/C/F/TAF FDC and receive treatment for 48 weeks. arm 2: Participants will maintain prior regimen of ABC/3TC plus a third antiretroviral agent for 24 weeks followed by a delayed switch to E/C/F/TAF FDC.

Note: the prior regimen is determined by the participant's clinician (prior to entry into the study) and will consist of one of the third antiretroviral agents listed.

Interventions: intervention 1: E/C/F/TAF intervention 2: ABC/3TC intervention 3: Third Antiretroviral Agent
Intervention descriptions: intervention 1: 150/150/200/10 mg FDC tablets administered orally once daily intervention 2: 600/300 mg tablets administered orally once daily intervention 3: Third antiretroviral agents could include one of the following:

* ATV+cobicistat (COBI; Tybost®) or ATV/COBI FDC
* DRV+COBI or DRV/COBI FDC
* darunavir (DRV; Prezista®) + RTV
* lopinavir/ritonavir (LPV/r; Kaletra®)
* atazanavir (ATV; Reyataz®) + ritonavir (RTV; Norvir®)
* efavirenz (EFV; Sustiva®)
* etravirine (ETR; Intelence®)
* nevirapine (NVP; Viramune®)
* rilpivirine (RPV; Edurant®)
* dolutegravir (DTG; Tivicay®)
* raltegravir (RAL; Isentress®)
* fosamprenavir (FPV; Lexiva®) + RTV
* saquinavir (SQV; Invirase®) + RTV
* ATV (no booster)

Drug classes:

* Protease inhibitors (PI): LPV/r, ATV, RTV, ATV, DRV, FPV and SQV
* Pharmacokinetic enhancer: COBI
* Non-nucleoside reverse transcriptase inhibitors (NNRTI): EFV, RPV, NVP, and ETR
* Integrase inhibitors: RAL and DTG

Protocol document:
SAP_002.pdf: 
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Prot_001.pdf: 


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TABLE OF CONTENTS
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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
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Clinical Trials.gov 
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Preclinical Pharmacology and Toxicology
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Clinical Trials of E/C/F/TAF
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1.3.
Rationale for This Study
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DGXOWSDWLHQWVZKR DUHYLURORJLFDOO\VXSSUHVVHG7KLVVWXG\VHHNVWRHQUROODODUJHQXPEHURI
VXEMHFWVWRDGGUHVVWKLVJDSLQWKHFOLQLFDOOLWHUDWXUH$VSDUWRIWKHHQUROOPHQWXSWRVXEMHFWV
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1.4.
Risk/Benefit Assessment for the Study
3RWHQWLDOULVNVRIDSDWLHQW¶VVWXG\LQYROYHPHQWLQFOXGHVZLWFKLQJWRDQXQIDPLOLDUUHJLPHQZLWK
SRWHQWLDOORVVRIYLURORJLFFRQWURO DQGRUQHZDGYHUVHHYHQWV WKHLQFRQYHQLHQFHRIPRUHIUHTXHQW
FOLQLFYLVLWVDQGODERUDWRU\EORRGGUDZVDQGWKHDVVRFLDWHGSDLQDQGGLVFRPIRUWRISKOHERWRP\
6WUDWHJLHVWRPLWLJDWHWKHVHULVNVLQFOXGHFORVHPRQLWRULQJRIYLUDOORDG&'7FHOOFRXQWDQG
RWKHUODEYDOXHVDVZHOODVPRQLWRULQJRIDGYHUVHHYHQWV3DUDPHWHUVIRUGLVFRQWLQXDWLRQRIWKH
VWXG\GUXJGXHWRDGYHUVHHYHQWVRUODFNRIHIILFDF\ZLOOEHZHOOGHILQHGDQGFORVHO\IROORZHG
3RWHQWLDOEHQHILWVPD\LQFOXGHWKHSDWLHQWUHFHLYLQJD)'& DQWLUHWURYLUDO(&)7$)UHJLPHQWKDW
LVPRUHFRQYHQLHQWOHDGLQJWRLPSURYHGDGKHUHQFHZLWKSRWHQWLDOO\IHZHUDGYHUVHHYHQWVWKDQ
WKHFXUUHQWUHJLPHQ
&RQVLGHULQJWKH DERYHWKHEHQHILWULVNEDODQFHIRUWKLVVWXG\LVFRQVLGHUHGSRVLWLYH
1.5.
Compliance
7KLVVWXG\ZLOOEHFRQGXFWHGLQFRPSOLDQFHZLWKWKLVSURWRFRO*RRG&OLQLFDO 3UDFWLFH*&3
DQGDOODSSOLFDEOHUHJXODWRU\UHTXLUHPHQWV


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2.
OBJECTIVES
7KHSULPDU\REMHFWLYHRIWKLVVWXG\LV
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7RHYDOXDWHWKHHIILFDF\ RIVZLWFKLQJWR(&)7$))'&UHODWLYHWRFRQWLQXLQJRQ DEDVHOLQH
UHJLPHQFRQVLVWLQJRI$%&7&SOXV DWKLUGDQWLUHWURYLUDODJHQWLQPDLQWDLQLQJ+,951$
 FRSLHVP/DW:HHNXVLQJ)'$VQDSVKRWDOJRULWKPLQYLURORJLFDOO\VXSSUHVVHG
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7KHVHFRQGDU\REMHFWLYHVRIWKLVVWXG\DUH
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7RHYDOXDWH WKHSURSRUWLRQRIVXEMHFWVPDLQWDLQLQJ YLURORJLFDOUHVSRQVHGHILQHGDV
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
7RHYDOXDWHFKDQJHVIURPEDVHOLQHLQ&' FHOOFRXQWVDW:HHNVDQG

7RHYDOXDWHWKHVDIHW\DQGWROHUDELOLW\RIWKHWZRWUHDWPHQW JURXSV RYHUDQGZHHNV


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3.
STUDY DESIGN
3.1.
Endpoints
7KHSULPDU\HQGSRLQWRIWKLVVWXG\LV
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3URSRUWLRQRIVXEMHFWVZLWK+,951$FRSLHVP/ DW:HHN DVGHILQHGE\WKH
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7KHVHFRQGDU\ HIILFDF\ HQGSRLQWVRIWKLVVWXG\DUH
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3URSRUWLRQRIVXEMHFWVZLWK+,951$FRSLHVP/ DW:HHNV DQG DVGHILQHGE\
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7KHFKDQJHIURPEDVHOLQHLQ&' FHOOFRXQWVDW:HHNVDQG
3.2.
Study Design
7KLVSURWRFROGHVFULEHVDUDQGRPL]HGRSHQODEHOPXOWLFHQWHU VWXG\WRHYDOXDWHWKHVDIHW\DQG
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WKH ,QYHVWLJDWRU WR(&)7$))'&WDEOHWFRPSDUHGWRVWD\LQJRQWKHLUFXUUHQWUHJLPHQLQ +,9
LQIHFWHGDGXOWVXEMHFWV ZKRDUHYLURORJLFDOO\VXSSUHVVHG+,9 51$FRSLHVP/RQD
VWDEOHUHJLPHQFRQWDLQLQJ$%&7&IRUFRQVHFXWLYHPRQWKVSULRUWRVFUHHQLQJ
3.3.
Study Treatments
$W'D\DOOVXEMHFWVZLOOEHUDQGRPL]HG WRRQHRIWZRJURXSVHLWKHUVZLWFKLPPHGLDWHO\
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
Treatment Group 1: ,PPHGLDWHVZLWFK IURP$%&7&SOXVDWKLUGDQWLUHWURYLUDODJHQWWR
(&)7$) )'&Q 
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Treatment Group 2: &RQWLQXH RQWKHFXUUHQW UHJLPHQRI$%&7&SOXVD
WKLUG DQWLUHWURYLUDODJHQW IRUZHHNVIROORZHGE\DGHOD\HGVZLWFKWR(&)7$) )'&
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Antiretroviral Class
Agents
%RRVWHG3,
$79&2%,RU$79&2%,)'&'59&2%,RU'59&2%,)'&
'59579 /39U $79579
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4.
SUBJECT POPULATION
4.1.
Number of Subjects and Subject Selection
$SSUR[LPDWHO\VXEMHFWVZKRPHHWWKHHOLJLELOLW\FULWHULDZLOOEHHQUROOHG
4.2.
Inclusion Criteria
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VWXG\
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SULRUWRLQLWLDWLRQRIVWXG\SURFHGXUHV
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  FRQVHFXWLYH PRQWKVSULRUWRWKHVFUHHQLQJ YLVLW 6XEMHFWVPXVWEHRQWKHLU
ILUVW RU VHFRQG $59UHJLPHQ 5HIHUWR7DEOH  IRUDOORZHGWKLUGDJHQWVRIWKH
FXUUHQW UHJLPHQ
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VFUHHQLQJYLVLWPHDVXUHGDWOHDVWWZLFHXVLQJWKHVDPHDVVD\
D ,QWKHSUHFHGLQJPRQWKVSULRUWRVFUHHQLQJRQHHSLVRGHRI³EOLS´
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  FRSLHVP/LPPHGLDWHO\EHIRUHDQGDIWHUWKH³EOLS´
E 7RGHWHUPLQHYLURORJLFVXSSUHVVLRQLQWKHSUHFHGLQJPRQWKVSULRUWRVFUHHQLQJWKH
ORZHUOLPLWRITXDQWLILFDWLRQ//24E\WKHORFDO+,951$DVVD\PD\EHXVHGRQO\LI
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NQRZQUHVLVWDQFHWR7')RU )7&LQFOXGLQJEXWQRWOLPLWHGWRWKHSUHVHQFHRIUHYHUVH
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Table 4-1.
Allowable Antiretroviral Agents of Pre-Existing Regimen
Antiretroviral Class
Agents
%RRVWHG3,
$79&2%,RU$79&2%,)'&'59&2%,RU'59&2%,)'&
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4.3.
Exclusion Criteria
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 6XEMHFWVZLOOKDYHQRHYLGHQFHRISUHYLRXVYLURORJLFIDLOXUHRQD3,URU,167,EDVHG
UHJLPHQZLWKRUZLWKRXWUHVLVWDQFHWRHLWKHUFODVVRI$59
 $QHZ$,'6GHILQLQJFRQGLWLRQGLDJQRVHGZLWKLQWKHGD\VSULRUWRVFUHHQLQJ
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 +HSDWLWLV&YLUXVWKDWZRXOGUHTXLUH WKHUDS\GXULQJWKHVWXG\
 3RVLWLYH+HSDWLWLV%VXUIDFHDQWLJHQ+%V$J
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YDULFHDO EOHHGLQJ
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VXEMHFWVWXG\FRPSOLDQFH
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RWKHUWKDQFXWDQHRXV.DSRVL
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DQWLIXQJDOWKHUDS\ZLWKLQGD\VSULRUWR'D\


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Table 4-2.
Disallowed Agents
Drug Class
Agents Disallowed*
$OSKD$GUHQHUJLF5HFHSWRU$QWDJRQLVWV
$OIX]RVLQ
&DOFLXP&KDQQHO%ORFNHUV
%HSULGLO
$QWLFRQYXOVDQWV
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2[FDUED]HSLQH
$QWLKLVWDPLQHV
$VWHPL]ROH7HUIHQDGLQH
$QWLP\FREDFWHULDOV
5LIDPSLQ5LIDSHQWLQH5LIDEXWLQ
(UJRW'HULYDWLYHV
(UJRWDPLQH(UJRQRYLQH
'LK\GURHUJRWDPLQH
0HWK\OHUJRQRYLQH
(UJRPHWULQH
*,0RWLOLW\$JHQWV
&LVDSULGH
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6W-RKQ¶V:RUW(FKLQDFHD
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6LPYDVWDWLQ/RYDVWDWLQ
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6DOPHWHURO
1HXUROHSWLFV
3LPR]LGH
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6LOGHQDILOIRU3$+
6HGDWLYHV+\SQRWLFV
2UDOO\DGPLQLVWHUHG0LGD]RODP7ULD]RODP
*
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5.
INVESTIGATIONAL MEDICINAL PRODUCTS
5.1.
Randomization, Blinding and Treatment Codes
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5DQGRPL]DWLRQZLOOEHVWUDWLILHGE\DJH \HDUV RU\HDUV
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Treatment Group 1: ,PPHGLDWHVZLWFKIURP$%&7&SOXVDWKLUGDQWLUHWURYLUDODJHQWWR
(&)7$) )'&Q DSSUR[LPDWHO\
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Treatment Group 2: &RQWLQXH RQWKHFXUUHQW UHJLPHQ RI$%&7&SOXVD
WKLUG DQWLUHWURYLUDODJHQW IRUZHHNVIROORZHGE\DGHOD\HGVZLWFKWRIL[HGGRVHUHJLPHQ
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2QFHHOLJLELOLW\KDVEHHQFRQILUPHGHDFKVXEMHFWZLOOEHDVVLJQHGDXQLTXHVXEMHFWQXPEHUXVLQJ
,QWHUDFWLYH:HE5HVSRQVH6\VWHP,:562QFHDVXEMHFWQXPEHUKDVEHHQDVVLJQHGLWZLOOQRW
EHUHDVVLJQHGWRDQ\RWKHUVXEMHFW7KHVXEMHFWQXPEHUDVVLJQPHQWDQG UDQGRPL]DWLRQPD\EH
SHUIRUPHGXSWR GD\VSULRUWRWKHLQFOLQLF'D\ YLVLWSURYLGHGWKDWDOO VFUHHQLQJSURFHGXUHV
KDYHEHHQFRPSOHWHGDQGVXEMHFWHOLJLELOLW\KDVEHHQFRQILUPHG
Randomization and baseline visit cannot occur until subject eligibility has been confirmed.
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7UHDWPHQW*URXS DQGDW:HHNDQGRQZDUGVIRUVXEMHFWVLQ7UHDWPHQW *URXS All Day 1
visit tests and procedures must be completed prior to the administration of the first dose of 
the study drug ,QLWLDWLRQRIWUHDWPHQWZLWKWKHVWXG\GUXJPXVWWDNHSODFHZLWKLQKRXUVDIWHU
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7UHDWPHQW*URXS
5.2.
Description and Handling of E/C/F/TAF FDC
5.2.1.
Formulation
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7$)IXPDUDWH
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DOXPLQXPODNHSRO\HWK\OHQHJO\FROSRO\YLQ\ODOFRKROWDOFWLWDQLXPGLR[LGHDQG\HOORZLURQ
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5.2.2.
Packaging and Labeling
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5.2.3.
Storage and Handling
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5.3.
Dosage and Administration of E/C/F/TAF FDC
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5.4.
Prior and Concomitant Medications
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Table 5-1.
Prior and Concomitant Medications
Drug Class
Agents Disallowed
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Pretreatment Assessments
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Treatment Assessments
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Treatment Assessments (Week 24)
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6.5.
Post-treatment Assessments
6.5.1.
Early Study Drug Discontinuation (ESDD) Visit
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6.6.
Assessments for Premature Discontinuation from Study
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6.7.
Criteria for Discontinuation of Study Treatment
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6.8.
Other Evaluations
6.8.1.
Blood and Urine Storage
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6.8.2.
Bone Safety and Inflammation
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Markers of Platelet Function and Coagulation
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6.8.4.
Markers of Renal Tubular Function
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6.9.
End of Study
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6.10.
Post Study Care
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6.11.
Virologic Failure
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6.11.1.
Management of Virologic Failure
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7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT
7.1.
Definitions of Adverse Events, Adverse Reactions, and Serious Adverse Events
7.1.1.
Adverse Events
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7.1.2.
Serious Adverse Events
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Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
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7.2.
Assessment of Adverse Events and Serious Adverse Events
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7.2.1.
Assessment of Causality for Study Drugs and Procedures
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7.2.2.
Assessment of Severity
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7.3.
Investigator Requirements and Instructions for Reporting Adverse Events
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7.3.1.
Adverse Events
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Serious Adverse Events
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7.3.3.
Electronic Serious Adverse Event (eSAE) Reporting Process
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Special Situations Reports
7.5.1.
Definitions of Special Situations
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Instructions for Reporting Special Situations
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Toxicity Management
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Management of Possible Abacavir Hypersensitivity Reaction
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7.6.6.
Management of Potential Nephrotoxicity
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8.
STATISTICAL CONSIDERATIONS
8.1.
Analysis Objectives and Endpoints
8.1.1.
Analysis Objectives
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8.1.2.
Primary Endpoint
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8.1.3.
Secondary Endpoint
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8.2.
Analysis Conventions
8.2.1.
Analysis Sets
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8.3.
Demographic Data and Baseline Characteristics
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8.4.
Efficacy Analysis
8.4.1.
Primary Analysis
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8.4.2.
Secondary Analyses
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8.5.
Safety Analysis
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8.5.1.
Extent of Exposure
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8.5.2.
Adverse Events
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8.5.3.
Laboratory Evaluations
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8.5.4.
Other Safety Evaluations
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8.6.
Biomarker Analysis
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Sample Size
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9.
RESPONSIBILITIES
9.1.
Investigator Responsibilities
9.1.1.
Good Clinical Practice
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9.1.2.
Institutional Review Board (IRB) / Independent Ethics Committee (IEC) 
Review and Approval
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9.1.3.
Informed Consent
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9.1.4.
Confidentiality
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9.1.5.
Study Files and Retention of Records
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9.1.6.
Case Report Forms
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9.1.7.
Inspections
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9.1.8.
Protocol Compliance
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9.2.1.
Protocol Modifications
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9.2.2.
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9.3.1.
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10.
REFERENCES
13
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DFWLYDWLRQRIWKHDQWLYLUDODJHQWSKRVSKRQ\OPHWKR[\HWK\ODGHQLQHLQKXPDQ
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1238
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IRU+,9LQIHFWLRQDQGH[SDQGHGVXUYHLOODQFHFDVH GHILQLWLRQIRU$,'6DPRQJ
DGROHVFHQWVDQGDGXOWV00:555
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11.
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Appendix 2.
Study Procedures Table
Study Procedure
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Appendix 4.
GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities
$QWLYLUDO7R[LFLW\*UDGLQJ6FDOH9HUVLRQ$SULO
HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
+HPRJORELQ
+,9326,7,9(
Adult and Pediatric 57 Days
 WR  JG/
WR J/
 WR JG/
 WR  J/
WR JG/
WR J/
 JG/
 J/
+,91(*$7,9(
Adult and Pediatric 57 Days 
 WR  JG/
 WR  J/
25
$Q\GHFUHDVHIURP%DVHOLQH
WR JG/
WR J/
WR JG/
WR J/
25
$Q\GHFUHDVHIURP%DVHOLQH
WR JG/
WR J/
WR JG/
WR J/
25
$Q\GHFUHDVHIURP%DVHOLQH
 JG/
 J/
 JG/
 J/
Infant, 36–56 Days
+,9326,7,9( 25
1(*$7,9(
WR JG/
WR J/
WR JG/
WR J/
WRJG/
WRJ/
JG/
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Infant, 22–35 Days
+,9326,7,9( 25
1(*$7,9(
WR JG/
WR J/
WR JG/
WR J/
WR JG/
WR J/
 JG/
 J/
Infant, 1–21 Days
+,9SRVLWLYH RU QHJDWLYH
WR JG/
WR J/
WR JG/
WR J/
WR JG/
WR J/
 JG/
 J/
$EVROXWH1HXWURSKLO&RXQW
$1&
Adult and Pediatric, 
≥ 7 Months#
 WR PP
 WR PP
 WR PP
PP
 WR *,/
 WR*,/
 WR *,/
*,/
$EVROXWH&'&RXQW
+,91(*$7,9(21/<
Adult and Pediatric 
> 13 Years
 WR PP
 WR ȝ/
 WR PP
 WRȝ/
 WR PP
 WR ȝ/
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-XO\
HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
$EVROXWH/\PSKRF\WH&RXQW
+,91(*$7,9(21/<
Adult and Pediatric 
13 Years
WRPP
WR*,/
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WR*,/
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3ODWHOHWV
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 WR *,/
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:%&V
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+\SRILEULQRJHQHPLD
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WR PJG/
 WR PJG/
 PJG/
 WR  J/
 WR J/
WR J/
 J/
+\SHUILEULQRJHQHPLD
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²
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WR ȝJP/
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 ȝJP/
WR PJ/
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WR PJ/
 PJ/
3URWKURPELQ7LPH37
WR 8/1
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8/1
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RISURWKURPELQWLPH,15
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7KURPERSODVWLQ7LPH$377
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 WR 8/1
8/1
0HWKHPRJORELQ
 WR 
 WR 
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3DJH 
-XO\
CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
+\SRQDWUHPLD
WR//1 P(T/
WR  P(T/
WR  P(T/
P(T/
WR //1 PPRO/
WR  PPRO/
WR  PPRO/
PPRO/
+\SHUQDWUHPLD
!8/1WRP(T/
WRP(T/
WRP(T/
P(T/
!8/1WRPPRO/
WRPPRO/
WRPPRO/
PPRO/
+\SRNDOHPLD
Adult and Pediatric
1 Year
WR//1 P(T/
WR  P(T/
WR  P(T/
P(T/
WR //1 PPRO/
WR  PPRO/
WR  PPRO/
PPRO/
Infant <1 Year 
WRP(T/
WRPPRO/
WR  P(T/
WRPPRO/
WR  P(T/
WRPPRO/
P(T/
PPRO/
+\SHUNDOHPLD
Adult and Pediatric
1 Year
WRP(T/
WRPPRO/
WR P(T/
WR PPRO/
WR P(T/
WR PPRO/
P(T/
PPRO/
Infant <1 Year
!8/1WRP(T/
!8/1WRPPRO/
!WRP(T/
!WRPPRO/
WR P(T/
WR PPRO/
P(T/
PPRO/
+\SRJO\FHPLD
Adult and Pediatric
1 Month
 WR PJG/
WR PPRO/
WR  PJG/
WR  PPRO/
WR  PJG/
WR  PPRO/
PJG/
PPRO/
Infant, 1 Month
WR PJG/
WR PPRO/
WR PJG/
WR PPRO/
WR PJG/
WR PPRO/
PJG/
PPRO/
+\SHUJO\FHPLD1RQIDVWLQJ
 WR PJG/
WR PJG/
WR PJG/
PJG/
WR PPRO/
WR PPRO/
WR PPRO/
PPRO/
+\SHUJO\FHPLD)DVWLQJ
WRPJG/
WRPPRO/
!WRPJG/
!WRPPRO/
!WRPJG/
!WRPPRO/
!PJG/
!PPRO/


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CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
+\SRFDOFHPLD
FRUUHFWHGIRUDOEXPLQ LI
DSSURSULDWH
Adult and Pediatric
2 Years
//1PJG/
WR//1 PPRO/
WR PJG/
WR PPRO/
WR  PJG/
WR PPRO/
 PJG/
 PPRO/
Pediatric ≥7 days -2 Years
WRPJG/
WRPPRO/
WRPJG/
WRPPRO/
WRPJG/
WRPPRO/
PJG/
PPRO/
Infant, 7 Days
WRPJG/
WRPPRO/
WRPJG/
WRPPRO/
WRPJG/
WRPPRO/
PJG/
PPRO/
+\SHUFDOFHPLD FRUUHFWHGIRU
DOEXPLQ LIDSSURSULDWH
Adult and Pediatric 7 Days
!8/1 WRPJG/
WRPJG/
WRPJG/
PJG/
!8/1WRPPRO/
WRPPRO/
WRPPRO/
PPRO/
Infant, 7 Days
WRPJG/
WRPPRO/
WRPJG/
!WRPPRO/
WRPJG/
!WRPPRO/
PJG/
!PPRO/
+\SRFDOFHPLDLRQL]HG
PJG/WR //1
WRPJG/
WR PJG/
PJG/
PPRO/WR //1
WR PPRO/
WR PPRO/
PPRO/
+\SHUFDOFHPLDLRQL]HG
8/1WRPJG/
WRPJG/
WRPJG/
PJG/
8/1WRPPRO/
WRPPRO/
WRPPRO/
PPRO/
+\SRPDJQHVHPLD
WR //1PJG/
WR//1 P(T/
WR PJG/
WRP(T/
WR PJG/
WRP(T/
PJG/
P(T/
WR //1 PPRO/
WR PPRO/
WR PPRO/
PPRO/


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3URWRFRO*686
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3DJH 
-XO\
CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
+\SRSKRVSKDWHPLD
Adult and Pediatric
14 Years
WR//1PJG/
WR//1PPRO/
WR PJG/
WR PPRO/
WR PJG/
WR PPRO/
PJG/
PPRO/
Pediatric 1 Year–14 Years 
WR//1 PJG/
WR//1 PPRO/
WRPJG/
WR  PPRO/
WRPJG/
WR PPRO/
PJG/
 PPRO/
Pediatric 1 Year
WR//1 PJG/
WR//1 PPRO/
WR PJG/
 WR  PPRO/
WRPJG/
WRPPRO/
PJG/
 PPRO/
+\SHUELOLUXELQHPLD
Adult and Pediatric > 14 Days
WR8/1
WR8/1
WR8/1
8/1
Infant, 14 Days
QRQKHPRO\WLF
1$
 WRPJG/
WRȝPRO/
WRPJG/
!WRȝPRO/
PJG/
!ȝPRO/
Infant, 14 Days
KHPRO\WLF
1$
1$
WRPJG/
WRȝPRO/
PJG/
!ȝPRO/
%ORRG8UHD1LWURJHQ
WR8/1
WR8/1
WR8/1
8/1
+\SHUXULFHPLD
!8/1 WRPJG/
WRPJG/
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Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements
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2) Contraception Requirements for Female Subjects
a) Study Drug Effects on Pregnancy and Hormonal Contraception
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