Clinical trial NCT02605954
Conditions: HIV-1 Infection
Keywords: HIV 1 Infection HIV Virologically-Suppressed Antiretroviral agents
Sponsor: Gilead Sciences
Start date: 2015-11-18; Completion date: 2018-01-24
Enrollment: 275 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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 documents:
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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
Study Title: 
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IND Number:
EudraCT Number:
Clinical Trials.gov 
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1.
INTRODUCTION
1.1.
Background
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1.2.
Tenofovir Alafenamide (TAF, GS-7340)
1.2.1.
General Information
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1.2.2.
Preclinical Pharmacology and Toxicology
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HVWLPDWHGFUHDWLQLQHFOHDUDQFH!P/PLQZHUHUDQGRPO\DVVLJQHGWRVZLWFKWR
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ZHUH(&)7')Q  ()9)7&7')Q  DQG579ERRVWHG$79)7&7')
Q  7KHPDLQRXWFRPHVZHUHWKHSURSRUWLRQRISDWLHQWVZLWKSODVPD+,951$OHVVWKDQ
FRSLHV SHUP/DW:HHNDVGHILQHGE\WKH86)RRGDQG'UXJ$GPLQLVWUDWLRQ)'$
VQDSVKRWDOJRULWKPSUHVSHFLILHGQRQLQIHULRULW\PDUJLQRIDQGSUHVSHFLILHGUHQDODQG
ERQHHQGSRLQWVDWZHHNV,QWKLVVWXG\RIYLURORJLFDOO\VXSSUHVVHGSDWLHQWVVZLWFKLQJWR
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RI(&)7$)SDWLHQWVDQGRISDWLHQWVPDLQWDLQLQJDQ7')EDVHGUHJLPHQKDYLQJ
SODVPD+,951$OHVVWKDQFRSLHVSHUP/DW:HHNDGMXVWHGGLIIHUHQFH&,
WR3DWLHQWVVZLWFKLQJWR(&)7$)KDGVLJQLILFDQWLPSURYHPHQWVLQVHUXPFUHDWLQLQH
S  DQGH*)5S  WKDQWKRVHPDLQWDLQLQJ7')EDVHGUHJLPHQ7KHUHZHUHQR
*UDGHVHUXPFUHDWLQLQHLQFUHDVHVLQSDWLHQWVWKDWVZLWFKHGWR(&)7$)7KHGLIIHUHQFHLQ
ERQHPLQHUDOGHQVLW\FKDQJHVIURPEDVHOLQHWRZHHNVVLJQLILFDQWO\IDYRUHGWKHSDWLHQWV
VZLWFKLQJWR(&)7$)ZLWKLQFUHDVHVREVHUYHGFRPSDUHGPDLQWDLQLQJDQ7')EDVHGUHJLPHQV
ZKHUHWKHUHZHUHGHFUHDVHVLQPHDQFKDQJHLQ%0'VSLQHYVS  DQGKLS
±YV S  7KHUHZHUHIHZHUGLVFRQWLQXDWLRQVGXHWRDGYHUVHHYHQWVLQWKH
SDWLHQWVVZLWFKLQJWR(&)7$)FRPSDUHGWRFRQWLQXLQJ7')EDVHGUHJLPHQYV
1.3.
Rationale for This Study
/LWWOHGDWDH[LVWUHSRUWLQJRQWKHVDIHW\DQGHIILFDF\LQVZLWFKLQJIURPDQDEDFDYLUODPLYXGLQH
$%&7&SOXVDWKLUGDQWLUHWURYLUDO DJHQWWRDVLPSOHRQFHGDLO\WDEOHWRI(&)7$))'&LQ
DGXOWSDWLHQWVZKR DUHYLURORJLFDOO\VXSSUHVVHG7KLVVWXG\VHHNVWRHQUROODODUJHQXPEHURI
VXEMHFWVWRDGGUHVVWKLVJDSLQWKHFOLQLFDOOLWHUDWXUH$VSDUWRIWKHHQUROOPHQWXSWRVXEMHFWV
ZKRDUH\HDUVRUROGHUZLOOEHHQUROOHG6LQFH6WXG\*686 HQUROOHGDUHODWLYHO\
\RXQJHUSRSXODWLRQWKLVVWXG\ZLOODOVRVHUYHWRSURYLGHGDWDRQWKHVDIHW\DQGHIILFDF\RI
(&)7$))'&LQDQROGHUSRSXODWLRQDQREMHFWLYHLQNHHSLQJZLWKWKHDJLQJRIWKH
+,9LQIHFWHGSRSXODWLRQ


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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

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
+,9LQIHFWHGDGXOWVXEMHFWV
7KHVHFRQGDU\REMHFWLYHVRIWKLVVWXG\DUH

7RHYDOXDWH WKHSURSRUWLRQRIVXEMHFWVPDLQWDLQLQJ YLURORJLFDOUHVSRQVHGHILQHGDV
+,9 51$ FRSLHVP/)'$VQDSVKRWDQDO\VLVDW:HHNV  DQG

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

3URSRUWLRQRIVXEMHFWVZLWK+,951$FRSLHVP/ DW:HHN DVGHILQHGE\WKH
)'$ VQDSVKRWDOJRULWKP
7KHVHFRQGDU\ HIILFDF\ HQGSRLQWVRIWKLVVWXG\DUH

3URSRUWLRQRIVXEMHFWVZLWK+,951$FRSLHVP/ DW:HHNV DQG DVGHILQHGE\
WKH)'$VQDSVKRWDOJRULWKP

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
HIILFDF\RIVZLWFKLQJIURP$%&7&SOXV DWKLUGDQWLUHWURYLUDO DJHQWDVSUHVFULEHGE\
WKH ,QYHVWLJDWRU WR(&)7$))'&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
$W'D\DOOVXEMHFWVZLOOEHUDQGRPL]HG WRRQHRIWZRJURXSVHLWKHUVZLWFKLPPHGLDWHO\
IURP$%&7&WR(&)7$))'&WUHDWPHQW7UHDWPHQW*URXS RUFRQWLQXLQJRQWKHLU
H[LVWLQJUHJLPHQIRUZHHNVIROORZHGE\DGHOD\HGVZLWFK WR(&)7$) )'&
7UHDWPHQW *URXS5DQGRPL]DWLRQZLOOEHVWUDWLILHGE\DJH\HDUVRU\HDUV

Treatment Group 1: ,PPHGLDWHVZLWFK IURP$%&7&SOXVDWKLUGDQWLUHWURYLUDODJHQWWR
(&)7$) )'&Q 

Treatment Group 2: &RQWLQXH RQWKHFXUUHQW UHJLPHQRI$%&7&SOXVD
WKLUG DQWLUHWURYLUDODJHQW IRUZHHNVIROORZHGE\DGHOD\HGVZLWFKWR(&)7$) )'&
Q  
$OORZHGWKLUGDQWLUHWURYLUDO DJHQWVLQFOXGH
Antiretroviral Class
Agents
%RRVWHG3,
$79&2%,RU$79&2%,)'&'59&2%,RU'59&2%,)'&
'59579 /39U $79579
1157,
()9(75193539
,167,
'7*5$/






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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
6XEMHFWVPXVWPHHWDOORIWKHIROORZLQJLQFOXVLRQFULWHULDWREHHOLJLEOHIRUSDUWLFLSDWLRQLQWKLV
VWXG\
 7KHDELOLW\WRXQGHUVWDQGDQGVLJQDZULWWHQLQIRUPHGFRQVHQWIRUPZKLFKPXVWEHREWDLQHG
SULRUWRLQLWLDWLRQRIVWXG\SURFHGXUHV
 $JH\HDUV
 &XUUHQWO\UHFHLYLQJ$%&7& SOXV DWKLUGDQWLUHWURYLUDO $59 DJHQWIRU
  FRQVHFXWLYH PRQWKVSULRUWRWKHVFUHHQLQJ YLVLW 6XEMHFWVPXVWEHRQWKHLU
ILUVW RU VHFRQG $59UHJLPHQ 5HIHUWR7DEOH  IRUDOORZHGWKLUGDJHQWVRIWKH
FXUUHQW UHJLPHQ
 'RFXPHQWHGSODVPD+,951$OHYHOVFRSLHVP/IRUPRQWKVSUHFHGLQJWKH
VFUHHQLQJYLVLWPHDVXUHGDWOHDVWWZLFHXVLQJWKHVDPHDVVD\
D ,QWKHSUHFHGLQJPRQWKVSULRUWRVFUHHQLQJRQHHSLVRGHRI³EOLS´
+,9 51$ !  DQGFRSLHVP/LVDFFHSWDEOHRQO\LI+,951$LV
  FRSLHVP/LPPHGLDWHO\EHIRUHDQGDIWHUWKH³EOLS´
E 7RGHWHUPLQHYLURORJLFVXSSUHVVLRQLQWKHSUHFHGLQJPRQWKVSULRUWRVFUHHQLQJWKH
ORZHUOLPLWRITXDQWLILFDWLRQ//24E\WKHORFDO+,951$DVVD\PD\EHXVHGRQO\LI
LWV//24LVJUHDWHUWKDQFRSLHVP/HJ //24RIFRSLHVP/
 3ODVPD+,951$OHYHOFRSLHVP/DWVFUHHQLQJYLVLW
 'RFXPHQWHGKLVWRULFDOJHQRW\SHSULRUWRVWDUWLQJLQLWLDO$59WKHUDS\$57VKRZLQJQR
NQRZQUHVLVWDQFHWR7')RU )7&LQFOXGLQJEXWQRWOLPLWHGWRWKHSUHVHQFHRIUHYHUVH
WUDQVFULSWDVHUHVLVWDQFHPXWDQWV.509,RUWK\PLGLQHDQDORJDVVRFLDWHGPXWDWLRQV
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JHQRW\SHLVQRWDYDLODEOHVXEMHFWZLOOKDYHSURYLUDOJHQRW\SHDQDO\VLVIRUDUFKLYHGUHVLVWDQFH
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 7RWDOELOLUXELQPJG/RUQRUPDOGLUHFWELOLUXELQVXEMHFWVZLWKGRFXPHQWHG
*LOEHUW¶V V\QGURPHRUZLWKDWD]DQDYLUDVVRFLDWHGK\SHUELOLUXELQHPLDPD\KDYHWRWDOELOLUXELQ
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 $GHTXDWHKHPDWRORJLFIXQFWLRQ
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3ODWHOHWV PP
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+HPRJORELQJG/
 $IHPDOHVXEMHFWLVHOLJLEOHWRHQWHUWKHVWXG\LILWLVFRQILUPHGWKDWVKHLV
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VXEMHFWVXQOHVVSHUPDQHQWO\ VWHULOHRUJUHDWHUWKDQWZR\HDUVSRVWPHQRSDXVDO
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RYDULHVUHPRYHGRUPHGLFDOO\GRFXPHQWHGRYDULDQIDLOXUHRUDUHSRVWPHQRSDXVDOZRPHQ
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VSHFLILHGPHWKRGRIFRQWUDFHSWLRQ RUEHQRQKHWHURVH[XDOO\DFWLYHRUSUDFWLFHVH[XDO
DEVWLQHQFHDV GHILQHGLQ$SSHQGL[ IURPVFUHHQLQJWKURXJKRXWWKHGXUDWLRQRIVWXG\
WUHDWPHQWDQGIRUGD\VIROORZLQJGLVFRQWLQXDWLRQRIVWXG\GUXJV
H )HPDOHVXEMHFWVZKRXWLOL]HKRUPRQDOFRQWUDFHSWLYHDVRQHRIWKHLUELUWKFRQWUROPHWKRGV
PXVWKDYHXVHGWKHVDPHPHWKRGIRUDWOHDVWWKUHHPRQWKVSULRUWRVWXG\GRVLQJ
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LQ $SSHQGL[  GXULQJKHWHURVH[XDOLQWHUFRXUVHRUEHQRQKHWHURVH[XDOO\DFWLYHRUSUDFWLFH
VH[XDODEVWLQHQFHIURPILUVWGRVHWKURXJKRXWWKHVWXG\SHULRGDQGIRUGD\VIROORZLQJWKH
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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%,)'&
'59579 /39U $79579
1157,
()9(75193539
,167,
'7*5$/
4.3.
Exclusion Criteria
6XEMHFWVZKRPHHWany RIWKHIROORZLQJH[FOXVLRQFULWHULDDUHQRWWREHHQUROOHGLQWKLVVWXG\
 3UHYLRXVXVHRIDQ\DSSURYHGRUH[SHULPHQWDOLQWHJUDVHVWUDQGWUDQVIHULQKLELWRU,167,
IRU DQ\OHQJWKRIWLPHLIWKHFXUUHQWUHJLPHQFRQWDLQVD3,U
 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
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Table 4-2.
Disallowed Agents
Drug Class
Agents Disallowed*
$OSKD$GUHQHUJLF5HFHSWRU$QWDJRQLVWV
$OIX]RVLQ
&DOFLXP&KDQQHO%ORFNHUV
%HSULGLO
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2[FDUED]HSLQH
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6LPYDVWDWLQ/RYDVWDWLQ
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5.
INVESTIGATIONAL MEDICINAL PRODUCTS
5.1.
Randomization, Blinding and Treatment Codes
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WKLUG DQWLUHWURYLUDODJHQW IRUZHHNVIROORZHGE\DGHOD\HGVZLWFKWRIL[HGGRVHUHJLPHQ
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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
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Randomization and baseline visit cannot occur until subject eligibility has been confirmed.
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visit tests and procedures must be completed prior to the administration of the first dose of 
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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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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
Use Discouraged and To Be Used With Caution
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Treatment Assessments
6.4.1.
Treatment Visits (Weeks 4, 8, and 12)
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Treatment Assessments (Week 24)
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Post-treatment Assessments
6.5.1.
Early Study Drug Discontinuation (ESDD) Visit
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Assessments for Premature Discontinuation from Study
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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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6.8.3.
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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7.3.2.
Serious Adverse Events
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Gilead Reporting Requirements
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Special Situations Reports
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Definitions of Special Situations
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Instructions for Reporting Special Situations
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7.6.5.
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
7KHSULPDU\REMHFWLYHRIWKLVVWXG\LV
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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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Laboratory Evaluations
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8.5.4.
Other Safety Evaluations
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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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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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Joint Investigator/Sponsor Responsibilities
9.3.1.
Payment Reporting
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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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IRU+,9LQIHFWLRQDQGH[SDQGHGVXUYHLOODQFHFDVH GHILQLWLRQIRU$,'6DPRQJ
DGROHVFHQWVDQGDGXOWV00:555
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11.
APPENDICES
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Appendix 2.
Study Procedures Table
Study Procedure
Screeninga
Day 1b
End of Weekc
30 Day 
Follow-upe
ESDDf
4
8
12
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GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities
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HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
+HPRJORELQ
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Adult and Pediatric 57 Days
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Grade 2
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Grade 4
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CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
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1 Year
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Infant <1 Year
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Grade 2
Grade 3
Grade 4
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Infant, 7 Days
WRPJG/
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Grade 2
Grade 3
Grade 4
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Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements
1) Definitions
a) Definition of Childbearing Potential
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a) Study Drug Effects on Pregnancy and Hormonal Contraception
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3) Contraception Requirements for Male Subjects
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Appendix 6.
Definitions of HIV-1 Related Disease (CDC Guidelines) {35184}
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