Phase I/II Multisite, Randomized, Controlled Study of Monoclonal Antibody VRC01 With Combination Antiretroviral Therapy to Promote Clearance of HIV-1-Infected Cells in Infants
Phase: PHASE1
Conditions: HIV Infections
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Letter of Amendment #1       
Page 1 of 12 
14 June 2018 
IMPAACT 2008 Protocol Version 2.0 
Letter of Amendment #1 for: 
 
IMPAACT 2008 
Phase I/II Multisite, Randomized, Controlled Study of Monoclonal Antibody VRC01 
with Combination Antiretroviral Therapy  
to Promote Clearance of HIV-1-Infected Cells in Infants 
 
Version 2.0, dated 29 May 2017 
 
 DAIDS ES # 20735 
IND # 133,017 Held By DAIDS 
 
Letter of Amendment Date: 14 June 2018 
 
 
 
Table of Contents 
 
Information/Instructions to Study Sites from the Division of AIDS ............................................................ 1 
Letter of Amendment Signature Page ........................................................................................................... 2 
Summary of Modifications and Rationale .................................................................................................... 3 
Implementation ............................................................................................................................................. 3 
 
 
 
Information/Instructions to Study Sites from the Division of AIDS 
 
The information contained in this Letter of Amendment (LoA) affects the IMPAACT 2008 study, 
including the study informed consent forms, and must be submitted to site Institutional Review Boards 
(IRBs) and/or Ethics Committees (ECs) as soon as possible for their review and approval. Approval must 
also be obtained from site regulatory entities if applicable per the policies and procedures of the 
regulatory entities. All IRB/EC and regulatory entity requirements must be followed. 
 
Upon obtaining all required IRB/EC approvals and any other applicable regulatory entity approvals, each 
site should immediately begin implementing this LoA, using site-specific informed consent forms 
corresponding to this LoA. For participants enrolled in the study before this LoA is approved, re-consent 
should be obtained using site-specific informed consent forms corresponding to this LoA. 
 
Upon receiving IRB/EC approvals and any other applicable regulatory entity approvals, sites are required 
to submit an LoA registration packet to the DAIDS Protocol Registration Office (DAIDS PRO) at the 
Regulatory Support Center (RSC). Sites will receive a registration notification for the LoA after the 
DAIDS PRO verifies that all required registration documents have been received and are complete. Sites 
should not await this notification before implementing this LoA.  
 
Please file this LoA, corresponding site-specific informed consent forms, all associated IRB/EC and 
regulatory entity correspondence, and all correspondence with the DAIDS PRO in your essential 
documents files for IMPAACT 2008. If the IMPAACT 2008 protocol is amended in the future, the 
contents of this LoA will be incorporated into the next version of the protocol. 
 

Letter of Amendment #1       
Page 2 of 12 
14 June 2018 
IMPAACT 2008 Protocol Version 2.0 
IMPAACT 2008 
Phase I/II Multisite, Randomized, Controlled Study of 
Monoclonal Antibody VRC01 with Combination Antiretroviral Therapy 
to Promote Clearance of HIV-1-Infected Cells in Infants 
 
DAIDS Study ID #20735 
 
 
Version 2.0, Letter of Amendment #1 
Letter of Amendment Signature Page 
 
 
I will conduct this study in accordance with the provisions of this protocol and all applicable protocol-
related documents. I agree to conduct this study in compliance with United States (US) Health and 
Human Service regulations (45 CFR 46); applicable US Food and Drug Administration regulations; 
standards of the International Conference on Harmonization Guideline for Good Clinical Practice (E6); 
Institutional Review Board/Ethics Committee determinations; all applicable in-country, state, and local 
laws and regulations; and other applicable requirements (e.g., US National Institutes of Health, Division 
of AIDS) and institutional policies. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Investigator of Record 
  
 
Date 
 
 
 
 
 
 
 
 
 
 
Name of Investigator of Record  
 
(printed) 
 
 

Letter of Amendment #1       
Page 3 of 12 
14 June 2018 
IMPAACT 2008 Protocol Version 2.0 
Summary of Modifications and Rationale 
 
The purpose of this LoA is to: 
 
• 
Update the protocol team and study site rosters 
• 
Provide operational flexibility for conducting the Week 14 and Week 16 study visits, at which 
specimens are collected for primary antiviral activity analyses and secondary pharmacokinetics 
analyses, respectively 
• 
Update the protocol and sample informed consent forms consistent with International Conference on 
Harmonization (ICH) Good Clinical Practice (GCP) standards and current DAIDS requirements 
pertaining to review of study records 
• 
Correct internal inconsistencies and procedural inaccuracies in the protocol  
 
 
Implementation 
 
Modifications of protocol text are shown below, generally in order of appearance in the protocol. Where 
applicable, modified protocol text is shown using strikethrough for deletions and bold type for additions.  
 
1. The protocol team roster is updated to replace a Protocol Statistician and remove two Protocol Data 
Managers: 
 
Protocol Statisticians 
Konstantia (Nadia) Angelidou, MS  
Jane Lindsey, ScD 
Center for Biostatistics in AIDS Research 
Harvard TH Chan School of Public Health 
651 Huntington Avenue 
Boston, MA 02115 
Phone: (617) 432-2524 
Email: kangelid@sdac.harvard.edu 
Phone: (617) 432-2812 
Email: lindsey@sdac.harvard.edu 
 
Protocol Data Managers  
Amanda Golner, BS  
Frontier Science & Technology Research Foundation (FSTRF)  
4033 Maple Road  
Amherst, NY 14226-1056  
Phone: (716) 834-0900 x7382  
Email: golner@fstrf.org 
 
Jenna Kearly, MPH 
Frontier Science & Technology Research Foundation (FSTRF)  
4033 Maple Road  
Amherst, NY 14226-1056  
Phone: (716) 834-0900 x7249  
Email: kearly.jenna@fstrf.org 

Letter of Amendment #1       
Page 4 of 12 
14 June 2018 
IMPAACT 2008 Protocol Version 2.0 
2. The study site roster is updated to remove two sites and update contact details for three sites: 
 
Site 5011, Boston Medical Center 
Ellen Cooper, MD 
Boston Medical Center 
Division of Pediatric Infectious Diseases 
670 Albany St., Rm. 623 
Boston, MA 02118 
Phone: (671) 414-5588 
Email: ercooper@bu.edu 
 
Site 5030, Emory University School of Medicine  
Ann Chahroudi, MD, PhD  
Division of Pediatrics Infectious Diseases  
Emory University School of Medicine  
E472 HSRB  
1760 Haygood Dr.  
Atlanta, GA 30322-1119  
Phone: (404) 727-9209  
Email: achahro@emory.edu 
 
Site 5055, South Florida CDTC Ft. Lauderdale 
Ana M. Puga, MD, FAAP Lisa-Gaye Robinson, MD, MPH 
Children’s Diagnostic & Treatment Center, Inc. 
1401 South Federal Highway 
Fort Lauderdale, Florida 33316 
Phone: (954) 728-1017 (954) 728-1136 
Email: apuga@browardhealth.org lerobinson@browardhealth.org 
 
Site 30301, Johns Hopkins University Blantyre Clinical Research Site 
Luis Gadama, MBBS FCOG Macpherson Mallewa, MRCPCH, PhD, DTM&H 
College of Medicine-Johns Hopkins Research Project 
PO Box 1131 
Blantyre, Malawi 
Phone: +265 1 875 129 
Email: Lgadama@jhu.medcol.mw mmallewa@mlw.medcol.mw  
 
Site 31890, Harare Family Care  
Tapiwa Grace Mbengeranwa MBChB  
UZ-UCSF University of Zimbabwe College of Health Sciences – Clinical Trials Unit  
(UZCHS-CTU) 
15 Phillips Avenue  
Belgravia  
Harare, Zimbabwe  
Email: tgmbenge@uzcrc.co.zw 
 

Letter of Amendment #1       
Page 5 of 12 
14 June 2018 
IMPAACT 2008 Protocol Version 2.0 
3. Protocol Sections 6.2, 6.6, 6.9, 6.11, and 6.13 are updated to specify correct specimen types for HIV-
1-specific antibody-dependent cellular cytotoxicity (ADCC) and virus neutralization assays. ADCC 
assays will be performed with serum; neutralization assays will be performed with plasma; as such, 
bullet points in the infant Laboratory/Blood row of the procedural tables in these sections are 
corrected as follows:   
 
• Stored serum for ADCC neutralization assay 
 
The correct specimen types are also incorporated into the Schedule of Evaluations, as shown on the 
last five pages of this LoA, and into Section 6.17.1, as follows: 
 
In the event that blood collection must be limited, available specimens should be prioritized for use in 
the following order: (1) hematology, (2) chemistry, (3) HIV RNA, (4) CD4 and CD8 cell count 
and percentage, (5) stored PBMCs and plasma for primary evaluations, (6) stored serum for ADCC 
neutralizing assays, (7) stored plasma and PBMCs for exploratory evaluations. 
 
4. Protocol Sections 6.6 and 6.7 are updated to modify the allowable visit windows for the Week 14 and 
Week 16 Visits, as follows: 
 
Section 6.6 
The Week 14 Visit is targeted to take place on Day 98, counted from the date of randomization as 
Day 0, with an allowable a preferred window of ± 7 days and an allowable window of -7 to +14 
days. In addition to other routine study procedures, blood is collected and stored at this visit for 
primary antiviral activity evaluations. Therefore, every effort should be made to conduct this visit 
as close as possible to the target date and within the preferred window. If the visit cannot be 
conducted within the preferred window, the visit may be conducted within the allowable 
window with approval in advance from the CMC. Please contact the CMC as soon as possible 
upon awareness of any visit that may not be conducted within the preferred window.    
 
Note: The Week 14 and Week 16 allowable visit windows overlap by a period of seven days. The 
Week 14 Visit should preferably be conducted before this period of overlap. However, if this is 
not possible, the Week 14 Visit may be conducted during the period of overlap and, in this case, 
the Week 14 and Week 16 Visits may be combined (i.e., all Week 14 and Week 16 visit 
procedures may be performed on one day).  
 
There is no required sequencing of procedures at this visit. 
 
Week 14 Visit Procedures (Day 98 ± 7 days)  
(Day 98 ± 7 days preferred; Day 98 -7 to +14 days allowed) 
 
Section 6.7 
The Week 16 Visit is targeted to take place on Day 112, counted from the date of randomization as 
Day 0, with an allowable window of ± 7 -7 to +14 days. There is no required sequencing of 
procedures at this visit. 
 
Week 16 Visit Procedures (Day 112 ± 7 -7 to +14 days) 
 
These updates are also incorporated into the Schedule of Evaluations as shown on the last five pages 
of this LoA (Week 14 and Week 16 visit windows updated; footnote 9 added).  
 

Letter of Amendment #1       
Page 6 of 12 
14 June 2018 
IMPAACT 2008 Protocol Version 2.0 
5. Protocol Section 6.14 is updated to correct an internal inconsistency. For consistency with other sub-
sections within Section 6 and the Schedule of Evaluations, Section 6.14 is corrected as follows: 
 
ARV History  
Infant ARV history is collected at the Screening Visit and updated as needed at each scheduled visit 
the Entry Visit and at scheduled follow-up visits as indicated in Section 6 and the Schedule of 
Evaluations. [paragraph continues] 
 
6. In the protocol Table of Contents and Section 8.2, the section title is updated; also in Section 8.2, the 
fifth paragraph is corrected, as follows: 
8.2 
Deferral of Study Product Administration for Adverse Event and Toxicity Management and 
Resolution 
 
Fifth paragraph 
Following required consultation with the CMC, and improvement or resolution of the 
exclusionary condition (if applicable), study product may be administered. Whenever possible, 
infants should be re-scheduled to return to the clinic for product administration within the 
allowable visit window. If the allowable window elapses before adverse event and toxicity 
management requirements are met, the site investigator should consult with the CMC, which 
may approve product administration after the allowable window. 
 
7. Protocol Section 11.2 and the sample informed consent forms in Appendices II-V are updated to 
reflect ICH GCP E6 4.8.10(n) and current DAIDS requirements pertaining to review of study records, 
as follows: 
 
Section 11.2, fourth paragraph, first sentence 
All study records must be accessible for inspection, monitoring, and/or auditing during and after the 
conduct of the study by authorized representatives of the study sponsors and their contracted 
monitors, IMPAACT, the VRC, the US Food and Drug Administration, site drug regulatory 
authorities, site IRBs/ECs, OHRP, and other applicable US, local, and international regulatory 
entities.  
 
Appendix II, item 22, and Appendix III, item 9 
Groups that oversee the study include:  
 
• 
[insert name of site IRBs/ECs] 
• 
[insert name of site drug regulatory authority] 
• 
[insert name of other site drug entities that may review records] 
• 
The United States National Institutes of Health and its study monitors 
• 
The United States Food and Drug Administration 
• 
The United States Office for Human Research Protections 
• 
The IMPAACT Network that is coordinating the study 
• 
Other US, local, and international regulatory entities 
 
 
 

Letter of Amendment #1       
Page 7 of 12 
14 June 2018 
IMPAACT 2008 Protocol Version 2.0 
Appendix IV, item 7, and Appendix V, item 7 
These groups include:  
 
• 
The IMPAACT Network  
• 
The ethics committees that review and approve the research  
• 
Government and other agencies that pay for the research  
• 
Government and other agencies that monitor the research  
• 
Other US, local, and international regulatory entities 
 

 
Letter of Amendment #1       
Page 8 of 12 
14 June 2018 
IMPAACT 2008 Protocol Version 2.0 
Appendix I 
IMPAACT 2008 Schedule of Evaluations:  Screening through Week 14 
Study Visit 
Screen 
Entry 
Entry  
+3d 
Week 
1 
Week 
2 
Week 
2+3d 
Week 
3 
Week 
6 
Week 
6+3d 
Week 
7 
Week 
10 
Week 
10+3d 
Week 
11 
Week 
149 
Visit Window 
-30 d 
Day 0 
-1/+3 d 
±3 d 
±3 d 
-1/+3 d 
±3 d 
±7 d 
-1/+3 d 
±3 d 
±7 d 
-1/+3 d 
±3 d 
-7/+14 d 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Maternal Evaluations (for mothers of enrolled infants who consent to blood collection) 
 
 
 
 
 
 
 
Stored plasma and PBMCs 
for exploratory evaluations 
 
10 mL 
 
 
 
 
 
 
 
 
 
 
 
 
Stored serum for 
exploratory evaluations 
 
10 mL 
 
 
 
 
 
 
 
 
 
 
 
 
Infant Evaluations 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HIV-related testing history 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Medical/medications history 
X 
X 
 
X 
X 
 
X 
X 
 
X 
X 
 
X 
X 
ARV history 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Immunization history 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Feeding history 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
cART adherence assessment 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Physical examination 
X 
X 
 
X 
X 
 
X 
X 
 
X 
X 
 
X 
X 
VRC01 administration1 
(Arm 1 only) 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
 
Reactogenicity assessment2 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Confirmatory HIV nucleic 
acid test (if needed) 
0-3 mL 
 
 
 
 
 
 
 
 
 
 
 
 
 
Complete blood count with 
differential and platelets 
1 mL 
 
 
1 mL 
 
 
1 mL 
 
 
1 mL 
 
 
1 mL 
1 mL 
ALT, AST, ALP, creatinine 
1 mL 
 
 
1 mL 
 
 
1 mL 
 
 
1 mL 
 
 
1 mL 
1 mL 
CD4 and CD8 cell count 
and percentage3 
1 mL 
 
 
 
 
 
 
 
 
 
 
 
 
1 mL 
HIV-1 RNA in plasma4 
(real time) 
 
1 mL4 
 
3 mL4 
 
 
 
3 mL4 
 
 
3 mL4 
 
 
3 mL4 
Urinalysis 
 
X 
 
X 
 
 
 
 
 
 
 
 
 
X 

 
Letter of Amendment #1       
Page 9 of 12 
14 June 2018 
IMPAACT 2008 Protocol Version 2.0 
Appendix I 
IMPAACT 2008 Schedule of Evaluations:  Screening through Week 14 
Study Visit 
Screen 
Entry 
Entry  
+3d 
Week 
1 
Week 
2 
Week 
2+3d 
Week 
3 
Week 
6 
Week 
6+3d 
Week 
7 
Week 
10 
Week 
10+3d 
Week 
11 
Week 
149 
Visit Window 
-30 d 
Day 0 
-1/+3 d 
±3 d 
±3 d 
-1/+3 d 
±3 d 
±7 d 
-1/+3 d 
±3 d 
±7 d 
-1/+3 d 
±3 d 
-7/+14 d 
Infant Evaluations (continued) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stored plasma and PBMCs 
for primary, secondary, and 
other evaluations 
 
3-5 mL5 
 
 
1 mL 
 
 
1 mL 
 
 
1 mL 
 
 
5 mL 
VRC01 resistance 
(plasma) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
VRC01 level  
(plasma) 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Anti-VRC01 antibodies 
(plasma) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
HIV-1 DNA  
(PBMC) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
HIV-1 RNA (spliced/ 
unspliced; PBMC) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
HIV-1 RNA (inducible; 
PBMC) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Neutralization  
(plasma) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
ARV levels  
(plasma, adherence) 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Stored serum for  
ADCC 
 
1 mL 
 
 
 
 
 
 
 
 
 
 
 
1 mL 
Stored plasma and PBMCs 
for exploratory evaluations6 
 
0-2 mL6 
 
 
X6 
 
 
X6 
 
 
X6 
 
 
0-2 mL6 
Cerebral spinal fluid storage 
for exploratory evaluations 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total Infant Blood Volume 
3-6 mL 
5-9 mL 
— 
5 mL 
1 mL 
— 
2 mL 
4 mL 
— 
2 mL 
4 mL 
— 
2 mL 
12-14 
mL 
 
 
 

 
Letter of Amendment #1       
Page 10 of 12 
14 June 2018 
IMPAACT 2008 Protocol Version 2.0 
 
Appendix I 
IMPAACT 2008 Schedule of Evaluations:  Week 16 through Week 48 
Study Visit 
Week  
169 
Week  
20 
Week  
24 
Week  
36 
Week  
48 
Early  
D/C7 
CSF 
Collection8 
Visit Window 
-7 to +14 d 
±14 d 
±14 d 
±14 d 
±14 d 
NA 
NA 
Informed consent 
 
 
 
 
 
 
 
 
Maternal Evaluations (for mothers of enrolled infants who consent to specimen collection) 
Stored plasma and PBMCs 
for exploratory evaluations 
 
 
 
 
 
 
 
Stored serum for 
exploratory evaluations 
 
 
 
 
 
 
 
Infant Evaluations 
 
 
 
 
 
 
 
HIV-related testing history 
 
 
 
 
 
 
 
Medical/medications history 
X 
X 
X 
X 
X 
X 
X8 
ARV history 
X 
X 
X 
X 
X 
X 
 
Immunization history 
X 
X 
X 
X 
X 
X 
 
Feeding history 
X 
X 
X 
X 
X 
X 
 
cART adherence assessment 
X 
X 
X 
X 
X 
X 
 
Physical examination 
X 
X 
X 
X 
X 
X 
 
VRC01 administration 
(Arm 1 only) 
 
 
 
 
 
 
 
Reactogenicity assessment 
 
 
 
 
 
 
 
Confirmatory HIV nucleic 
acid test (if needed) 
 
 
 
 
 
 
 
Complete blood count with 
differential and platelets 
 
1 mL 
1 mL 
0-1 mL3 
0-1 mL3 
1 mL7 
 
ALT, AST, ALP, creatinine 
 
1 mL 
1 mL 
 
 
 
 
CD4 and CD8 cell count 
and percentage3 
 
 
1 mL 
1 mL3 
1 mL3 
1 mL7 
 
HIV-1 RNA in plasma4 
(real time) 
3 mL4 
 
3 mL4 
3 mL4 
3 mL4 
3 mL4,7 
 
Urinalysis 
 
 
X 
 
 
[X]7 
 

 
Letter of Amendment #1       
Page 11 of 12 
14 June 2018 
IMPAACT 2008 Protocol Version 2.0 
 
Appendix I 
IMPAACT 2008 Schedule of Evaluations:  Week 16 through Week 48 
Study Visit 
Week  
169 
Week  
20 
Week  
24 
Week  
36 
Week  
48 
Early  
D/C7 
CSF 
Collection8 
Visit Window 
-7 to +14 d 
±14 d 
±14 d 
±14 d 
±14 d 
NA 
NA 
Infant Evaluations (continued) 
 
 
 
 
 
 
Stored plasma and PBMCs 
for primary, secondary, and 
other evaluations 
1 mL 
 
7 mL 
 
7 mL 
5-7 mL7 
 
VRC01 resistance 
(plasma) 
 
 
 
 
 
 
 
VRC01 level  
(plasma) 
X 
 
 
 
 
X 
 
Anti-VRC01 antibodies 
(plasma) 
 
 
X 
 
X 
X 
 
HIV-1 DNA  
(PBMC) 
 
 
X 
 
X 
X 
 
HIV-1 RNA (spliced/ 
unspliced; PBMC) 
 
 
X 
 
X 
X 
 
HIV-1 RNA (inducible; 
PBMC) 
 
 
X 
 
X 
 
 
Neutralization  
(plasma) 
 
 
X 
 
X 
X 
 
ARV levels  
(plasma, adherence) 
 
 
X 
 
X 
X 
 
Stored serum for  
ADCC 
 
 
1 mL 
 
1 mL 
1 mL7 
 
Stored plasma and PBMCs 
for exploratory evaluations6 
X6 
 
2 mL 
5 mL 
7 mL 
2 mL7 
2 mL8 
Cerebral spinal fluid storage 
for exploratory evaluations 
 
 
 
 
 
 
X8 
Total Infant Blood Volume 
4 mL 
2 mL 
16 mL 
9-10 mL 
19-20 mL 
13-15 mL 
2 mL 
 
 
 
 

 
Letter of Amendment #1       
Page 12 of 12 
14 June 2018 
IMPAACT 2008 Protocol Version 2.0 
Appendix I Footnotes 
 
1. At Entry and Weeks 2, 6, and 10, for infants in Arm 1, blood collection must precede administration of VRC01. 
2. Refer to Section 6.16. 
3. CD4 and CD8 cell counts and percentages are generally expected to require 1 mL of blood. At sites where a complete blood count (CBC) is needed 
to obtain both cell counts and percentages, 1 mL may be collected to perform the CBC at Week 36 and Week 48 (at other sites, the CBC is not 
required at these visits). 
4. At Entry, collect 1 mL and dilute as needed to perform the HIV-1 RNA assay. At all other time points, collect 3 mL and process specimen for 
storage of PBMCs in addition to plasma for the RNA assay, if possible. 
5. At Entry, collect 3 mL for storage for primary, secondary, and other evaluations if the infant weighs <3 kg; collect 5 mL if the infant weighs ≥3 
kg. 
6. At Entry and Week 14, collect 2 mL for storage for exploratory evaluations only if the infant weighs ≥ 3 kg at the visit; otherwise, do not 
collect any blood for exploratory evaluations at these visits. At Weeks 2, 6, 10, and 16, no additional blood is collected for exploratory 
evaluations but any plasma and PBMCs remaining from specimens collected for primary, secondary, and other evaluations will be stored for 
exploratory purposes (indicated with “X6”).  
7. Refer to Section 6.13. Infants who are withdrawn or terminated before completing the Week 24 Visit should have urinalysis performed and 5 mL 
of blood drawn for storage for primary, secondary, and other evaluations; infants who are withdrawn or terminated after the Week 24 Visit 
should not have urinalysis performed and should have 7 mL of blood drawn for storage for primary, secondary, and other evaluations. For all 
infants, laboratory evaluations that have been performed within the two weeks prior to the Early D/C Visit need not be repeated. 
8. Refer to Section 6.12.  
9. The Week 14 Visit is targeted to take place on Day 98, with a preferred window of ±7 days and an allowable window of -7 to +14 days. 
Every effort should be made to conduct this visit as close as possible to the target date and within the preferred window. If the visit cannot 
be conducted within the preferred window, the visit may be conducted within the allowable window with approval in advance from the 
CMC. Also note that the Week 14 and Week 16 allowable visit windows overlap by a period of seven days. The Week 14 Visit should 
preferably be conducted before this period of overlap. However, if this is not possible, the Week 14 Visit may be conducted during the 
period of overlap and, in this case, the Week 14 and Week 16 Visits may be combined (i.e., all Week 14 and Week 16 visit procedures may 
be performed on one day)