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)

Clarification Memorandum #1       
Page 1 of 2 
26 April 2018 
IMPAACT 2008 Protocol Version 2.0 
Clarification Memorandum # 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 
 
Clarification Memorandum Date: 26 April 2018   
 
 
Summary of Clarifications and Rationale 
 
This Clarification Memorandum (CM) clarifies that the current version of the Division of AIDS Table for 
Grading the Severity of Adult and Pediatric Adverse Events should be used to grade adverse events. In 
addition, this CM corrects a typographical error: “malnutrition” had inadvertently been retained in 
protocol Section 7.3.3 due to a cut-and-paste error; malnutrition is now removed from this listing.  
 
 
Implementation 
 
This CM has been approved by the NIAID and NICHD Medical Officers. Institutional Review 
Board/Ethics Committee (IRB/EC) approval of this CM is not required by the study sponsor prior to 
implementation. However, sites may submit this CM to the responsible IRBs/ECs for their information or, 
if required by the IRBs/ECs, for their approval prior to implementation. 
 
The content of the CM does not impact the sample informed consent forms for the study or the benefit-to-
risk ratio for study participants. This CM should be maintained in each site’s essential documents file for 
IMPAACT 2008. It is the responsibility of the Investigator of Record to ensure that all study staff are 
made aware of this CM. 
 
The modifications included in this CM are listed below in order of appearance in the protocol and will be 
incorporated into the next protocol amendment as specified below. Additions to the text are indicated in 
bold; deletions are indicated by strike-through.   
 
 

Clarification Memorandum #1       
Page 2 of 2 
26 April 2018 
IMPAACT 2008 Protocol Version 2.0 
1. Protocol Section 7.3.3 is updated to specify use of the current Division of AIDS Table for Grading the 
Severity of Adult and Pediatric Adverse Events and to correct a typographical error, as follows: 
 
For infants in both study arms, adverse events will be graded according to the Division of AIDS 
Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), 
Corrected Version 2.1, dated March July 2017, which is available on the RSC website:   
http://rsc.tech-res.com/clinical-research-sites/safety-reporting/daids-grading-tables 
 
The only exceptions to the above apply to grading of axillary measured fever, and injection site 
pain/tenderness, and malnutrition, which will be graded as follows […] [see protocol Section 7.3.3]