A Phase I, First-in-Human Study of SAR441236, a Tri-specific Broadly Neutralizing Antibody, in Participants With HIV
Phase: PHASE1
Conditions: HIV-1-infection
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

A5377, Version 4.0  
Clarification Memo #1 (22Sep2022) 
Page 1 of 2 
 
ACTG NETWORK COORDINATING CENTER 
Social & Scientific Systems, Inc., a DLH Holdings Company 
8757 Georgia Avenue, 12th Floor 
Silver Spring, MD  20910-3714 
Phone: 301-628-3000 
 
 
 
CLARIFICATION MEMO #1 
 
DATE:  
22 September 2022 
 
TO: 
 
ACTG CTU Principal Investigators, CRS Leaders, and CTU/CRS Coordinators 
 
FROM: 
A5377 Protocol Team  
 
SUBJECT: 
Clarification Memo #1 for Protocol A5377, Version 4.0 
 
 
This clarification memo (CM) does not result in a change in the protocol informed 
consent document. The Division of AIDS does not require you to forward it to your 
institutional review board (IRB); however, you must follow your IRB's policies and 
procedures. If IRB review of clarification memos is required at your site, please submit 
this document for review. 
 
Each site should file a copy of this CM with the protocol for reference. 
 
The protocol clarification contained in this memo should be implemented immediately.  
 
The purposes of this CM are to update the study roster and to clarify that evaluable Arm B 
Cohort 8 participants are required to have an entry HIV-1 RNA level of at least 5000 copies/mL.  
 
1. The following are updates to the study’s title page and roster: 
A. Title page: 
Clinical Trial Specialist:  
Evelyn Hogg, BA Chanelle Wimbish, BS, CCRP 
 
B. Team Roster: 
Clinical Trials Specialist 
Evelyn Hogg, BA 
ACTG Network Coordinating Center 
Social & Scientific Systems, Inc., A DLH Holdings Company 
8757 Georgia Avenue, 12th Floor 
Silver Spring, MD 20910-3714 
Phone: 301-628-3337 
E-mail: evelyn.hogg@dlhcorp.com 
 
Chanelle Wimbish, BS, CCRP 
ACTG Network Coordinating Center 
Social & Scientific Systems, Inc., A DLH Holdings Company 

A5377, Version 4.0  
Clarification Memo #1 (22Sep2022) 
Page 2 of 2 
 
8757 Georgia Avenue, 12th Floor 
Silver Spring, MD 20910-3714 
Phone: 301-628-3367 
E-mail: chanelle.wimbish@dlhcorp.com 
 
Laboratory Data Manager 
Kacey Matecki, BS 
Frontier Science and Technology Research Foundation 
4033 Maple Road 
Amherst, NY 14226 
Phone: 716-834-0900 
E-mail: Matecki@frontierscience.org 
 
Kevin Knowles, PhD 
Frontier Science and Technology Research Foundation 
4033 Maple Road 
Amherst, NY 14226 
Phone: 716-834-0900 
E-mail: knowles@frontierscience.org 
 
 
2. The following clarification applies to the third sentence of the second paragraph in 
section 10.4, Sample Size and Accrual. In that sentence, a typographical error occurs; 
this sentence should read as shown below, for consistency with eligibility criteria 4.2.10 
and 4.2.11. 
 
“Arm B participants who discontinue the study prior to Day 14 without sufficient virology 
data (as judged by the CST), or beginning with Version 4.0 of the protocol, who have an 
entry plasma HIV-1 RNA <50 <5000 copies/mL, will be replaced to ensure enough 
efficacy data are available for dose de-escalation evaluation.” 
 
These clarifications will be included in the next version of the A5377 protocol if it is amended at 
a future date.