Giving Standardized Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy
Phase: PHASE2
Conditions: HIV I Infection
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

A5403, Version 2.0 Clarification Memo #3 (21Mar2024) 
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ACTG NETWORK COORDINATING CENTER 
DLH 
6720B Rockledge Drive, Suite 777 
Bethesda, MD 20817 
Phone: 301-628-3000 
 
 
 
CLARIFICATION MEMO 
 
DATE:  
March 21, 2024 
 
TO: 
 
ACTG CTU Principal Investigators, CRS Leaders, and CTU/CRS Coordinators 
 
FROM: 
A5403 Protocol Team  
 
SUBJECT: 
Clarification Memo #3 for Protocol A5403, Version 2.0, 30Jun2023, titled “Giving 
Standardized Estradiol Therapy In Transgender Women to Research Interactions 
with HIV Therapy: the GET IT RIgHT Study” 
 
 
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 A5403 study team would like to clarify the inclusion of potential participants who have a 
history of gall bladder disease but have had their gall bladder removed.  
 
The following clarification (noted in bold) to Protocol A5403, Version 2.0, 30Jun2023, titled, 
“Giving Standardized Estradiol Therapy In Transgender Women to Research Interactions with 
HIV Therapy: the GET IT RIgHT Study” will be included in the next version of the A5403 
protocol if it is amended at a future date. 
 
 
1. Exclusion Criterion Section 4.2.10 is being revised as shown below. 
 
Known or a history of gall bladder disease. 
 
NOTE: Persons who have a history of gall bladder disease and have had their 
gallbladder surgically removed are not excluded.