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 #2 (22Jan2024) 
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ACTG NETWORK COORDINATING CENTER 
DLH 
6720B Rockledge Drive, Suite 777 
Bethesda, MD 20817 
Phone: 301-628-3000 
 
 
 
CLARIFICATION MEMO 
 
DATE:  
January 22, 2024 
 
TO: 
 
ACTG CTU Principal Investigators, CRS Leaders, and CTU/CRS Coordinators 
 
FROM: 
A5403 Protocol Team  
 
SUBJECT: 
Clarification Memo #2 for Protocol A5403, Version 2.0, 30Jun2023, Entitled, 
“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 CMs 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 clarifications contained in this memo should be implemented immediately.  
 
Sex/Gender for Laboratory Reference Ranges 
For participants completing screening/entry evaluations, sites should use sex assigned at birth 
for reference laboratory ranges and CrCl estimation. For post-entry evaluations, sites should 
use female reference laboratory ranges and CrCl estimation for adverse event grading. 
 
Transdermal Estrogen 
For participants receiving transdermal estrogen prior to entry, the protocol team suggests that 
the sites follow the guidance associated with oral estrogen, and that participants should be off 
transdermal estrogen for at least 14 days prior to entry. There is no change to exclusion 
criterion 4.2.6 as the participant will not be receiving either oral or injectable estrogens.