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 #1 (17Jan2024) 
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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 17, 2024 
 
TO: 
 
ACTG CTU Principal Investigators, CRS Leaders, and CTU/CRS Coordinators 
 
FROM: 
A5403 Protocol Team  
 
SUBJECT: 
Clarification Memo #1 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 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(s) contained in this memo should be implemented immediately.  
 
The A5403 study team would like to correct a typo in the protocol inclusion criteria for Prolactin.  
 
The following clarification (noted in bold or strikethrough) 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.” These clarifications will be included in 
the next version of the A5403 protocol if it is amended at a future date. 
 
 
1. In section 4.1.9, Inclusion Criteria, the last bullet point is being revised as shown below. 
 
The following laboratory values obtained within 60 days prior to study entry by any US 
laboratory that has a CLIA certification or its equivalent, or at any network-approved non-US 
laboratory that operates in accordance with GCLP and participates in appropriate external 
quality assurance programs. 
• 
Hemoglobin ≥9.0 g/dL 
• 
Platelet count ≥75,000/mm3 
• 
Estimated Glomerular Filtration Rate (eGFR) ≥30 mL/min/1.73m2 if on or switching to 
TAF, ≥50 mL/min/1.73m2 if on or switching to TDF without cobicistat, or ≥70 
mL/min/1.73m2 if on or switching to TDF in combination with cobicistat, calculated using 

A5403, Version 2.0 Clarification Memo #1 (17Jan2024) 
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the CKD-Epi equation (a calculator is available at: 
https://qxmd.com/calculate/calculator_251/egfr-using-ckd-epi). 
• 
Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), 
and alkaline phosphatase are within normal range per local laboratory range 
• 
Prolactin <25 ng/dmL