A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification With Maraviroc and Dolutegravir With No Intensification or Intensification With Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV
Phase: PHASE4
Conditions: HIV Infections
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

 
 
 
A5324, Version 2.0 LOA #3 (08/22/18) 
IND Number: 126,854 
 
 
Page 1 of 3 
 
ACTG Network Coordinating Center 
Social & Scientific Systems, Inc. 
 
 
 
 
Telephone: 301-628-3000 
8757 Georgia Avenue, 12th Floor 
 
 
 
 
Fax: 
301-628-3302 
Silver Spring, MD  20910 
 
 
LETTER OF AMENDMENT 
 
 
DATE:  
August 22, 2018 
 
TO: 
 
ACTG CTU Principal Investigators, CRS Leaders, and CTU/CRS Coordinators 
 
FROM: 
A5324 Protocol Team  
 
SUBJECT: 
Letter of Amendment #3 for Protocol A5324, Version 2.0, 08/25/17, entitled “A 
Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral 
Intensification with Maraviroc and Dolutegravir with No Intensification or 
Intensification with Dolutegravir Alone for the Treatment of Cognitive Impairment 
in HIV” 
 
 
The following information impacts the A5324 study and must be forwarded to your 
institutional review board (IRB)/ethics committee (EC) as soon as possible for their 
information and review. 
 
The following information also impacts the Sample Informed Consent. Your IRB/EC is 
responsible for determining the process of informing participants of the contents of this 
LOA.   
 
Sites are still required to submit an LOA registration packet to the Division of AIDS 
(DAIDS) Protocol Registration Office (PRO) at the Regulatory Support Center. Sites will 
receive a registration notification for the LOA once the DAIDS PRO verifies that all 
required LOA registration documents have been received and are complete. An LOA 
registration notification from the DAIDS PRO is not required prior to implementing the 
LOA. A copy of the LOA registration notification, along with this letter and any IRB/EC 
correspondence, should be retained in the site’s regulatory files. 
 
The main reason for this LOA is to correct discrepancies in the Sample Informed 
Consent about pregnancy testing after study entry to be consistent with the pregnancy 
testing requirement that was updated through LOA #2. The corrections made to A5324, 
Version 2.0, 08/25/17, Sample Informed Consent, are explained below. 
 

 
 
 
A5324, Version 2.0 LOA #3 (08/22/18) 
IND Number: 126,854 
 
 
Page 2 of 3 
 
1. Appendix I, Sample Informed Consent, WHAT DO I HAVE TO DO IF I AM IN THIS 
STUDY?: 
 
In the After Entry sub-section, seventh bullet, the following changes have been made: 
 
• 
If you are a woman and you think you might be who can become pregnant, you will 
have a pregnancy test at every study visit. You will be told the result of this test 
when it becomes available. 
 
In the If You Have to Stop Taking the Study Drugs Early or You Have to Stop the Study 
Early sub-section, fifth bullet, the following changes have been made: 
 
• 
If you are a woman and you think you might be who can become pregnant, you will 
have a pregnancy test. We will tell you the test result when it becomes available. 
 
2. Per a new regulatory requirement by DAIDS, a Protocol Signature Page (PSP) is appended 
for submission to DAIDS Protocol Registration System (DPRS) as part of the LOA 
registration packet. 
 
The information above will be incorporated into the next protocol version as necessary if the 
protocol is amended. 

 
 
 
A5324, Version 2.0 LOA #3 (08/22/18) 
IND Number: 126,854 
 
 
Page 3 of 3 
 
 
 
A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral 
Intensification with Maraviroc and Dolutegravir with No Intensification or Intensification 
with Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV 
Version 2.0, 08/25/17 
 
 
SIGNATURE PAGE 
 
 
I will conduct the study in accordance with the provisions of this protocol and all applicable 
protocol-related documents. I agree to conduct this study in compliance with United States (US) 
Health and Human Service regulations (45 CFR 46); applicable U.S. Food and Drug 
Administration regulations; standards of the International Conference on Harmonization 
Guideline for Good Clinical Practice (E6); Institutional Review Board/Ethics Committee 
determinations; all applicable in-country, state, and local laws and regulations; and other 
applicable requirements (e.g., US National Institutes of Health, Division of AIDS) and 
institutional policies. 
 
 
 
 
 
Principal Investigator: _____________________________________________________ 
 
Print/Type 
 
 
 
 
 
Signed: _______________________________________________Date: _____________ 
 
Name/Title