1. VESTED Quiz Game 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

2. What are the primary objectives of VESTED?

3. Primary Objectives To determine:
Whether treatment initiated during pregnancy with a DTG-containing regimen is superior to EFV/FTC/TDF with regard to virologic efficacy at delivery (HIV-1 RNA <200 copies/mL)
Whether rates of the following safety outcomes differ for any pairwise regimen comparison
Adverse pregnancy outcomes
Maternal grade 3 or higher adverse events
Infant grade 3 or higher adverse events

4. Describe the VESTED study design.

5. Study Design VESTED is a: Phase III Multi-site Three-arm
Open-label study

6. How many secondary objectives are there?
Four
Seven
Thirteen
Too many to count
I like this one!

7. Secondary Objectives

8. Describe the randomization
in VESTED.

10. Briefly describe the VESTED
study population.

11. Study Population VESTED will include:
Approximately 549 HIV-1-infected pregnant women initiating antiretroviral therapy at weeks gestation and their infants
From sites in Botswana, Brazil, Haiti, India, Malawi, South Africa, Thailand, Uganda, the United States, Tanzania, and Zimbabwe

12. For how long will each maternal participant take part in the study?
Added “maternal” to the question

13. Participant Follow-Up
Each maternal participant will be followed for ~62-76 weeks
~12-26 weeks during pregnancy
~50 weeks after delivery
Add “maternal” to the first part;

14. How many
mother-infant pairs can be enrolled each month once the study opens to accrual?

16. will enroll the most mother-infant pairs
Which site
will enroll the most mother-infant pairs
in VESTED?

18. List 3 of the
VESTED
inclusion criteria.

19. Inclusion Criteria
See protocol Section 4.1

20. List 3 of the
VESTED
exclusion criteria.

21. Exclusion Criteria
See protocol Section 4.2

22. What is the national animal of Botswana?

23. Mother infant pair!
Ha – I love this!

24. study drugs that mothers in each VESTED arm will receive.
Describe the
study drugs that mothers in each VESTED arm will receive.

25. Arm 1:
DTG+FTC/TAF
Arm 2:
DTG+FTC/TDF
Arm 3:
EFV/FTC/TDF

26. Name a procedure that is required at all scheduled maternal and infant study visits.

27. Procedures Required at All Scheduled Visits
Medical history
Physical examination

28. How is
“ART naïve”
defined in VESTED?

29. Definition of ART Naive
Having not received prior antiretroviral therapy other than ARVs received during prior pregnancies or prior periods of breastfeeding (i.e., receipt of any single, dual, or triple ARV regimen during prior time-limited periods of pregnancy and breastfeeding is permitted).
Receipt of up to 14 days of ARVs during the current pregnancy is permitted prior to study entry so that initiation of ARVs during the current pregnancy is not delayed during the study screening period

30. What maternal
HIV-1 RNA assay
must be used in VESTED?

31. Maternal HIV-1 RNA Assay
Abbott RealTime Viral Load Assay

32. HIV nucleic acid test must be used in VESTED?
What infant
HIV nucleic acid test must be used in VESTED?

33. Infant HIV NAT
Each site must use a test approved by the IMPAACT Laboratory Center for use at the site for diagnosis of infant HIV infection