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VESTED Quiz Game

VESTED Quiz Game. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. What are the primary objectives of VESTED?. Primary Objectives. To determine:

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VESTED Quiz Game

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

  6. How many secondary objectives are there? • Four • Seven • Thirteen • Too many to count

  7. Secondary Objectives

  8. Describe the randomization in VESTED.

  9. Briefly describe the VESTED study population.

  10. Study Population VESTED will include: • Approximately 549 HIV-1-infected pregnant women initiating antiretroviral therapy at 14-28 weeks gestation and their infants • From sites in Botswana, Brazil, Haiti, India, Malawi, South Africa, Thailand, Uganda, the United States, Tanzania, and Zimbabwe

  11. For how long will each maternal participant take part in the study?

  12. Participant Follow-Up Each maternal participant will be followed for ~62-76 weeks • ~12-26 weeks during pregnancy • ~50 weeks after delivery

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

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

  15. List 3 of the VESTED inclusion criteria.

  16. Inclusion Criteria See protocol Section 4.1

  17. List 3 of the VESTED exclusion criteria.

  18. Exclusion Criteria See protocol Section 4.2

  19. What is the national animal of Botswana?

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

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

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

  23. Procedures Required at All Scheduled Visits • Medical history • Physical examination

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

  25. 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

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

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

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

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

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