Antepartum Evaluations: Key Concepts and Protocol Specifications

1. Antepartum Evaluations: Key Concepts and Protocol Specifications

2. Antepartum Schedule of Evaluations Modified in Protocol Version 2.0

3. After Entry, at which maternal antepartum visits are ALT and AST evaluated? • At every visit • Week 4 • Weeks 4, 12, 16, 20, & 24 • Weeks 4, 12, & 24

4. After Entry, at which maternal antepartum visits are creatinine and CrCl evaluated? • At every visit • Week 4 • Weeks 4, 12, 16, 20, & 24 • Weeks 4, 12, & 24

5. Maternal Cr and CrCl • Creatinine and CrCl evaluations are required at Antepartum Follow-Up Weeks 4, 12, and 24 • As soon as the creatinine results from these visits are obtained, the estimated CrCl rate should be: • Calculated using the Cockcroft-Gault formula • Graded for severity • Assessed for clinical significance concurrent with all other laboratory test results

6. After Entry, when is maternal hemoglobin evaluated? • At every visit • Week 4 • Weeks 4, 12, & 24 • Other (specify)

7. After Entry, when is plasma stored for mothers? • Antepartum Week 8 • Antepartum Weeks 4, 8, 12, & 24 • All antepartum follow-up visits • Other (specify)

8. After entry, when is plasma stored for mothers?

9. Where would you look in the protocol to find out what stored plasma will be used for?

10. Where would you look to find out how the blood volume specified for plasma storage should be processed? Laboratory Processing Chart

11. After Entry, maternal viral load testing is required at each antepartum follow-up visit. • True • False

12. Maternal Virologic Monitoring Results should be reviewed by study clinicians upon receipt and evaluated for the expected downward trend as mothers continue on ART.

13. Maternal Virologic Monitoring Footnote 5: It is generally not expected that mothers will meet criteria for confirmation of virologic failure during antepartum follow-up …

14. Why is it generally NOT expected that mothers will meet criteria for confirmation of virologic failure during antepartum follow-up?

15. The earliest a mother can enter the study is at 14 weeks gestation.

16. Maternal Virologic Monitoring It is generally not expected that mothers will meet the criteria for confirmation of virologic failure (≥200 copies/mL at or after at least 24 weeks on study) during antepartum follow-up; however, if these criteria are met prior to delivery, Confirmation of Virologic Failure Visit evaluations should be performed per protocol Section 6.7. Footnote 5

17. Additional Clinical Evaluations

18. Maternal Sleep and Anxiety • Possible side effects of efavirenz include: • Dizziness • Drowsiness • Trouble sleeping • Unusual dreams • Trouble concentrating • Severe depression • Other severe mental problems • Possible side effects of dolutegravir include: • Trouble sleeping • Tiredness • Headache • Severe depression

19. Maternal Sleep and Anxiety Assessments • Study will assess: • Sleep  Pittsburgh Sleep Quality Index • Anxiety  Generalized Anxiety Disorder 7-item (GAD-7) Scale • Depression  Edinburgh Postnatal Depression Scale Modified in Protocol Version 2.0 Study Entry, Antepartum Week 8, Postpartum Week 38 Postpartum Week 6 Postpartum Week 50

20. Maternal Sleep and Anxiety Assessments

21. What are your questions about VESTED Antepartum Follow-up?