Clinical Case Scenarios
IMPAACT 2010/VESTED
Study-Specific Training
May 2017
Protocol References
Section
Title
Section 7
Section 8
Appendix II
Safety Assessment, Monitoring, and Reporting
Participant Management
Maternal Toxicity Management Guidelines
2
Scenario 1
Consider a 20 year old pregnant woman
who tested HIV-positive when presenting
for antenatal care on 1 August 2017 and
was then referred for possible participation
in IMPAACT 2010.
3
At screening, on 3 August 2017, this woman reports a
history of asthma since childhood. She does not routinely
take medication for this condition, but she has an inhaler
that she uses when needed.
She has had some nausea during the current pregnancy.
This has been occurring less often recently, but still occurs
from time to time. The nausea has not been accompanied
by vomiting.
Her screening laboratory results identify a grade 1
hemoglobin level; all other test results are normal.
(1) Based on the brief description provided here, what
additional information will the study clinician need
to probe for to adequately source document this
participant’s pre-existing medical conditions?
4
At screening, on 3 August 2017, this woman reports a
history of asthma since childhood. She does not routinely
take medication for this condition, but she has an inhaler
that she uses when needed.
She has had some nausea during the current pregnancy.
This has been occurring less often recently, but still occurs
from time to time. The nausea has not been accompanied
by vomiting.
Her screening laboratory results identify a grade 1
hemoglobin level; all other test results are normal.
(2) Assuming this woman is enrolled in the study,
what conditions would need to be entered into
the Medical History eCRF (if any)?
5
At screening, on 3 August 2017, this woman reports a
history of asthma since childhood. She does not routinely
take medication for this condition, but she has an inhaler
that she uses when needed.
She has had some nausea during the current pregnancy.
This has been occurring less often recently, but still occurs
from time to time. The nausea has not been accompanied
by vomiting.
Her screening laboratory results identify a grade 1
hemoglobin level; all other test results are normal.
(3) What updates of this participant’s baseline history
would need to be source documented? What new data
would need to be entered into eCRFs (if any)?
6
At antepartum Week 12, this participant reports a history
of nausea, vomiting, and diarrhea which started two days
ago. She has not taken her temperature but reports
periods of feeling hot and having intermittent chills. Her
husband has had similar symptoms for the past three days.
She has not been able to perform her usual household
tasks or eat solid food, but has been able to tolerate small
amounts of tea. The study clinician notes that the
participant appears unwell and has an axillary measured
fever of 39.2 C. Her blood pressure is 130/92.
(4) Based on the brief description provided here,
what would your differential diagnosis include for this
participant’s reported symptoms?
7
At antepartum Week 12, this participant reports a history
of nausea, vomiting, and diarrhea which started two days
ago. She has not taken her temperature but reports
periods of feeling hot and having intermittent chills. Her
husband has had similar symptoms for the past three days.
She has not been able to perform her usual household
tasks or eat solid food, but has been able to tolerate small
amounts of tea. The study clinician notes that the
participant appears unwell and has an axillary measured
fever of 39.2 C. Her blood pressure is 130/92.
(5) How would you manage this participant clinically?
What additional evaluations would you perform at the
Week 12 visit (if any)? Would your management involve
any changes of ARVs? What would your follow-up plan be?
8
At antepartum Week 12, this participant reports a history
of nausea, vomiting, and diarrhea which started two days
ago. She has not taken her temperature but reports
periods of feeling hot and having intermittent chills. Her
husband has had similar symptoms for the past three days.
She has not been able to perform her usual household
tasks or eat solid food, but has been able to tolerate small
amounts of tea. The study clinician notes that the
participant appears unwell and has an axillary measured
fever of 39.2 C. Her blood pressure is 130/92.
(6) What conditions would need to be entered into
Adverse Event eCRFs (if any)?
9
Scenario 2
• Consider a woman who enters IMPAACT
2010 at 27 weeks gestation and delivers
12 weeks later.
• The mother was randomized to Arm 3,
EFV/3TC/TDF, which she began at Entry.
• At Week 14 postpartum, she was clinically
well. However, her ALT result returned at
4.5 x ULN.
10
Consider a woman who enters IMPAACT 2010 at 27 weeks gestation
and delivers 12 weeks later. The mother was randomized to Arm 3,
EFV/3TC/TDF, which she began at Entry. At Week 14 postpartum, she
was clinically well. However, her ALT result
returned at 4.5 x ULN.
What grade is this laboratory value?
A.
B.
C.
D.
Grade 1
Grade 2
Grade 3
Grade 4
11
Consider a woman who enters IMPAACT 2010 at 27 weeks gestation
and delivers 12 weeks later. The mother was randomized to Arm 3,
EFV/3TC/TDF, which she began at Entry. At Week 14 postpartum, she
was clinically well. However, her ALT result returned at 4.5 x ULN.
What grade is this laboratory value?
12
Consider a woman who enters IMPAACT 2010 at 27 weeks gestation
and delivers 12 weeks later. The mother was randomized to Arm 3,
EFV/3TC/TDF, which she began at Entry. At Week 14 postpartum, she
was clinically well. However, her ALT result returned at 4.5 x ULN.
What management action would you take based on this result?
A.
Repeat ALT/AST within 3-4
business days
B. Check for signs of clinical
hepatitis
C. Check total and direct
bilirubin
D. All of the above
13
Consider a woman who enters IMPAACT 2010 at 27 weeks gestation
and delivers 12 weeks later. The mother was randomized to Arm 3,
EFV/3TC/TDF, which she began at Entry. At Week 14 postpartum, she
was clinically well. However, her ALT result returned at 4.5 x ULN.
At the follow-up visit, she confirms she had no symptoms and her
repeat labs confirm the initial Grade 2 ALT result. Should you inform
the CMC?
A. Yes
B. No
14
Consider a woman who enters IMPAACT 2010 at 27 weeks gestation
and delivers 12 weeks later. The mother was randomized to Arm 3,
EFV/3TC/TDF, which she began at Entry. At Week 14 postpartum, she
was clinically well. However, her ALT result returned at 4.5 x ULN.
At the follow-up visit, she confirms she had no
symptoms and her repeat labs confirm the
initial Grade 2 ALT result. What management
action would you take based on this result?
15
Consider a woman who enters IMPAACT 2010 at 27 weeks gestation
and delivers 12 weeks later. The mother was randomized to Arm 3,
EFV/3TC/TDF, which she began at Entry. At Week 14 postpartum, she
was clinically well. However, her ALT result returned at 4.5 x ULN.
How would your management change if the
woman reported vomiting and malaise at
her Week 14 postpartum visit?
16
Consider a woman who enters IMPAACT 2010 at 27 weeks gestation
and delivers 12 weeks later. The mother was randomized to Arm 3,
EFV/3TC/TDF, which she began at Entry. At Week 14 postpartum, she
was clinically well. However, her ALT result returned at 4.5 x ULN.
How would your management change if the
woman reported vomiting and malaise at
her Week 14 postpartum visit?
17
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