Table 6. Out-patient schedule of events.
Study visit | Week 4 | Week 8 | Week 12 | Week 18 | Week 24 | Sick Visit |
---|---|---|---|---|---|---|
Visit window (weeks) | ±1 | ±1 | ±1 | ±2 | ±2 | As needed |
Dispensing of study drug | X | standard fixed dose therapy til 12 months as
per local guidelines |
||||
Interim history | X | X | X | TELEPHONE CONSULTATION OR IN PERSON | X | X |
Adverse events assessment | X | X | X | X | X | |
Medication review | X | X | X | X | X | |
Examination | X | X | X | X | X | |
Modified Rankin score | X | X | ||||
Detailed neurocognitive follow-up | X | X | ||||
Center for Epidemiological Studies
of Depression Scale (CES-D) |
X | X | ||||
Sodium, potassium | X (if clinically
indicated) |
|||||
Creatinine | X (if clinically
indicated) |
|||||
Hepatic Panel a | X | X | X (if clinically
indicated) |
|||
FBC, differential b | X (if clinically
indicated) |
|||||
Storage bloods c | X | X (IRIS event
only) |
||||
CSF with storage | X (if clinically
indicated) |
|||||
ART counselling d | X | X | ||||
Commence/switch ART d | X | |||||
Total volume of blood (ml) | 20 | 20 |
aHepatic panel = ALT, ALP, bilirubin +/- INR
bFBC; full/complete blood count
cBlood will be collected and stored for research if storage consent has been received, refer to site SOP.
dHIV-infected patients not receiving effective ART, ART counselling to be performed by qualified counsellors as per standard clinic procedures. Physician discretion allowed for timing of ART initiation.