Table 2.
Sequence 2
| Protocol activity | Screening* | Rando** | Day 1 | Days 2–6 | Day 7 | Day 8 | Days 9–14 | Day 15 | Day 16 | Day 18 | Day 22 | Day 29 EOS |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Informed consent | X | |||||||||||
| Enrolment | X | |||||||||||
| Remdesivir | X | X | ||||||||||
| TDF/3TC | X | X | X | |||||||||
| Rich PK visit | X | X | ||||||||||
| Single PK sample | X | X | ||||||||||
| Washout period | ||||||||||||
| Clinical review | X | X | XT | XT | X | XT | X | |||||
| Vital signs | X | X | X | X | ||||||||
| HBV serology | X | |||||||||||
| HIV serology | X | |||||||||||
| Malaria RDT | X | |||||||||||
| Safety bloods | X | X | X | X | X | X | ||||||
| Urinalysis | X | X | ||||||||||
| Pregnancy test | X | X | X | |||||||||
| ECG | X | X | X | |||||||||
| Pharmacogenomic sample | X |
*14-day screening period, **At least 3 days prior to drug administration, XT telephone visit, RDT rapid diagnostic test, Rando randomization