Screening | Days | Treatment interruption – follow-up | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Time Window | ± 7 days | ± 2 days (except D25 ± 4) | ± 2 days | ||||||||
Days (D) | D-21 | D0 | D7 | D14 | D21 | D25 | D28 | Twice weekly for 3 weeks | Every week till VR | ART reintroduction visit | FU visit(s)*** |
Informed consent | X | ||||||||||
Check of IN/EX criteria | X | X | |||||||||
Physical examination | X | X | X | X | X | X | X | X | X | X | X |
Body weight (kg) | X | X | X | X | X | X | X | X | X | X | X |
Height measurement (cm) | X | ||||||||||
Medical history | X | ||||||||||
Telephone calls to participants | Day 3 and 5 | ||||||||||
Serology for HBV, HCV, HIV | X | ||||||||||
Haematology and biochemistry | X | X | X | X | X | X | X | X | X | X***** | |
CD4 and CD8 count | X | X | X | X | X | X | X | X | X | X | X |
Urinalysis | X | X | X | X | X | X | X | X**** | X | X | |
Blood pregnancy test | X | ||||||||||
Urine pregnancy test | X | X | X | X | X | X | X | X | X | ||
Vital signs | X | X | X | X | X | X | X | X | X | ||
ECG (12 lead) | X | X | X | X | X | ||||||
DRV/RTV or COBI prescription | X | X | X | X | X | X | X | X | X | ||
ABX464/placebo treatment dispensation and patient diary review | X | X | X | X | X | X | |||||
Blood samples–drug PK | X* | X* | X* | X* | X** | ||||||
Blood samples for viral load and miRNA | X | X | X | X | X | X | X | X | X | X | X |
HIV-1 genotyping | X | ||||||||||
Leukapheresis (optional) | X | X | |||||||||
Blood samples for reservoir assessment
|
X | X | X | X
X |
|||||||
Adverse events recording | X | X | X | X | X | X | X | X | X |
DRV: darunavir; RTV: ritonavir; COBI: cobiscistat; FU: follow-up; VR: viral rebound.
*: pre DRV/RTV or DRV/COBI morning dose
**: pre DRV/RTV or DRV/COBI morning dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 h post-dose (hospitalisation was not required)
***: every 14 days till undetectable viral load
****: urinalysis performed once a week
*****: only biochemistry required and for at least 28 days after treatment interruption