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editorial
. 2019 Jan 1;5(1):10–22. doi: 10.1016/S2055-6640(20)30273-9
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
  • HIV-1 DNA

  • TILDA

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