Timepoint | Study period | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pre-incl T−1 | Incl T0 | D1 | D3 | D7 | W2 | W3 | W4 | W5 | W6 | W7 | W8 | W12 | W28 | Close-out W40 | |
Enrolment | |||||||||||||||
Eligibility Criteria | x | ||||||||||||||
Informed Consent | x1 | x2 | |||||||||||||
Randomization | x | ||||||||||||||
Intervention | |||||||||||||||
Study medication | x | x | x | x | x | x | x | x | x | x | x | ||||
Other treatments | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x |
Antiviral treatment *** | (x) | (x) | (x) | (x) | (x) | (x) | (x) | x | x | x | x | x | x | x | x |
Assessment | |||||||||||||||
Clinical assessment | |||||||||||||||
Physical. examination* | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x |
Visual tests ** | x | x | x | x | x | x | x | x | x | x | x | x | x | x | |
Neuropathy tests ** | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x |
Functional tests ** | x | x | x | x | x | x | x | x | x | x | x | x | x | x | |
Cognitive tests ** | x | ||||||||||||||
Depression tests ** | x | ||||||||||||||
Imaging | |||||||||||||||
Brain imaging | (x3) | ||||||||||||||
Chest X-ray | x | ||||||||||||||
Blood test | |||||||||||||||
HIV serology | x | ||||||||||||||
Full blood count † | x | x | x | x | x | x | x | x | x | x | x | x* | x* | ||
Plasma electrolytes †† | x | x | x | x | x | x | x | x | x | x | x | x* | |||
Creatininemia | x | x | x | x | x | x | x | x | x | x | x | x* | |||
Glycemia | x | x | x | x | x | x | x | x | x | x | x | ||||
Albuminemia | x | x | x | ||||||||||||
ALT, Bilirubin (T/U) | x | x | x | x | x | x | x | x | x | x | x | x* | x* | ||
Cryptococcus Ag * | x* | ||||||||||||||
HIV-1 RNA Viral load * | x* | x* | x* | x* | x* | ||||||||||
CD4 cell count * | x* | x* | x* | x* | |||||||||||
PK rifampicin/linezolid | x | x | |||||||||||||
Urine tests | |||||||||||||||
Rapid Pregnancy test | x | ||||||||||||||
Urine LAM * | x* | ||||||||||||||
CSF | |||||||||||||||
TBM tests ‡ | x | (x1) | x | (x2) | |||||||||||
Bacterial tests ¥ | x | ||||||||||||||
Cryptococcus Ag * | x* | ||||||||||||||
PK rifampicin/linezolid | x | x | |||||||||||||
Sputum TB tests | x | (x3) |