Weeks | Screening (− 30 days) | Baseline (FV) | 4 | 12 | 24 (FV) | 28 | 36 | 48 (FV) | Early termination visit (FV) | 30 day post treatment follow up (telephone call or standard of care clinic visit) |
---|---|---|---|---|---|---|---|---|---|---|
Informed consent | X | |||||||||
Demographic data and medical history including full ART history | X | |||||||||
Eligibility criteria | X | X | ||||||||
Review of historical drug resistance tests | X | |||||||||
Adverse events | X | X | X | X | X | X | X | X | X | |
Concomitant medications | X | X | X | X | X | X | X | X | X | X |
HIV-SI | X | X | X | X | ||||||
PSQI | X | X | X | X | ||||||
HIV associated conditions | X | X | X | X | X | X | X | X | X | X |
Randomisation | X | |||||||||
e-Case Report Forms | X | X | X | X | X | X | X | X | X | X |
Vital signs (Blood Pressure, Pulse, temperature, weight) | X | X | X | X | X | X | X | |||
Complete/asymptom directed physical examination | X | Xa | Xa | Xa | Xa | Xa | Xa | Xa | Xa | |
Height | X | |||||||||
Weight, BMI & waist circumference | X | X | X | X | X | X | X | |||
12 Lead ECG | X | X | X | X | ||||||
Urinalysis | X | X | X | X | X | X | X | |||
Urine Pregnancy Test | X | X | X | X | X | X | X | |||
CD4/CD8 T cell count | X | X | X | X | ||||||
HIV-1 RNA viral load (& resistance testing if > 50 copies/mL) | X | X | X | X | X | X | X | X | X | |
Whole blood for Proviral DNA | X | |||||||||
Haematology | X | X | X | X | X | X | X | |||
Urea, electrolytes, creatinine, phosphate, glucose, calcium, amylase | X | X | X | X | X | X | X | |||
Estimated GFR | X | X | X | X | X | X | X | |||
UPCR | X | X | X | X | X | X | X | |||
HBV & HCV serology | X | |||||||||
Liver function tests | X | X | X | X | X | X | X | |||
Lipids (Fasting Cholesterol, LDL, HDL, Triglycerides) | X | X | X | X | ||||||
HbA1c | X | X | X | X | ||||||
Pill count adherence | X | X | X | X | X | X | X | X | ||
Self-reported adherence | X | X | X | X | X | X | X | X | ||
Study drug dispensation | X | X | X | X | X | X | ||||
Study drug accountability | X | X | X | X | X | X | X |