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Table 3 Trial procedures and Timelines

From: A phase IV randomised, open-label pilot study to evaluate switching from protease-inhibitor based regimen to Bictegravir/Emtricitabine/Tenofovir Alafenamide single tablet regimen in Integrase inhibitor-naïve, virologically suppressed HIV-1 infected adults harbouring drug resistance mutations (PIBIK study): study protocol for a randomised trial

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  
  1. FV Fasting visit, HIV-SI HIV symptom distress module, PSQI Pittsburgh Sleep Quality Index, BMI Body mass index, UPCR urine protein creatinine ratio, HBV Hepatitis B virus, HCV Hepatitis C virus, LDL Low density lipoprotein, HDL High density lipoprotein