Atripla (ATP: FTC/TDF/EFV) was the first single pill treatment for HIV and was the most prescribed first-line treatment from approximately 2008 to 2013 for people infected with HIV. However, ATP has not been recommended as a "preferred" treatment for HIV since 2015, due to there now being single pill treatments that work better. There are a lot of people who are still taking ATP and it is working for them. However, it has the potential to cause serious side effects (chronic kidney disease and fractures and serious neurological effects). These side effects are caused by components in ATP (namely the TDF and EFV parts). Also, the efavirenz (EFV) component is not compatible for treatment of Hepatitis C (HCV) - which is often also seen in people who have HIV. For these reasons, there is a need to find a better alternative treatment for these people currently being treated with ATP.
B/F/TAF (bictegravir/FTC/TAF) is an investigational single pill drug treatment drug that contains neither TDF nor EFV. This study is looking at whether changing people to this new drug treatment will continue to suppress their HIV and have fewer side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
B/F/TAF (Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir Alafenamide 25mg) Tablet taken orally once daily
Atripla (Efavirenz 600mg/ emtricitabine 200 mg/ tenofovir disoproxil 245 mg) Tablet taken orally once daily
Tablet taken orally once daily
Tablet taken orally once daily
University of Alberta
Edmonton, Alberta, Canada
Urine Albumin/Creatinine Ratio (UACR)
change in urine albumin/creatinine ratio (UACR)
Time frame: Baseline and week 48
HIV-1 RNA
Number of participants with HIV-1 RNA \< 50 copies/mL
Time frame: Week 48
Efavirenz (EFV) Symptom Scores
change in EFV symptom scores from Pittsburgh Sleep Quality Questionnaire (PSQI) global score. PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The PSQI global score has a possible range of 0-21. Higher scores represent worse sleep quality.
Time frame: Baseline and week 4
Urine Protein/Creatinine Ratio (UPCR)
change in urine protein/creatinine ratio (UPCR)
Time frame: Baseline and week 48
Estimated Glomerular Filtration Rate (eGFR)
change in estimated glomerular filtration rate (eGFR)
Time frame: Baseline and week 48
Bone Mineral Density (BMD) at the Hip
change in bone mineral density (BMD) at the hip
Time frame: Baseline and week 48
Bone Mineral Density (BMD) at the Spine
change in bone mineral density (BMD) at the spine
Time frame: Baseline and week 48
CD4 Lymphocyte Counts
change in CD4 lymphocyte counts
Time frame: Baseline and week 48
Serum Lipids
change in serum lipids
Time frame: Baseline and week 48
Adverse Events
number of adverse events
Time frame: Baseline, week 4, week 12, week 24, week 36, and week 48
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