This is an open-label study, where participants will be switched from their current HIV medication to the study drug, BIC/F/TAF. Open-label means both the investigator and the participant will know what drug will be given. Participants will be followed for 48 weeks in order to monitor the efficacy, safety and tolerability of BIC/F/TAF. The investigator hypothesizes that BIC/F/TAF will be an important addition to the management of HIV-positive post renal transplant patients, especially since it is a one pill daily dosing regimen, thereby decreasing the pill burden in this population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A three-drug fixed dose combination tablet containing 50mg of bictegravir, 200mg of emtricitabine, and 25mg of tenofovir alafenamide.
Weill Cornell Medicine
New York, New York, United States
Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml
HIV viral loads will be obtained from lab reports.
Time frame: Up to week 48 (End of Study)
Safety (Tolerability) as Measured by the Number of Subjects Who Had a Serious Adverse Event (SAE)
Time frame: Up to week 48 (End of study)
Intracellular TAF Levels as Measured by Dried Blood Spot
Fmol/punch refers to the concentration of a substance, measured in femtomoles per a specific size of a dried blood spot (DBS) punch.
Time frame: 12 weeks
Intracellular TAF Levels as Measured by Peripheral Blood Mononuclear Cells (PBMCs)
pmol/10\^6 cells refers to the amount of a particular substance (in picomoles) per one million cells
Time frame: 12 weeks
Renal Function as Measured by Blood Urea Nitrogen (BUN)
Time frame: 24 weeks, 48 weeks (End of study)
Renal Function as Measured by Creatinine
Time frame: 24 weeks, 48 weeks (End of study)
Renal Function as Measured by Creatinine Clearance
Time frame: 24 weeks, 48 weeks (End of study)
Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)
Time frame: 24 weeks, 48 weeks (End of study)
Tacrolimus Levels
Time frame: 12 weeks, 24 weeks, 48 weeks (End of study)
Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant
Number of CD4+ T lymphocyte counts will be obtained from lab reports
Time frame: Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study)
Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant
CD4+ T lymphocyte percentages will be obtained from lab reports
Time frame: Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study)
Number of Subjects With Rejection of the Kidney Transplant, Post Renal Transplant
Data for kidney graft rejection will be extracted from biopsy confirmed rejections.
Time frame: up to 48 weeks (End of study)
Participant Satisfaction With Reduced Pill Burden and Adverse Events (Tolerability) Measured by the Health-related Quality of Life Questionnaire
Satisfaction will be measured by the self-reporting health-related quality of life questionnaire ranging from 0 to 6 with higher scores indicating greater satisfaction with Biktarvy.
Time frame: Week 24, Week 48 (End of study)
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