Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) After Renal Transplant

Phase 4

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Received a kidney from a donor who was HIV positive (unless a false positive)
Currently taking BIC/F/TAF for treatment of HIV
Has allergies to any of the HIV medications in BIC/F/TAF (bictegravir, emtricitabine, or tenofovir alafenamide)
Currently taking dofetilide or rifampin
Is pregnant or breastfeeding

Arm && Interventions

Group	Intervention	Description
Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF)	BIC/F/TAF 50Mg-200Mg-25Mg Tablet	Participants receive a BIC/F/TAF tablet orally once daily with or without food.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml	Up to week 48 (End of Study)	HIV viral loads will be obtained from lab reports.
Renal Function as Measured by Blood Urea Nitrogen (BUN)	24 weeks, 48 weeks (End of study)
Renal Function as Measured by Creatinine	24 weeks, 48 weeks (End of study)
Safety (Tolerability) as Measured by the Number of Subjects Who Had a Serious Adverse Event (SAE)	Up to week 48 (End of study)
Intracellular TAF Levels as Measured by Dried Blood Spot	12 weeks	Fmol/punch refers to the concentration of a substance, measured in femtomoles per a specific size of a dried blood spot (DBS) punch.
Intracellular TAF Levels as Measured by Peripheral Blood Mononuclear Cells (PBMCs)	12 weeks	pmol/10\^6 cells refers to the amount of a particular substance (in picomoles) per one million cells
Renal Function as Measured by Creatinine Clearance	24 weeks, 48 weeks (End of study)
Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)	24 weeks, 48 weeks (End of study)
Tacrolimus Levels	12 weeks, 24 weeks, 48 weeks (End of study)

Secondary Outcome Measures

Name	Time	Method
Participant Satisfaction With Reduced Pill Burden and Adverse Events (Tolerability) Measured by the Health-related Quality of Life Questionnaire	Week 24, Week 48 (End of study)	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.
Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant	Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study)	Number of CD4+ T lymphocyte counts will be obtained from lab reports
Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant	Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study)	CD4+ T lymphocyte percentages will be obtained from lab reports
Number of Subjects With Rejection of the Kidney Transplant, Post Renal Transplant	up to 48 weeks (End of study)	Data for kidney graft rejection will be extracted from biopsy confirmed rejections.