The Efficacy, Safety, and Tolerability of Switching to a Bictegravir (BIC)/Emtricitabine(FTC)/Tenofovir Alafenamide (TAF) Regimen in Virally Suppressed Human Immunodeficiency Viruses (HIV)-Positive Patients Post-Renal Transplant
Overview
- Phase
- Phase 4
- Intervention
- BIC/F/TAF 50Mg-200Mg-25Mg Tablet
- Conditions
- HIV Infections
- Sponsor
- Weill Medical College of Cornell University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At least 18 years old on day of signing informed consent
- •Positive for human immunodeficiency virus (HIV)
- •Received a previous renal transplant
- •Must have controlled HIV infection for at least 3 months prior to enrollment
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
Arms & Interventions
Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF)
Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Intervention: BIC/F/TAF 50Mg-200Mg-25Mg Tablet
Outcomes
Primary Outcomes
Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml
Time Frame: 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)
Time Frame: 24 weeks, 48 weeks (End of study)
Renal Function as Measured by Creatinine
Time Frame: 24 weeks, 48 weeks (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
Time Frame: 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)
Time Frame: 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
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)
Secondary Outcomes
- 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))
- 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))
- 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))
- Number of Subjects With Rejection of the Kidney Transplant, Post Renal Transplant(up to 48 weeks (End of study))