Phase 4 N=20 Treatment

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

HIV Infections · Renal Transplant Rejection

Bottom Line

View on ClinicalTrials.gov: NCT04530630 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Aug 2025

Primary outcome: Primary: Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml — 19 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: BIC/F/TAF 50Mg-200Mg-25Mg Tablet (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Weill Medical College of Cornell University
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml	19	—
PRIMARY Safety (Tolerability) as Measured by the Number of Subjects Who Had a Serious Adverse Event (SAE)	1	—
PRIMARY Intracellular TAF Levels as Measured by Dried Blood Spot	1.71; 1.18	—
PRIMARY Intracellular TAF Levels as Measured by Peripheral Blood Mononuclear Cells (PBMCs)	2.87; 2.76	—
PRIMARY Renal Function as Measured by Blood Urea Nitrogen (BUN)	25.21; 23.47	—
PRIMARY Renal Function as Measured by Creatinine	1.61; 1.57	—
PRIMARY Renal Function as Measured by Creatinine Clearance	58.10; 60.68	—
PRIMARY Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)	48.32; 49.21	—
PRIMARY Tacrolimus Levels	6.37; 7.97; 6.64	—
SECONDARY Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant	256.5263; 305.8333; 342.2105; 374.8947; 404.6667; 382.4211	—
SECONDARY Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant	22.6842; 25.667; 25.7368; 27.0526; 28.1111; 26.1579	—
SECONDARY Number of Subjects With Rejection of the Kidney Transplant, Post Renal Transplant	—	—
SECONDARY Participant Satisfaction With Reduced Pill Burden and Adverse Events (Tolerability) Measured by the Health-related Quality of Life Questionnaire	5.85; 5.89	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04530630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.