CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
BIC/F/TAF 50Mg-200Mg-25Mg Tabletdrug
Likely dose
BIC/F/TAF 50Mg-200Mg-25Mg Tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04530630
NCT04530630Phase 4Completed

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

Weill Medical College of Cornell University·interventional·Posted Aug 28, 2020·Updated Aug 12, 2025

In Brief

A Phase 4 clinical trial evaluating BIC/F/TAF 50Mg-200Mg-25Mg Tablet for HIV Infections and Renal Transplant Rejection. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGilead Sciences

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedAug 28, 2020
Enrollment StartNov 9, 2020
Primary CompletionAug 28, 2024
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 5.8 years ago

Interventions

BIC/F/TAF 50Mg-200Mg-25Mg Tabletdrug

A three-drug fixed dose combination tablet containing 50mg of bictegravir, 200mg of emtricitabine, and 25mg of tenofovir alafenamide.