NCT04530630CompletedPhase 4
Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) After Renal Transplant
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
Source: ClinicalTrials.gov · Last updated 12 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 24 Aug 2020
- Start date
- 9 Nov 2020
- Primary completion date
- 28 Aug 2024
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- HIV
- NCT number
- NCT04530630
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 20
- From 9 Nov 2020 to the primary completion date, 28 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received a kidney from a donor who was HIV positive (unless a false positive)
- Currently taking BIC/F/TAF for treatment of HIV
- Currently taking dofetilide or rifampin
Other illness
- Has allergies to any of the HIV medications in BIC/F/TAF (bictegravir, emtricitabine, or tenofovir alafenamide)
Other
- Is pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.