Skip to main content
OpenTrials
Completed

NCT Number: NCT04530630

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Renal Transplant Rejection Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Weill Cornell Medicine

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Other names: Biktarvy

Primary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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

  5. Renal Function as Measured by Blood Urea Nitrogen (BUN)

    Time frame: 24 weeks, 48 weeks (End of study)

  6. Renal Function as Measured by Creatinine

    Time frame: 24 weeks, 48 weeks (End of study)

  7. Renal Function as Measured by Creatinine Clearance

    Time frame: 24 weeks, 48 weeks (End of study)

  8. Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)

    Time frame: 24 weeks, 48 weeks (End of study)

  9. Tacrolimus Levels

    Time frame: 12 weeks, 24 weeks, 48 weeks (End of study)

Secondary outcomes

  1. Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant

    Time frame: 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

  2. Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant

    Time frame: 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

  3. Number of Subjects With Rejection of the Kidney Transplant, Post Renal Transplant

    Time frame: up to 48 weeks (End of study)

    Data for kidney graft rejection will be extracted from biopsy confirmed rejections.

  4. Participant Satisfaction With Reduced Pill Burden and Adverse Events (Tolerability) Measured by the Health-related Quality of Life Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2020
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.