Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant

February 7, 2024 updated by: Weill Medical College of Cornell University

The Efficacy, Safety, and Tolerability of Switching to a Bictegravir (BIC)/Emtricitabine(FTC)/Tenofovir Alafenamide (TAF) Regimen in Virally Suppressed HIV-Positive Patients Post-Renal Transplant

This is an open-label study, where participants will be switched from their current HIV medication to the study drug, Biktarvy. 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 Biktarvy. The investigator hypothesizes that Biktarvy 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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Biktarvy for treatment of HIV
  • Has allergies to any of the HIV medications in Biktarvy (bictegravir, emtricitabine, or tenofovir alafenamide)
  • Currently taking dofetilide or rifampin
  • Is pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biktarvy
Participants receive a Biktarvy tablet orally once daily with or without food.
Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet
A three-drug fixed dose combination tablet containing 50mg of bictegravir, 200mg of emtricitabine, and 25mg of tenofovir alafenamide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with plasma HIV-1 RNA <50 copies/ml
Time Frame: Week 48
HIV viral loads will be obtained from lab reports
Week 48
Safety, as measured by number of participants with at least one adverse event
Time Frame: Approximately 1 month after final study visit
Adverse events will only include those that are determined to be related to the study drug
Approximately 1 month after final study visit
Change in tolerated dose of Biktarvy in HIV positive post renal transplant participants as measured by HIV Treatment Satisfaction Questionnaire
Time Frame: Week 4, Week 12, Week 24, Week 36, Week 48, 3 Month Follow Up, 6 Month Follow Up
Tolerability will be measured by the health-related quality of life questionnaire to assess satisfaction with a one pill regimen. The health-related questionnaire ranges from 0 to 6 with higher scores indicating greater satisfaction.
Week 4, Week 12, Week 24, Week 36, Week 48, 3 Month Follow Up, 6 Month Follow Up
Change in interaction between plasma concentrations for Bictegravir/Emtricitabine/Tenofovir alafenamide, intracellular TAF levels, tacrolimus levels, and renal function
Time Frame: Day 1, Day 3, Day 5, Day 8, Day 11, Day 22, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48 (End of study), 3 Month Follow Up, 6 Month Follow Up
Relationships will be determined by linear regression analysis.
Day 1, Day 3, Day 5, Day 8, Day 11, Day 22, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48 (End of study), 3 Month Follow Up, 6 Month Follow Up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in CD4+ T lymphocyte cell count/percentages post renal transplant
Time Frame: Day 1, Week 4, Week 12, Week 24, Week 36, Week 48 (End of study), 3 Month Follow Up, 6 Month Follow Up
CD4 lymphocyte counts and percentages will be obtained from lab reports
Day 1, Week 4, Week 12, Week 24, Week 36, Week 48 (End of study), 3 Month Follow Up, 6 Month Follow Up
Correlation between rejection rates of the kidney transplant post renal and Tacrolimus levels
Time Frame: Approximately 3 months after primary outcome completion
Data for kidney graft rejection rates will be extracted from biopsy confirmed rejections and observed along with levels of Tacrolimus obtained from blood samples.
Approximately 3 months after primary outcome completion
Change in participants satisfaction with reduced pill burden, as measured by the health-related quality of life questionnaire
Time Frame: Week 4, Week 12, Week 24, Week 36, Week 48 (End of study), 3 Month Follow Up, 6 Month Follow Up
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.
Week 4, Week 12, Week 24, Week 36, Week 48 (End of study), 3 Month Follow Up, 6 Month Follow Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Catherine B Small, MD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2020

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

August 24, 2020

First Submitted That Met QC Criteria

August 24, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-01021384

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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