Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04530630

Collaborator

Gilead Sciences (Industry)

Enrollment

Location

Arm

39.7

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Renal Transplant Rejection	Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 9, 2020

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Feb 29, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Proportion of subjects with plasma HIV-1 RNA <50 copies/ml [Week 48]
HIV viral loads will be obtained from lab reports
Safety, as measured by number of participants with at least one adverse event [Approximately 1 month after final study visit]
Adverse events will only include those that are determined to be related to the study drug
Change in tolerated dose of Biktarvy in HIV positive post renal transplant participants as measured by HIV Treatment Satisfaction Questionnaire [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.
Change in interaction between plasma concentrations for Bictegravir/Emtricitabine/Tenofovir alafenamide, intracellular TAF levels, tacrolimus levels, and renal function [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.

Secondary Outcome Measures

Change from baseline in CD4+ T lymphocyte cell count/percentages post renal transplant [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
Correlation between rejection rates of the kidney transplant post renal and Tacrolimus levels [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.
Change in participants satisfaction with reduced pill burden, as measured by the health-related quality of life questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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