Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV Infections, Renal Transplant Rejection

Intervention / Treatment
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* Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with plasma HIV-1 RNA <50 copies/ml | HIV viral loads will be obtained from lab reports | Week 48 | 
| Safety, as measured by number of participants with at least one adverse event | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Positive, Post Renal Transplant, Bictegravir/Emtricitabine/Tenofovir Alafenamide, Antiretroviral, Biktarvy