Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant

Phase 4

Completed

• Conditions: HIV Infections; Renal Transplant Rejection
• Interventions: Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet

• Registration Number: NCT04530630
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-28
• Study Start: 2020-11-09
• Primary Completion: 2024-08-28
• Study Completion: 2024-08-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biktarvy	BIKTARVY 50Mg-200Mg-25Mg Tablet	Participants receive a Biktarvy tablet orally once daily with or without food.

Primary Outcome Measures

Name	Time	Method
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.
Proportion of subjects with plasma HIV-1 RNA <50 copies/ml	Week 48	HIV viral loads will be obtained from lab reports

Secondary Outcome Measures

Name	Time	Method
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
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.
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.

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States