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Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant

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ClinicalTrials.gov Identifier: NCT04530630
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : November 23, 2020
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE August 24, 2020
First Posted Date  ICMJE August 28, 2020
Last Update Posted Date November 23, 2020
Actual Study Start Date  ICMJE November 9, 2020
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
  • Proportion of subjects with plasma HIV-1 RNA <50 copies/ml [ Time Frame: Week 48 ]
    HIV viral loads will be obtained from lab reports
  • 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
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Renal Transplant Rejection
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Biktarvy
Participants receive a Biktarvy tablet orally once daily with or without food.
Intervention: Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 24, 2020)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anna Gwak, BA 212-746-4089 ang4021@med.cornell.edu
Contact: Elizabeth L Salsgiver, MPH 212-746-4089 els7021@med.cornell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04530630
Other Study ID Numbers  ICMJE 20-01021384
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Gilead Sciences
Investigators  ICMJE
Principal Investigator: Catherine B Small, MD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP