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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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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 : November 9, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Proportion of subjects with plasma HIV-1 RNA <50 copies/ml [ Time Frame: Week 48 ]
    HIV viral loads will be obtained from lab reports

  2. 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

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530630


Contacts
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Contact: Anna Gwak, BA 212-746-4089 ang4021@med.cornell.edu
Contact: Elizabeth L Salsgiver, MPH 212-746-4089 els7021@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Anna Gwak, BA    212-746-4089    ang4021@med.cornell.edu   
Contact: Elizabeth L Salsgiver, MPH    2127464089    els7021@med.cornell.edu   
Principal Investigator: Catherine B Small, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Gilead Sciences
Investigators
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Principal Investigator: Catherine B Small, MD Weill Medical College of Cornell University
Publications:
Eron JJ, Lelievre J-D, Kalayjian R, Slim J, et al. Safety and Efficacy of E/C/F/TAF in HIV-Infected Adults on Chronic Hemodialysis (Abstract, poster 732 presented at CROI 2018).

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04530630    
Other Study ID Numbers: 20-01021384
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Weill Medical College of Cornell University:
HIV Positive
Post Renal Transplant
Bictegravir/Emtricitabine/Tenofovir Alafenamide
Antiretroviral
Biktarvy
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents