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The Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment Experienced Patients

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ClinicalTrials.gov Identifier: NCT03789968
Recruitment Status : Enrolling by invitation
First Posted : December 31, 2018
Last Update Posted : September 11, 2019
Sponsor:
Collaborators:
University of Maryland, College Park
Indiana University Health
The Brooklyn Hospital Center
University of Illinois at Chicago
Nova Southeastern University
University of California, San Francisco
Information provided by (Responsible Party):
Jason Schafer, Thomas Jefferson University

Brief Summary:
This study will assess changes in the incidence and severity of drug interactions before and after switching antiretroviral therapy to bictegravir/emtricitabine/tenofovir alafenamide-based regimens in treatment experienced patients living with HIV infection.

Condition or disease Intervention/treatment
HIV/AIDS Drug: bictegravir/emtricitabine/tenofovir alafenamide

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment Experienced Patients
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020



Intervention Details:
  • Drug: bictegravir/emtricitabine/tenofovir alafenamide
    Treatment experienced patients with HIV infection that switched to a bictegravir/emtricitabine/tenofovir alafenamide-based ART regimen


Primary Outcome Measures :
  1. Changes in drug interactions after switching to bictegravir/emtricitabine/tenofovir alafenamide [ Time Frame: 1 year ]
    The primary endpoint is to measure the change in mean total drug interaction scores pre and post ART switch to a bictegravir/emtricitabine/tenofovir alafenamide-based regimen. The total drug interaction scores for each patient pre- and post-switch will be calculated using a drug interaction score developed for this study. The score is obtained when entering a patient's ART and concomitant medications (CM) into the University of Liverpool's HIV Drug Interaction Checker database [21]. Each ART-CM pair is given one of the following scores: "do not co-administer" is a score of 2, "potential interaction" a score of 1, and "potential weak interaction" or "no interaction" a score of 0. When no interactions are observed between a patient's ART and CMs, the total score will be 0. Higher scores occur when interactions are present. A decrease in score indicates that switching to bictegravir/emtricitabine/tenofovir alafenamide decreased the number and severity of interactions present.


Secondary Outcome Measures :
  1. Predictors of achieving drug interaction score reductions after switching to bictegravir/emtricitabine/tenofovir alafenamide [ Time Frame: 1 year ]
    The secondary endpoint of the study is to identify predictors of drug interaction score reductions after switching to a bictegravir/emtricitabine/tenofovir alafenamide. Predictors will be examined using multivariable linear regression. Initial models will include all a priori variables which will be examined for multi-collinearity. Models will be fit using a backwards selection procedure. Candidate predictors will be eliminated individually by comparing the log likelihood ratio test for each model step and using the 5% significance level.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults living with HIV infection and receiving antiretroviral therapy who have changed treatments to bictegravir/emtricitabine/tenofovir alafenamide
Criteria

Inclusion Criteria:

  1. HIV diagnosis
  2. 18 years of age or older
  3. Receiving ART for at least 3 months
  4. ART is switched to bictegravir/emtricitabine/tenofovir alafenamide between 2/7/2018 and 3/30/2019
  5. Patient is receiving at least one chronic or as needed non-ART medication at the time of the switch

Exclusion Criteria:

-


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): NCT03789968


Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
University of Maryland, College Park
Indiana University Health
The Brooklyn Hospital Center
University of Illinois at Chicago
Nova Southeastern University
University of California, San Francisco
Investigators
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Principal Investigator: Jason J Schafer, PharmD, MPH Thomas Jefferson University

Additional Information:
Publications:

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Responsible Party: Jason Schafer, Associate Professor, Department of Pharmacy, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03789968     History of Changes
Other Study ID Numbers: 18G.786
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
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.: Yes
Additional relevant MeSH terms:
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Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
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