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
|Condition or disease||Intervention/treatment|
|HIV/AIDS||Drug: bictegravir/emtricitabine/tenofovir alafenamide|
|Study Type :||Observational|
|Estimated Enrollment :||360 participants|
|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|
- Drug: bictegravir/emtricitabine/tenofovir alafenamide
Treatment experienced patients with HIV infection that switched to a bictegravir/emtricitabine/tenofovir alafenamide-based ART regimen
- 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 . 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.
- 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.
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
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Jason J Schafer, PharmD, MPH||Thomas Jefferson University|