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

NCT03789968 | Completed FDA Drug

• 1 other identifier: 18G.786
• Study Type: observational
• Target: 411
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Changes in drug interactions after switching to bictegravir/emtricitabine/tenofovir alafenamide

  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.

  1 year

Secondary Outcomes (1)

• Predictors of achieving drug interaction score reductions after switching to bictegravir/emtricitabine/tenofovir alafenamide

  1 year

Interventions

bictegravir/emtricitabine/tenofovir alafenamide DRUG

Treatment experienced patients with HIV infection that switched to a bictegravir/emtricitabine/tenofovir alafenamide-based ART regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• University of Maryland, College Park: collaborator
• Indiana University Health: collaborator
• The Brooklyn Hospital Center: collaborator
• University of Illinois at Chicago: collaborator
• Nova Southeastern University: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (19)

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Related Links

• HIV Drug Interactions. University of Liverpool.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jason J Schafer, PharmD, MPH

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Pharmacy

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: December 31, 2018
• Study Start: September 1, 2019
• Primary Completion: September 5, 2020
• Study Completion: October 5, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)