Status:
COMPLETED
Cellular Pharmacology and Platelet Effects of Abacavir and Lamivudine Anabolites
Lead Sponsor:
University of Colorado, Denver
Conditions:
HIV-1-infection
Eligibility:
All Genders
18-99 years
Brief Summary
This study will evaluate the intracellular pharmacokinetics and platelet effects of abacavir (ABC), lamivudine (3TC), tenofovir alafenamide (TAF), and emtricitabine (FTC) in persons living with HIV th...
Detailed Description
Abacavir and lamivudine are recommended antiretroviral medications used in the treatment of human immunodeficiency virus (HIV) infection in the United States and globally. Both agents are nucleos(t)id...
Eligibility Criteria
Inclusion
- ABC/3TC Cohort:
- On abacavir 600 mg/lamivudine 300 mg-containing regimen as part of their ART for at least 6 months prior to entry
- HIV-1 RNA \<200 copies/mL at screening and within the previous 6 months
- TAF/FTC Cohort:
- On tenofovir alafenamide 25 mg/emtricitabine 200 mg-containing regimen as part of standard care for at least 6 months prior to entry
- HIV-1 RNA \<200 copies/mL at screening and within the previous 6 months
- Switch Cohort:
- \- Switching from an abacavir/lamivudine-containing regimen (to any other ART regimen not containing ABC/3TC) as part of standard care as recommended by their HIV provider
Exclusion
- eGFR \<50 mL/min/1.73 m2
- Platelet count \<100,000 cells/mm3
- Current or previous use (within 30 days) of anticoagulant or antiplatelet medications (e.g., aspirin, P2Y12 inhibitors, vitamin K antagonists, anti-Xa inhibitors, thrombin inhibitors, etc.)
- History of cardiovascular event(s) (e.g., myocardial infarction, cerebrovascular accident (stroke), peripheral arterial thrombosis, etc.), platelet or bleeding disorders
- Pregnant or planning pregnancy
- Any uncontrolled medical, social, or mental-health issue(s) that, in the opinion of the investigators, could interfere with study participation or the study outcomes
- Inability to comply with directly observed dosing (i.e., lack of availability or ability to use video streaming technology)
Key Trial Info
Start Date :
March 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 17 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04301661
Start Date
March 6 2020
End Date
December 17 2021
Last Update
January 9 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045