Cellular Pharmacology and Platelet Effects of Abacavir and Lamivudine Anabolites
NCT ID: NCT04301661
Last Updated: 2023-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
25 participants
OBSERVATIONAL
2020-03-06
2021-12-17
Brief Summary
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Participants remaining on ABC/3TC- or TAF/FTC-containing therapy will be on study for 4 weeks, and will have two visits: a screening visit and one short PK visit consisting of a single blood draw at week 4.
Participants switching from their ABC/3TC-containing therapy will be on study for 3 weeks, and will have nine visits: a screening visit and 8 short PK visits consisting of a single blood draw at Day 0, 1, 3, 7, 10, 14, 18, and 21.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ABC/3TC Cohort
Persons on abacavir/lamivudine-containing therapy as part of their standard HIV care will continue to take their prescribed HIV medications.
Participants will be on study for 4 weeks, and will participate in directly observed therapy for the 4 weeks leading up to a single blood draw.
Blood collection
Blood will be collected from participants at defined time points during the study to measure drug levels and assess platelet activity.
Abacavir/lamivudine
Participants who are already taking abacavir/lamivudine as part of standard HIV care will continue taking their therapy.
TAF/FTC Cohort
Persons on tenofovir alafenamide/emtricitabine-containing therapy as part of their standard HIV care will continue to take their prescribed HIV medications.
Participants will be on study for 4 weeks, and will participate in directly observed therapy for the 4 weeks leading up to a single blood draw.
Blood collection
Blood will be collected from participants at defined time points during the study to measure drug levels and assess platelet activity.
Tenofovir alafenamide/emtricitabine
Participants who are already taking tenofovir alafenamide/emtricitabine as part of standard HIV care will continue taking their therapy.
Switch Cohort
Persons switching from abacavir/lamivudine-containing therapy as part of their standard HIV care will change to their newly prescribed regimen.
Participants will be on study for 3 weeks, and will have blood drawn at Days 0, 1, 3, 7, 10, 14, 18, and 21 following their switch.
Blood collection
Blood will be collected from participants at defined time points during the study to measure drug levels and assess platelet activity.
Switch
Participants who are planning to switch from abacavir/lamivudine as part of standard HIV care will change therapy to per the discretion of their HIV provider.
Interventions
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Blood collection
Blood will be collected from participants at defined time points during the study to measure drug levels and assess platelet activity.
Abacavir/lamivudine
Participants who are already taking abacavir/lamivudine as part of standard HIV care will continue taking their therapy.
Tenofovir alafenamide/emtricitabine
Participants who are already taking tenofovir alafenamide/emtricitabine as part of standard HIV care will continue taking their therapy.
Switch
Participants who are planning to switch from abacavir/lamivudine as part of standard HIV care will change therapy to per the discretion of their HIV provider.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
18 Years
99 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Kristina M Brooks, PharmD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Hospital
Aurora, Colorado, United States
Countries
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Other Identifiers
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18-2749
Identifier Type: -
Identifier Source: org_study_id
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