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Bictegravir in the Elderly Living With HIV (BICEP)
Sponsor: State University of New York at Buffalo
Summary
This is a prospective, open-label, single center, post-approval and post-marketing study. Current national guideline recommends an integrase strand inhibitors (INSTI) in combination with two nucleoside reverse transcriptase inhibitors (NRTIs) as standard of therapy for HIV-1 infected patients. INSTI-based regimen may require a potent CYP3A inhibitor such as cobicistat to increase INSTI's plasma concentration and prolongs half-life. However, co-administration with a CYP3A inhibitor may increase the risk of drug-drug interactions. A novel INSTI, bictegravir, does not need a booster for pharmacokinetic enhancement. Hypothesis: switching HIV-1 infected patients from booster containing regimen to bictegravir based regimen would decrease the risk of drug-drug interactions caused by a booster and improve quality of life and adherence.
Official title: Bictegravir in the Elderly Living With HIV: Impact of Polypharmacy and Multimorbidity (BICEP)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
162
Start Date
2020-08-01
Completion Date
2024-12-31
Last Updated
2024-06-04
Healthy Volunteers
No
Conditions
Interventions
Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]
Administer BIC/FTC/TAF 50/200/25 mg tablet by mouth once a day from day 1 to168.
Locations (1)
Evergreen Health
Buffalo, New York, United States