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ACTIVE NOT RECRUITING
NCT05064020

Bictegravir in the Elderly Living With HIV (BICEP)

Sponsor: State University of New York at Buffalo

View on ClinicalTrials.gov

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

DRUG

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