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Bictegravir in the Elderly Living With HIV (BICEP)

NCT05064020 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 162

Last updated 2024-06-04

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • State University of New York at Buffalo

    lead OTHER

Principal Investigators

  • Qing Ma, PharmD, PhD · University at Buffalo

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05064020 on ClinicalTrials.gov