Bictegravir in the Elderly Living With HIV (BICEP)

Status unconfirmed

Conditions studied: HIV-1-infection

In brief

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.

Key facts

Study ID

NCT05064020

Run by

State University of New York at Buffalo

People needed

162

Starts

2020-08-01

Expected to finish

2024-12-31

Last updated by the study team

2024-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult individuals > 18 years of age.
• Able and willing to provide informed/signed consent.
• Presence of HIV-1 infection as documented by a licensed ELISA test kit and confirmed by Western blot or HIV RNA.
• Current antiretroviral therapy, Genvoya or Stribild for HIV-1 infection.
• At least 1 or more concurrent prescription medication.
• HIV VL < 50 for over 6 months, no current OI, no cancers

You may not qualify if…

• Use of drugs of abuse or alcohol which would interfere with adherence or completion of this study.
• Current antiretroviral therapy other than GenvoyaTM or StribildTM for HIV-1 infection.
• Pregnancy or breast-feeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to study entry and day of entry.
• Chronic, severe, or other medical conditions that, in the opinion of the investigator, would interfere with the subject's ability to participate in the protocol.
• Use of prohibited protocol-specified drugs, prescription or over-the-counter medication (see Section 6.4.2) within 14 days prior to study entry.
• Moderate or severe cognitive impairment by history that, in the opinion of the investigator, would interfere with the subject's ability to participate in the protocol
• Laboratory parameters documented within 21 days prior to study entry that would increase the risk for adverse events:
• Hemoglobin < 12.5 g/dL for men; < 11.5 g/dL for women;
• Platelet count < 100,000 platelets/mm 3;
• AST (SGOT) or ALT (SGPT) > 1.5 x the upper limit of normal (ULN);
• Estimated GFR < 30 ml/min

Where it is running

• Evergreen Health — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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