Study to Assess Switching to B/F/TAF in Treatment Experienced People With HIV Who Are at Least 65 Years of Age

NCT ID: NCT05147740

Last Updated: 2021-12-07

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-12-31

Brief Summary

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To assess patient reported treatment satisfaction and medication tolerability in virologically suppressed HIV-1 infected adults who are at least 65 years of age who switch to a bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination regimen.

Detailed Description

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Conditions

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HIV-1-infection

Keywords

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HIV QOL Elderly

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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B/F/TAF

B/F/TAF for 48 weeks

Group Type EXPERIMENTAL

B/F/TAF

Intervention Type DRUG

50/200/25 mg fixed-dose combination administered orally once daily without regard to food.

Interventions

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B/F/TAF

50/200/25 mg fixed-dose combination administered orally once daily without regard to food.

Intervention Type DRUG

Other Intervention Names

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Biktarvy®

Eligibility Criteria

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Inclusion Criteria

1. Be at least 65 years of age at the time of signing the informed consent form.
2. Be currently receiving an antiretroviral regimen for ≥ 3 months prior to the screening visit.
3. Have documented plasma HIV-1 RNA \< 50 copies/mL for a minimum of 3 months on current ART regimen.
4. Have a plasma HIV-1 RNA \< 50 copies/mL at screening visit.

Exclusion Criteria

1. Have resistance to tenofovir (K65R/E/N, ≥3 thymidine analogue mutations or T69-insertions), primary INSTI-resistance, or a history of failure on an INSTI-based regimen.
2. Have been treated with B/F/TAF
3. Participants with CrCl \<30 mL/min
4. Known or suspected severe hepatic impairment (Child-Pugh Class C)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Tulika Singh, MD

OTHER

Sponsor Role lead

Responsible Party

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Tulika Singh, MD

Director of Research and Associate Chief Medical Officer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tulika Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Dap Health

Locations

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DAP Health

Palm Springs, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Greg Jackson, BS, MBA

Role: CONTACT

Phone: 760-992-0445

Email: [email protected]

Facility Contacts

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Greg Jackson, BS, MBA

Role: primary

Karina Ramirez

Role: backup

Other Identifiers

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CO-US-38-5713

Identifier Type: -

Identifier Source: org_study_id