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

Sponsor
Tulika Singh, MD (Other)
Overall Status
Recruiting
CT.gov ID
NCT05147740
Collaborator
Gilead Sciences (Industry)
50
Enrollment
1
Location
1
Arm
17
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Switching to a Fixed Dose Combination of Biktarvy in Treatment Experienced People With HIV Who Are Currently Virologically Suppressed and at Least 65 Years of Age
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: B/F/TAF

B/F/TAF for 48 weeks

Drug: B/F/TAF
50/200/25 mg fixed-dose combination administered orally once daily without regard to food.
Other Names:
  • Biktarvy®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey. [48 weeks]

      Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey. The range of scores is between -33 and +33. The higher the score, the greater the improvement in satisfaction. Satisfaction may be positive or negative.

    2. Improvement in overall quality of life as characterized by a change in total satisfaction scale as measured by the HIVDQoL survey. [48 weeks]

      Improvement in overall quality of life as characterized by a change in total satisfaction scale as measured by the HIVDQoL survey. The range of scores is between -9 to +3. The higher the score the greater the impact. Impacts may be positive or negative.

    Secondary Outcome Measures

    1. Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at W24 [Week 24]

      Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at W24 using FDA snapshot analysis, which defined a participant's virologic response status using only the viral load at the predefined timepoint within a certain window of time, along with study drug discontinuation.

    2. Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at end of study [Week 48]

      Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at end of study (Week 48) using FDA snapshot analysis, which defined a participant's virologic response status using only the viral load at the predefined timepoint within a certain window of time, along with study drug discontinuation.

    3. Percentage of Participants experiencing Adverse Events (AEs) through End of Study (Week 48) [Week 48]

      An Adverse Event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related . An AE can be any unfavorable and unintended sign, symptom, or disease associated with the use of a study intervention.

    4. Percentage of patients who reduced their number of total medications from baseline. [Week 48]

      Percentage of patients who reduced their number of total medications from baseline. Polypharmacy is defined as 5 or more prescription medications and the Beers Criteria is utilized as a tool to evaluate potentially inappropriate prescriptions in this population.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key 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.

    Key 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 DAP Health Palm Springs California United States 92262

    Sponsors and Collaborators

    • Tulika Singh, MD
    • Gilead Sciences

    Investigators

    • Principal Investigator: Tulika Singh, MD, DAP Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tulika Singh, MD, Director of Research and Associate Chief Medical Officer, Desert AIDS Project
    ClinicalTrials.gov Identifier:
    NCT05147740
    Other Study ID Numbers:
    • CO-US-38-5713
    First Posted:
    Dec 7, 2021
    Last Update Posted:
    Dec 7, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Tulika Singh, MD, Director of Research and Associate Chief Medical Officer, Desert AIDS Project
    HIV
    QOL
    Elderly

    Study Results

    No Results Posted as of Dec 7, 2021