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

  • STATUS
    Recruiting
  • End date
    Dec 13, 2022
  • participants needed
    50
  • sponsor
    Tulika Singh, MD
Updated on 13 December 2021

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.

Details
Condition HIV-1-infection
Treatment B/F/TAF
Clinical Study IdentifierNCT05147740
SponsorTulika Singh, MD
Last Modified on13 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Have been treated with B/F/TAF
Participants with CrCl <30 mL/min
Known or suspected severe hepatic impairment (Child-Pugh Class C)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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