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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights
Study Summary
This trial assesses patient satisfaction and medication tolerability in HIV-1 infected adults over 65 who switch to a fixed-dose combination regimen of bictegravir/emtricitabine/tenofovir alafenamide.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement in overall quality of life as characterized by a change in total satisfaction scale as measured by the HIVDQoL survey.
Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey.
Secondary outcome measures
Percentage of Participants experiencing Adverse Events (AEs) through End of Study (Week 48)
Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at W24
Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at end of study
+1 moreSide effects data
From 2023 Phase 4 trial • 28 Patients • NCT0379701418%
Upper respiratory tract infection
7%
Abdominal pain
7%
Abscess, extremity
7%
Back pain
7%
Headache
7%
Hypertension
7%
Nausea
7%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
B/F/TAF
Trial Design
1Treatment groups
Experimental Treatment
Group I: B/F/TAFExperimental Treatment1 Intervention
B/F/TAF for 48 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
B/F/TAF
2016
Completed Phase 4
~4900
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Who is running the clinical trial?
Tulika Singh, MDLead Sponsor
Gilead SciencesIndustry Sponsor
1,082 Previous Clinical Trials
842,791 Total Patients Enrolled
Frequently Asked Questions
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