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Antiretroviral Agent
tenofovir-alafenamide-emtricitabine for Osteoporosis (BEING Trial)
Phase 4
Waitlist Available
Led By sharon walmsley, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 48 weeks and 96 weeks
Awards & highlights
BEING Trial Summary
This trial is testing whether a switch from one combination antiretroviral therapy (cART) to another may improve bone mineral density in aging HIV infected women.
Eligible Conditions
- Osteoporosis
- HIV/AIDS
- Menopause
BEING Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 48 weeks and 96 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 48 weeks and 96 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Change in Bone Mineral Density From Baseline at the Lumbar Spine
Secondary outcome measures
% Change in Bone Mineral Density From Baseline at the Femoral Neck
Side effects data
From 2021 Phase 4 trial • 34 Patients • NCT028155665%
Myocardial Infarction
5%
HIV Encephalitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Immediate Switch
Delayed Switch
Delayed Switch
BEING Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate switchExperimental Treatment1 Intervention
Open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for 96 weeks
Group II: delayed switchActive Control1 Intervention
Open-label tenofovir (300mg)-emtricitabine (200mg) tablet once daily by mouth for 48 weeks followed by open label tenofovir-alafenamide (25/10mg)-emtricitabine (200mg) tablet once daily by mouth for an additional 48 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir alafenamide
FDA approved
Find a Location
Who is running the clinical trial?
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
843,445 Total Patients Enrolled
CIHR Canadian HIV Trials NetworkNETWORK
40 Previous Clinical Trials
6,405 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,473 Previous Clinical Trials
484,971 Total Patients Enrolled
10 Trials studying Osteoporosis
3,160 Patients Enrolled for Osteoporosis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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