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NCT03656783 · ClinicalTrials.gov registry record · Phase 3
Effects of Biktarvy on CFR in Stable HIV Patients
A Phase 3 study of HIV, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 25
- Enrollment target
- 3
- Study locations
NCT03656783: Completed Phase 3 study of HIV, sponsored by Brigham and Women's Hospital.
NCT03656783 is a Phase 3 study of HIV that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 25 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03656783, a Phase 3 study of HIV, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 25 participants
- Enrollment target
- 3
- Study locations
Study Summary
Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single pill regimen that was approved by the FDA in February 2018 for treatment of HIV. The marketed name of the drug is Biktarvy. In two phase 3 comparative clinical trials, including one with ABC/3TC/DTG, it was found to be non-inferior to dolutegravir-containing regimens in terms of virologic outcomes. B/F/TAF was also well tolerated, with few discontinuations for adverse events. As a result, B/F/TAF is an ideal non-abacavir containing regimen to assess the effect of removing ABC on coronary flow reserve.
Primary Outcome
Change in global coronary flow reserve, as measured by PET imaging at baseline and 24 weeks after initiation of B/F/TAF therapy. Coronary flow reserve (CFR), the ratio of peak vasodilator stress to rest myocardial blood flow (MBF), represents the maximal ability to augment coronary flow and myocardial perfusion. Absolute MBF was computed from the rest and stress myocardial perfusion PET images using commercially available software (Corridor4DM; Ann Arbor, Michigan) and a two-compartment tracer
Conditions Studied
Interventions
- DRUG Biktarvy
Study Locations (3)
Massachusetts
- Tufts Medical Center - Boston
- Brigham and Women's Hospital - Boston
- Boston Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-09-14 |
| Est. Completion | 2021-09-15 |
| Phase | Phase 3 |
What the finished NCT03656783 record still lists
NCT03656783 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (94% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 1 intervention - of which Biktarvy is the first listed.
NCT03656783 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03656783 about?
NCT03656783 is a clinical study titled "Effects of Biktarvy on CFR in Stable HIV Patients". Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a single pill regimen that was approved by the FDA in February 2018 for treatment of HIV. The marketed name of the drug is Biktarvy. In two phase 3 comparative clinical trials, including one with ABC/3TC/DTG, it was found to be non-inferio...
What is the current status of trial NCT03656783?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2018-09-14. Estimated completion is 2021-09-15.
What conditions does trial NCT03656783 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT03656783?
The interventions under investigation include: Biktarvy (DRUG).
Who is sponsoring clinical trial NCT03656783?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03656783 being conducted?
This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03656783's enrollment target sits among peer trials
25 278th of 303 higher than 26 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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