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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03656783
The ClinicalTrials.gov registry entry for NCT03656783 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (94% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.