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NCT04001803 · ClinicalTrials.gov registry record · Phase 3
Study to Identify and Determine Best Implementation Practices for Injectable Cabotegravir+Rilpivirine in the United States (US)
A Phase 3 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 115
- Enrollment target
NCT04001803 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 115 participants.
The verdict
NCT04001803, a Phase 3 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 115 participants
- Enrollment target
Study Summary
Chronic human immunodeficiency virus (HIV) infection in adults continues to be characterized by increased development of resistant virus, increased transmission of resistant virus and issues associated with the long-term toxicity of anti-retroviral therapy (ART), despite advances in development of new ART, which provides extensive insight in management of HIV-infected individuals. Cabotegravir (CAB) is a potent integrase inhibitor (INI) and rilpivirine (RPV) is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI). A two-drug regimen (DR)with CAB plus RPV long acting (LA) product offers many potential advantages over daily oral regimens including better tolerability, improved compliance, adherence, less likely to develop resistance, and overall treatment satisfaction in virologically suppressed subjects. This is a single-arm, open-label, multicenter, short term facilitation study to evaluate the effect of an implementation strategy on the degree of acceptability, appropriateness, feasibility, fidelity and sustainability of clinical practices to deliver the CAB+RPV LA regimen to HIV infected subjects and to also measure subject satisfaction by recording timeliness of visits, length of visit and their education. Approximately 135 subjects will be enrolled in the study and the total duration of the study will be approximately 52-weeks.
Interventions
- DRUG CAB LA+RPV LA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2019-07-08 |
| Est. Completion | 2022-03-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04001803
The ClinicalTrials.gov registry entry for NCT04001803 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CAB LA+RPV LA is the first listed.
NCT04001803 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04001803 about?
NCT04001803 is a clinical study titled "Study to Identify and Determine Best Implementation Practices for Injectable Cabotegravir+Rilpivirine in the United States (US)". Chronic human immunodeficiency virus (HIV) infection in adults continues to be characterized by increased development of resistant virus, increased transmission of resistant virus and issues associated with the long-term toxicity of anti-retroviral therapy (ART), despite advances in development of n...
What is the current status of trial NCT04001803?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 115 participants. The study started on 2019-07-08. Estimated completion is 2022-03-18.
What interventions are being tested in trial NCT04001803?
The interventions under investigation include: CAB LA+RPV LA (DRUG).
Who is sponsoring clinical trial NCT04001803?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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