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NCT05271370 · ClinicalTrials.gov registry record · Phase 2
An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study
A Phase 2 study, sponsored by CytoDyn.
- Terminated
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT05271370 is a Phase 2 study that was terminated before completion, run by CytoDyn. The registered enrollment target is 56 participants.
The verdict
NCT05271370, a Phase 2 study, was terminated before completion, sponsored by CytoDyn.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
This study is a Phase 2b/3 multi-center extension study designed to evaluate the long term antiviral activity, safety, and tolerability of the strategy of continuing PRO 140 350mg, 525mg, or 700mg SC (subcutaneous) monotherapy to maintain viral suppression after initial 48 weeks in virologically suppressed subjects. Consenting subjects will continue weekly PRO 140 350mg, 525mg, or 700mg monotherapy during the Treatment Extension Phase with the one-week overlap of existing retroviral regimen and PRO 140 350mg, 525mg, or 700 mg at the end of the treatment in subjects who do not experience virologic failure.
Interventions
- DRUG PRO 140 350
- DRUG PRO 140 525
- DRUG PRO 140 700
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2017-08-29 |
| Est. Completion | 2022-07-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05271370
The ClinicalTrials.gov registry entry for NCT05271370 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CytoDyn, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which PRO 140 350 is the first listed.
NCT05271370 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05271370 about?
NCT05271370 is a clinical study titled "An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study". This study is a Phase 2b/3 multi-center extension study designed to evaluate the long term antiviral activity, safety, and tolerability of the strategy of continuing PRO 140 350mg, 525mg, or 700mg SC (subcutaneous) monotherapy to maintain viral suppression after initial 48 weeks in virologically sup...
What is the current status of trial NCT05271370?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2017-08-29. Estimated completion is 2022-07-10.
What interventions are being tested in trial NCT05271370?
The interventions under investigation include: PRO 140 350 (DRUG), PRO 140 525 (DRUG), PRO 140 700 (DRUG).
Who is sponsoring clinical trial NCT05271370?
This trial is sponsored by CytoDyn, which has 18 total clinical trials registered on ClinicalTrials.gov.
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