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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: Clinical Trial Phase 2 study, sponsored by CytoDyn.
NCT05271370 is a Phase 2 study that was terminated before completion, run by CytoDyn. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Division of AIDS (DAIDS) grading table provides an adverse event severity grading scale ranging from grades 1 to 5 with descriptions for each adverse event based on the following general guidelines: * Grade 1 indicates a mild event * Grade 2 indicates a moderate event * Grade 3 indicates a severe event * Grade 4 indicates a potentially life-threatening event * Grade 5 indicates death (Note: This grade is not specifically listed on each page of the grading table). Treatment-Emergent Serious
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 |
Why NCT05271370 stopped before completion
NCT05271370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 3 interventions - of which PRO 140 350 is the first listed.
NCT05271370 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05271370's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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