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NCT02355184 · ClinicalTrials.gov registry record · Phase 2
An Extension of Protocol PRO 140_CD01 Study
A Phase 2 study, sponsored by CytoDyn.
- Terminated
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT02355184: Clinical Trial Phase 2 study, sponsored by CytoDyn.
NCT02355184 is a Phase 2 study that was terminated before completion, run by CytoDyn. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02355184, a Phase 2 study, was terminated before completion, sponsored by CytoDyn.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is an extension of Protocol PRO 140\_CD 01 to further evaluate the long-term suppression of HIV-1 replication following substitution of stable combination antiretroviral therapy with a PRO 140 (Monoclonal CCR5 antibody) monotherapy in adult subjects with HIV-1 infection
Primary Outcome
Virologic failure (VF) is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days. The time to VF will be compared to a historical data (i.e., time to HIV-1 RNA viral load \> 500 copies/mL of 29 days). The statistical comparison will be conducted using Wilcoxon rank sum test and the median time to Virologic Failure for this study will be compared to 30 days.
Interventions
- DRUG PRO 140 350mg weekly subcutaneous (SC) injection.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-11-18 |
| Est. Completion | 2022-07-15 |
| Phase | Phase 2 |
Why NCT02355184 stopped before completion
NCT02355184 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which PRO 140 350mg weekly subcutaneous (SC) injection. is the first listed.
NCT02355184 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02355184 about?
NCT02355184 is a clinical study titled "An Extension of Protocol PRO 140_CD01 Study". This is an extension of Protocol PRO 140\_CD 01 to further evaluate the long-term suppression of HIV-1 replication following substitution of stable combination antiretroviral therapy with a PRO 140 (Monoclonal CCR5 antibody) monotherapy in adult subjects with HIV-1 infection
What is the current status of trial NCT02355184?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2014-11-18. Estimated completion is 2022-07-15.
What interventions are being tested in trial NCT02355184?
The interventions under investigation include: PRO 140 350mg weekly subcutaneous (SC) injection. (DRUG).
Who is sponsoring clinical trial NCT02355184?
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 NCT02355184's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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