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NCT02483078 · ClinicalTrials.gov registry record · Phase 2
Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140
A Phase 2 study, sponsored by CytoDyn.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT02483078: Completed Phase 2 study, sponsored by CytoDyn.
NCT02483078 is a Phase 2 study that has completed, run by CytoDyn. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02483078, a Phase 2 study, has completed, sponsored by CytoDyn.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
This is a Phase 2b/3, multi-center, two part study, designed to evaluate the efficacy, safety, and tolerability of PRO 140 in conjunction with existing ART (failing regimen) for one week and Optimized Background Therapy (OBT) for 24 weeks respectively. Study population includes treatment-experienced HIV-infected patients with CCR5-tropic virus who demonstrates evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic or phenotypic resistance to ART drugs within three drug classes (or within two or more drug classes with limited treatment options).The options may be limited as a result of drug antiviral class cross-resistance or documented treatment intolerance.
Primary Outcome
The primary efficacy endpoint will be proportion of participants with a 0.5 log10 or greater reduction in HIV-1 RNA viral load from baseline at the end of the one week double-blind treatment period (Part 1).
Interventions
- DRUG Placebo
- DRUG PRO 140
- DRUG Optimized Background Regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2015-10 |
| Est. Completion | 2018-07 |
| Phase | Phase 2 |
What the finished NCT02483078 record still lists
NCT02483078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02483078 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02483078 about?
NCT02483078 is a clinical study titled "Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140". This is a Phase 2b/3, multi-center, two part study, designed to evaluate the efficacy, safety, and tolerability of PRO 140 in conjunction with existing ART (failing regimen) for one week and Optimized Background Therapy (OBT) for 24 weeks respectively. Study population includes treatment-experienced...
What is the current status of trial NCT02483078?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2015-10. Estimated completion is 2018-07.
What interventions are being tested in trial NCT02483078?
The interventions under investigation include: Placebo (DRUG), PRO 140 (DRUG), Optimized Background Regimen (DRUG).
Who is sponsoring clinical trial NCT02483078?
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 NCT02483078's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 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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