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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 is a Phase 2 study that has completed, run by CytoDyn. The registered enrollment target is 52 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02483078
The ClinicalTrials.gov registry entry for NCT02483078 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 52 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 Placebo is the first listed.
NCT02483078 reports 0 study locations.
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.
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