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NCT02859961 · ClinicalTrials.gov registry record · Phase 2
Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection
A Phase 2 study, sponsored by CytoDyn.
- Completed
- Registry status
- Phase 2
- Development phase
- 562
- Enrollment target
NCT02859961 is a Phase 2 study that has completed, run by CytoDyn. The registered enrollment target is 562 participants.
The verdict
NCT02859961, a Phase 2 study, has completed, sponsored by CytoDyn.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 562 participants
- Enrollment target
Study Summary
This study is a Phase 2b/3, multi-center study designed to evaluate the efficacy, safety, and tolerability of the strategy of shifting clinically stable patients receiving suppressive combination antiretroviral therapy to PRO 140 monotherapy and maintaining viral suppression for 48 weeks following study entry. Consenting patients will be shifted from combination antiretroviral regimen to weekly PRO 140 monotherapy for 48 weeks during the Treatment Phase with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment and also one week overlap at the end of the treatment in subjects who do not experience virologic failure.
Interventions
- DRUG PRO 140 (350 mg)
- DRUG PRO 140 (525 mg)
- DRUG PRO 140 (700 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 562 participants |
| Start Date | 2016-12-07 |
| Est. Completion | 2020-12-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02859961
The ClinicalTrials.gov registry entry for NCT02859961 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 562 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 mg) is the first listed.
NCT02859961 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02859961 about?
NCT02859961 is a clinical study titled "Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection". This study is a Phase 2b/3, multi-center study designed to evaluate the efficacy, safety, and tolerability of the strategy of shifting clinically stable patients receiving suppressive combination antiretroviral therapy to PRO 140 monotherapy and maintaining viral suppression for 48 weeks following s...
What is the current status of trial NCT02859961?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 562 participants. The study started on 2016-12-07. Estimated completion is 2020-12-07.
What interventions are being tested in trial NCT02859961?
The interventions under investigation include: PRO 140 (350 mg) (DRUG), PRO 140 (525 mg) (DRUG), PRO 140 (700 mg) (DRUG).
Who is sponsoring clinical trial NCT02859961?
This trial is sponsored by CytoDyn, which has 18 total clinical trials registered on ClinicalTrials.gov.
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