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NCT02175680 · ClinicalTrials.gov registry record · Phase 2
Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection
A Phase 2 study, sponsored by CytoDyn.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT02175680: Completed Phase 2 study, sponsored by CytoDyn.
NCT02175680 is a Phase 2 study that has completed, run by CytoDyn. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02175680, a Phase 2 study, has completed, sponsored by CytoDyn.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy. Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment, and one week overlap at the end of the treatment in subjects who do not experience virologic failure.
Primary Outcome
Time to virologic failure after initiating PRO 140 monotherapy. Virologic failure was defined as two (2) consecutive HIV-1 RNA levels of ≥ 400 copies/mL.
Interventions
- DRUG PRO 140
- OTHER Historical data
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2014-04-16 |
| Est. Completion | 2015-02-02 |
| Phase | Phase 2 |
What the finished NCT02175680 record still lists
NCT02175680 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which PRO 140 is the first listed.
NCT02175680 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02175680 about?
NCT02175680 is a clinical study titled "Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection". This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy. Consenting subjects will be shifted from their combination antiretroviral regi...
What is the current status of trial NCT02175680?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2014-04-16. Estimated completion is 2015-02-02.
What interventions are being tested in trial NCT02175680?
The interventions under investigation include: PRO 140 (DRUG), Historical data (OTHER).
Who is sponsoring clinical trial NCT02175680?
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 NCT02175680's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 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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