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NCT00613379 · ClinicalTrials.gov registry record · Phase 2
PRO 140 by IV Administration in Adults With HIV-1 Infection
A Phase 2 study, sponsored by CytoDyn.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00613379: Completed Phase 2 study, sponsored by CytoDyn.
NCT00613379 is a Phase 2 study that has completed, run by CytoDyn. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00613379, a Phase 2 study, has completed, sponsored by CytoDyn.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is: 1. To assess and characterize the PK and PD of PRO 140 administered IV 2. To assess the antiviral activity of PRO 140 3. To assess the safety and tolerability of PRO 140
Primary Outcome
The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection \[LLD\] = 48 copies/mL).
Interventions
- DRUG Placebo
- DRUG PRO 140
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-12 |
| Est. Completion | 2008-08 |
| Phase | Phase 2 |
What the finished NCT00613379 record still lists
NCT00613379 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00613379 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00613379 about?
NCT00613379 is a clinical study titled "PRO 140 by IV Administration in Adults With HIV-1 Infection". The purpose of this study is: 1. To assess and characterize the PK and PD of PRO 140 administered IV 2. To assess the antiviral activity of PRO 140 3. To assess the safety and tolerability of PRO 140
What is the current status of trial NCT00613379?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2007-12. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00613379?
The interventions under investigation include: Placebo (DRUG), PRO 140 (DRUG).
Who is sponsoring clinical trial NCT00613379?
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 NCT00613379's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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