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NCT00784147 · ClinicalTrials.gov registry record · Phase 2
Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1
A Phase 2 study, sponsored by TaiMed Biologics.
- Completed
- Registry status
- Phase 2
- Development phase
- 113
- Enrollment target
NCT00784147: Completed Phase 2 study, sponsored by TaiMed Biologics.
NCT00784147 is a Phase 2 study that has completed, run by TaiMed Biologics. The registered enrollment target is 113 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00784147, a Phase 2 study, has completed, sponsored by TaiMed Biologics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 113 participants
- Enrollment target
Study Summary
The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks. In addition to study drug, all patients will receive an optimized background regimen (OBR), which is a standard-of-care regimen selected by the investigator prior to randomization that is comprised of 2-4 antiretroviral agents. These agents must have been approved by the local regulatory agency or be available through expanded-access programs for treatment of human immunodeficiency virus (HIV).
Primary Outcome
For the primary efficacy analysis, "undetectable" was defined as having HIV-1 RNA below the limit of assay detection at \<50 copies/mL. The primary efficacy endpoint was analyzed using Fisher exact test. The primary analysis was performed using the ITT population and both the missing data equals treatment failure (MEF) and last observation carried forward (LOCF) methods. The more conservative MEF results are recorded here.
Interventions
- DRUG Ibalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2008-08 |
| Est. Completion | 2011-04 |
| Phase | Phase 2 |
What the finished NCT00784147 record still lists
NCT00784147 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 1 intervention - of which Ibalizumab is the first listed.
NCT00784147 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00784147 about?
NCT00784147 is a clinical study titled "Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1". The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks. In addition to study drug, all patients will receive an optimized background regimen (OBR), which is a standard-of-care regimen ...
What is the current status of trial NCT00784147?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 113 participants. The study started on 2008-08. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00784147?
The interventions under investigation include: Ibalizumab (DRUG).
Who is sponsoring clinical trial NCT00784147?
This trial is sponsored by TaiMed Biologics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00784147's enrollment target sits among peer trials
113 631st of 2000 higher than 1,370 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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