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NCT00035581 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART
A Phase 2 study, sponsored by AIM ImmunoTech.
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT00035581: Clinical Trial Phase 2 study, sponsored by AIM ImmunoTech.
NCT00035581 is a Phase 2 study that was terminated before completion, run by AIM ImmunoTech. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00035581, a Phase 2 study, was terminated before completion, sponsored by AIM ImmunoTech.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to "HAART" in HIV infected patients with CD4 counts \>300 and HIV-1 plasma RNA \>500 and \<30,000 copies/ml (PCR).
Primary Outcome
Evaluate the effects of adding Ampligen (or no Ampligen) to "HAART" in HIV+ patients for evidence of reductions in HIV-1 viral load in plasma using Roche Amplicor assay.
Interventions
- DRUG poly I-poly C12U
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2001-05 |
| Est. Completion | 2005-09 |
| Phase | Phase 2 |
Why NCT00035581 stopped before completion
NCT00035581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which poly I-poly C12U is the first listed.
NCT00035581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00035581 about?
NCT00035581 is a clinical study titled "Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART". This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to "HAART" in HIV infected patients with CD4 counts \>300 and HIV-1 plasma RNA \>500 and \<30,000 copies/ml (PCR).
What is the current status of trial NCT00035581?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2001-05. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00035581?
The interventions under investigation include: poly I-poly C12U (DRUG).
Who is sponsoring clinical trial NCT00035581?
This trial is sponsored by AIM ImmunoTech, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00035581's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 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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