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NCT00035893 · ClinicalTrials.gov registry record · Phase 2
The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART
A Phase 2 study of HIV Infection and HIV Seropositivity, sponsored by AIM ImmunoTech.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 10
- Study locations
NCT00035893: Completed Phase 2 study of HIV Infection and HIV Seropositivity, sponsored by AIM ImmunoTech.
NCT00035893 is a Phase 2 study of HIV Infection and HIV Seropositivity that has completed, run by AIM ImmunoTech. The registered enrollment target is 40 participants, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (83% lower). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00035893, a Phase 2 study of HIV Infection and HIV Seropositivity, has completed, sponsored by AIM ImmunoTech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 10
- Study locations
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 a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA \< 50 copies/ml (PCR) and CD4 levels \> 400.
Primary Outcome
To evaluate the potential effectiveness of Ampligen to increase the HAART-free time interval before HIV rebound during the STI of HAART.
Conditions Studied
Interventions
- DRUG poly I-poly C12U
Study Locations (10)
Florida
- Julia Torres, MD - Fort Lauderdale
- Allied Clinical Trials - Miami
- Scott Ubillos, MD - Tampa
California
- Orange County Center for Special Immunology - Fountain Valley
- AltaMed Health Services Corporation - Los Angeles
New Jersey
- St. Michael's Medical Center - Newark
- Christopher Lucasti, D.O. - Somers Point
Connecticut
- Circle Medical Center - Norwalk
District of Columbia
- Dupont Circle Physicians Group - Washington D.C.
Pennsylvania
- W. Chris Woodward, DO - Reading
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2001-05 |
| Est. Completion | 2006-08 |
| Phase | Phase 2 |
What the finished NCT00035893 record still lists
NCT00035893 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with HIV Infection appearing as the primary indexed condition, and to 1 intervention - of which poly I-poly C12U is the first listed.
NCT00035893 lists 10 locations in 6 states (Florida, California, New Jersey).
Frequently Asked Questions
What is clinical trial NCT00035893 about?
NCT00035893 is a clinical study titled "The Role of Ampligen in Strategic Therapeutic Intervention (STI) of 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 a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA \< 50 copies/ml (PCR) and CD4 levels \> 400...
What is the current status of trial NCT00035893?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2001-05. Estimated completion is 2006-08.
What conditions does trial NCT00035893 study?
This clinical trial studies the following conditions: HIV Infection, HIV Seropositivity.
What interventions are being tested in trial NCT00035893?
The interventions under investigation include: poly I-poly C12U (DRUG).
Who is sponsoring clinical trial NCT00035893?
This trial is sponsored by AIM ImmunoTech, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00035893 being conducted?
This trial has 10 study locations across California, Connecticut, District of Columbia, Florida, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00035893's enrollment target sits among peer trials
40 45th of 73 higher than 28 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infection 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.
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