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The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART
NCT00035893 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00035893
The ClinicalTrials.gov registry entry for NCT00035893 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AIM ImmunoTech, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00035893 reports 10 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00035893?
The interventions under investigation include: poly I-poly C12U (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00035893?
This trial is sponsored by AIM ImmunoTech, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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