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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 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.

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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.

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

FieldValue
Enrollment Target 40 participants
Start Date 2001-05
Est. Completion 2006-08
Phase Phase 2

Sponsor

AIM ImmunoTech

5 total trials

What the Registry Record Tells You About NCT00035893

The ClinicalTrials.gov registry entry for NCT00035893 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (83% lower). The listed sponsor is AIM ImmunoTech, which has 5 total studies on file at ClinicalTrials.gov.

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 reports 10 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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