Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART

April 16, 2013 updated by: AIM ImmunoTech Inc.

A Multi-Center, Randomized, Controlled Study of the Biological Actions of Ampligen as an Adjunct to HAART in HIV Disease

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Orange County Center for Special Immunology
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • Circle Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • Dupont Circle Physicians Group
    • Florida
      • Fort Lauderdale, Florida, United States, 33306
        • Julia Torres, MD
      • Tampa, Florida, United States, 33607
        • Scott Ubillos, MD
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • St. Michael's Medical Center
    • Pennsylvania
      • Reading, Pennsylvania, United States, 19601
        • W. Chris Woodward, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  1. Adults at least 18 years of age.
  2. CD4 cell count of >300 cells.

  3. HIV-1 plasma RNA >500 and <30,000 copies/ml.

    A qualifying ("screening") HIV-1 RNA level >500 and <30,000 copies/ml must be documented at least once within 40 days prior to starting Baseline while patient is receiving a HAART regimen containing at least two of the following antiretroviral drugs:

    • Abacavir (Ziagen)
    • Zidovudine (Retrovir) AZT
    • Zalcitabine (Hivid) ddC
    • Didanosine (Videx) ddI
    • Stavudine (Zerit) d4T
    • Efavirenz (Sustiva)
    • Indinavir (Crixivan)
    • Ritonavir (Norvir)
    • Nelfinavir (Viracept)
    • Amprenavir (Agenerase)

    The patient must have been taking this HAART regimen for four months or longer at the time of the qualifying HIV-1 RNA determination.

  4. History of prior treatment (including the current HAART regimen) with at least one protease inhibitor (PI) and at least two nucleoside reverse transcriptase inhibitors (NRTI) and/or at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) and at least two nucleoside reverse transcriptase inhibitors (NRTI).
  5. Karnofsky performance status of at least 70.

  6. The following laboratory parameters within 14 days prior to treatment:

    • Hemoglobin > 9.2 g/dL for men and > 8.9 g/dL for women
    • Neutrophil count > 1000
    • Platelet count > 75,000
    • AST/ALT < 4.0 x upper limit of normal (ULN)
    • Serum creatinine < 1.5 x ULN or a creatinine clearance > 50 mL/min.
  7. For females with child bearing potential: A negative serum pregnancy test within 14 days prior to randomization. Males and females of child bearing potential agree to use an effective means of contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ampligen
Ampligen (polyI-polyC12U) 200-400 mg IV infusions given twice weekly for 24 weeks
Drug: poly I-poly C12U
200-400 mg IV infusions 2x/week for 24 weeks
Other Names:
  • Ampligen
  • Rintatolimod
No Intervention: No Ampligen
No Ampligen administered for first 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in HIV-1 Viral Load
Time Frame: 4, 8, 12, 16, 20 and 24
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.
4, 8, 12, 16, 20 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIM ImmunoTech Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

May 3, 2002

First Submitted That Met QC Criteria

May 3, 2002

First Posted (Estimate)

May 6, 2002

Study Record Updates

Last Update Posted (Estimate)

April 17, 2013

Last Update Submitted That Met QC Criteria

April 16, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMP 719

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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