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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00035581
Recruitment Status : Terminated
First Posted : May 6, 2002
Last Update Posted : April 17, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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).

Condition or disease Intervention/treatment Phase
HIV Seropositivity HIV Infection Drug: poly I-poly C12U Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Controlled Study of the Biological Actions of Ampligen as an Adjunct to HAART in HIV Disease
Study Start Date : May 2001
Primary Completion Date : September 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035581


Locations
United States, California
Orange County Center for Special Immunology
Fountain Valley, California, United States, 92708
United States, Connecticut
Circle Medical Center
Norwalk, Connecticut, United States, 06851
United States, District of Columbia
Dupont Circle Physicians Group
Washington, District of Columbia, United States, 20009
United States, Florida
Julia Torres, MD
Fort Lauderdale, Florida, United States, 33306
Scott Ubillos, MD
Tampa, Florida, United States, 33607
United States, New Jersey
St. Michael's Medical Center
Newark, New Jersey, United States, 07102
United States, Pennsylvania
W. Chris Woodward, DO
Reading, Pennsylvania, United States, 19601
Sponsors and Collaborators
Hemispherx Biopharma
Investigators
Study Director: David R Strayer, MD Hemispherx Biopharma
More Information

Responsible Party: Hemispherx Biopharma
ClinicalTrials.gov Identifier: NCT00035581     History of Changes
Other Study ID Numbers: AMP 719
First Posted: May 6, 2002    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013

Keywords provided by Hemispherx Biopharma:
treatment experienced
HIV Infections
HIV
HAART
early virologic failure

Additional relevant MeSH terms:
HIV Infections
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
poly(I).poly(c12,U)
Poly I-C
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs