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. Identifier: NCT00035581
Recruitment Status : Terminated
First Posted : May 6, 2002
Last Update Posted : April 17, 2013
Information provided by (Responsible Party):
Hemispherx Biopharma

May 3, 2002
May 6, 2002
April 17, 2013
May 2001
September 2005   (Final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00035581 on Archive Site
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Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART
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).
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV Seropositivity
  • HIV Infection
Drug: poly I-poly C12U
200-400 mg IV infusions 2x/week for 24 weeks
Other Names:
  • Ampligen
  • Rintatolimod
  • Experimental: Ampligen
    Ampligen (polyI-polyC12U) 200-400 mg IV infusions given twice weekly for 24 weeks
    Intervention: Drug: poly I-poly C12U
  • No Intervention: No Ampligen
    No Ampligen administered for first 24 weeks
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2005
September 2005   (Final data collection date for primary outcome measure)
  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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
AMP 719
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Hemispherx Biopharma
Hemispherx Biopharma
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Study Director: David R Strayer, MD Hemispherx Biopharma
Hemispherx Biopharma
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP