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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Hemispherx Biopharma
ClinicalTrials.gov Identifier:
NCT00035581
First received: May 3, 2002
Last updated: April 16, 2013
Last verified: April 2013

May 3, 2002
April 16, 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 ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00035581 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00035581
AMP 719
No
Hemispherx Biopharma
Hemispherx Biopharma
Not Provided
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