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Clinical Trials

MainTitle

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

This study has been terminated
Sponsor
Hemispherx Biopharma


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
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV Seropositivity
HIV Infection

Drug : poly I-poly C12U
Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Hemispherx Biopharma:

Primary Outcome Measures

  • 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.

Enrollment: 16
Study Start Date: May 2001
Study Completion Date: September 2005
Estimated Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name:
  • Ampligen
  • Rintatolimod

No Intervention: No Ampligen
No Ampligen administered for first 24 weeks
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

1. Adults at least 18 years of age.

  1. CD4 cell count of >300 cells.
  2. 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.
  • 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).
  • Karnofsky performance status of at least 70.
  • 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.
    • 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

      Contacts and Locations

      Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

      Please refer to this study by its ClinicalTrials.gov identifier: 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

      More Information


      Responsible Party: Hemispherx Biopharma  
      ClinicalTrials.gov Identifier: NCT00035581   History of Changes  
      Other Study ID Numbers: AMP 719  
      Study First Received: May 3, 2002  
      Last Updated: April 16, 2013  

      Keywords provided by Hemispherx Biopharma:

      treatment experienced
      HIV Infections
      HIV
      HAART
      early virologic failure

      Additional relevant MeSH terms:
      HIV Infections
      HIV Seropositivity
      poly(I).poly(c12,U)
      Poly I-C

      ClinicalTrials.gov processed this data on October 20, 2017
      This information is provided by ClinicalTrials.gov.