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 July 19, 2018
    This information is provided by ClinicalTrials.gov.