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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ 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.


Enrollment: 16
Study Start Date: May 2001
Study Completion Date: September 2005
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 Names:
  • Ampligen
  • Rintatolimod
No Intervention: No Ampligen
No Ampligen administered for first 24 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
HIV Seropositivity
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014