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The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART
This study is currently recruiting participants.
Verified by Hemispherx Biopharma, September 2005
First Received: May 6, 2002   Last Updated: September 23, 2005   History of Changes
Sponsor: Hemispherx Biopharma
Information provided by: Hemispherx Biopharma
ClinicalTrials.gov Identifier: NCT00035893
  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 a Strategic Therapeutic Intervention (STI) of HAART in patients with plasma HIV RNA < 50 copies/ml (PCR) and CD4 levels > 400.


Condition Intervention Phase
HIV Seropositivity
HIV Infection
Drug: (Ampligen) polyI-polyC12U
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: The Role of Ampligen in Strategic Therapeutic Intervention (STI) of Highly Active Anti-Retroviral Therapy (HAART): A Multi-Center, Randomized, Controlled Study of Ampligen Potentiation of the HAART-Free Interval.

Resource links provided by NLM:


Further study details as provided by Hemispherx Biopharma:

Estimated Enrollment: 120
Study Start Date: April 2001
  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 > 400 cells.
  3. Plasma HIV-1 RNA < 50 copies/ml on two occasions: one within the six weeks prior to starting Baseline and the other during Baseline.
  4. History of virologic success with suppression of HIV RNA level < 50 copies/ml during the last nine months documented a minimum of two times during the last ten months or a minimum of three times during the last fifteen months while patient is receiving a HAART regiment. During the four months prior to starting Baseline, continuing through Baseline and the 64 week study period, the HAART regimen must remain unchanged and contain at least one of the following ten anti-retroviral drugs:

    • Abacavir (Ziagen)
    • Zidovudine (Retrovir) AZT
    • Zalcitabine (Hivid) ddC
    • Didanosine (Videx) ddl
    • Stavudine (Zerit) d4T
    • Efavirenz (Sustiva)
    • Indinavir (Crixivan)
    • Ritonavir (Norvir)
    • Nelfinavir (Viracept)
    • Amprenavir (Agenerase)

    Only one HIV plasma RNA level > 50, but < 100 copies/ml is permitted during the four month period immediately prior to starting Baseline.

  5. Karnofsky performance status of at least 70.
  6. The following laboratory parameters within 21 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. Ability and willingness to give written informed consent.
  8. For females with child bearing potential: A negative serum pregnancy test within 14 days prior to randomization. Females of child bearing potential agree to use an effective means of contraception.
  9. The patient must have completed any elective routine immunizations (including influenza vaccination) eight or more weeks prior to first dose of study drug.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035893

Contacts
Contact: Judith Faith 215-988-0080 ext 127 judy@hemispherx.net

Locations
United States, California
Orange County Center for Special Immunology Recruiting
Fountain Valley, California, United States, 92708
Contact: Sandy Cassarella     714-751-5800 ext 26        
Principal Investigator: Paul J Cimoch, MD            
AltaMed Health Services Corporation Recruiting
Los Angeles, California, United States, 90022
Contact: Rebecca Gonzalez     323-869-5450        
Principal Investigator: Daniel Pearce            
United States, Connecticut
Circle Medical Center Recruiting
Norwalk, Connecticut, United States, 06851
Contact: Zaadia Arzu     203-852-9525        
Principal Investigator: Gary Blick, MD            
United States, District of Columbia
Dupont Circle Physicians Group Recruiting
Washington, District of Columbia, United States, 20009
Contact: Linda Green     202-745-0201        
Principal Investigator: Douglas Ward, MD            
United States, Florida
Julia Torres, MD Recruiting
Fort Lauderdale, Florida, United States, 33306
Contact: Miguel Brito     954-568-2929        
Principal Investigator: Julia Torres, MD            
Scott Ubillos, MD Recruiting
Tampa, Florida, United States, 33607
Contact: Jennifer Bailey     813-870-4760        
Principal Investigator: Scott Ubillos, MD            
Allied Clinical Trials Recruiting
Miami, Florida, United States, 33156
Contact: Alan Jacobson, Ph.D.     305-595-1616        
Principal Investigator: Alan Jocobson, Ph.D.            
United States, New Jersey
St. Michael's Medical Center Recruiting
Newark, New Jersey, United States, 07102
Contact: Jim Fallone     973-877-2663        
Principal Investigator: Jihad Slim, MD            
Christopher Lucasti, D.O. Recruiting
Somers Point, New Jersey, United States, 08244
Contact: Kelly Freeman     609-927-6662        
Contact: Sherry Jurasinski     609-927-2942        
Principal Investigator: Christopher Lucasti, D.O.            
United States, Pennsylvania
W. Chris Woodward, DO Recruiting
Reading, Pennsylvania, United States, 19601
Contact: Juanita Goodwin     610-378-2552        
Principal Investigator: W. Chris Woodward, DO            
Sponsors and Collaborators
Hemispherx Biopharma
  More Information

No publications provided

Study ID Numbers: AMP 720
Study First Received: May 6, 2002
Last Updated: September 23, 2005
ClinicalTrials.gov Identifier: NCT00035893     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Hemispherx Biopharma:
treatment interruption
HIV Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Ampligen
Virus Diseases
HIV Seropositivity
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 25, 2009