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The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hemispherx Biopharma
ClinicalTrials.gov Identifier:
NCT00035893
First received: May 6, 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 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: 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: 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:

Primary Outcome Measures:
  • HAART-free time interval [ Time Frame: HAART adherence questionnaire completed weekly ] [ Designated as safety issue: Yes ]
    To evaluate the potential effectiveness of Ampligen to increase the HAART-free time interval before HIV rebound during the STI of HAART.


Enrollment: 40
Study Start Date: May 2001
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ampligen
Ampligen (poly I-poly C12U) 200-400 mg IV infusions given twice weekly for 64 weeks.
Drug: poly I-poly C12U
200-400 mg IV infusions 2x/week for 64 weeks
Other Names:
  • Ampligen
  • Rintatolimod
No Intervention: No Ampligen
No Ampligen administered for first 64 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 > 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
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: NCT00035893

Locations
United States, California
Orange County Center for Special Immunology
Fountain Valley, California, United States, 92708
AltaMed Health Services Corporation
Los Angeles, California, United States, 90022
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
Allied Clinical Trials
Miami, Florida, United States, 33156
Scott Ubillos, MD
Tampa, Florida, United States, 33607
United States, New Jersey
St. Michael's Medical Center
Newark, New Jersey, United States, 07102
Christopher Lucasti, D.O.
Somers Point, New Jersey, United States, 08244
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: NCT00035893     History of Changes
Other Study ID Numbers: AMP 720
Study First Received: May 6, 2002
Last Updated: April 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Hemispherx Biopharma:
treatment interruption
HIV Infections

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
HIV Seropositivity
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Poly I-C
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Interferon Inducers
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014