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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00035893
Recruitment Status : Completed
First Posted : May 7, 2002
Last Update Posted : April 17, 2013
Information provided by (Responsible Party):
AIM ImmunoTech Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Seropositivity HIV Infection Drug: poly I-poly C12U Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : May 2001
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00035893

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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
AIM ImmunoTech Inc.
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Study Director: David R Strayer, MD AIM ImmunoTech Inc.

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Responsible Party: AIM ImmunoTech Inc. Identifier: NCT00035893    
Other Study ID Numbers: AMP 720
First Posted: May 7, 2002    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013
Keywords provided by AIM ImmunoTech Inc.:
treatment interruption
HIV Infections
Additional relevant MeSH terms:
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HIV Infections
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Poly I-C
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs