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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Hemispherx Biopharma


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
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 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
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.

Further study details as provided by Hemispherx Biopharma:

Primary Outcome Measures

  • 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.

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 Name:
  • Ampligen
  • Rintatolimod

No Intervention: No Ampligen
No Ampligen administered for first 64 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 > 400 cells.
  2. Plasma HIV-1 RNA < 50 copies/ml on two occasions: one within the six weeks prior to starting Baseline and the other during Baseline.
  3. 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.
  • Karnofsky performance status of at least 70.
  • 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.
  • Ability and willingness to give written informed consent.
  • 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.
  • 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

    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

    More Information


    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  

    Keywords provided by Hemispherx Biopharma:

    treatment interruption
    HIV Infections

    Additional relevant MeSH terms:
    HIV Infections
    HIV Seropositivity
    poly(I).poly(c12,U)
    Poly I-C

    ClinicalTrials.gov processed this data on October 19, 2017
    This information is provided by ClinicalTrials.gov.