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

May 6, 2002
April 16, 2013
May 2001
August 2006   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00035893 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Seropositivity
  • HIV Infection
Drug: poly I-poly C12U
200-400 mg IV infusions 2x/week for 64 weeks
Other Names:
  • Ampligen
  • Rintatolimod
  • Experimental: Ampligen
    Ampligen (poly I-poly C12U) 200-400 mg IV infusions given twice weekly for 64 weeks.
    Intervention: Drug: poly I-poly C12U
  • No Intervention: No Ampligen
    No Ampligen administered for first 64 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2006
August 2006   (final data collection date for primary outcome measure)
  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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00035893
AMP 720
No
Hemispherx Biopharma
Hemispherx Biopharma
Not Provided
Study Director: David R Strayer, MD Hemispherx Biopharma
Hemispherx Biopharma
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP