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.

Study Overview

• Status: Completed
• Conditions: HIV Infection; HIV Seropositivity
• Intervention / Treatment: Drug: poly I-poly C12U

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Orange County Center for Special Immunology
    • Los Angeles, California, United States, 90022
      • AltaMed Health Services Corporation
  • Connecticut
    • Norwalk, Connecticut, United States, 06851
      • Circle Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20009
      • Dupont Circle Physicians Group
  • Florida
    • Fort Lauderdale, Florida, United States, 33306
      • Julia Torres, MD
    • Miami, Florida, United States, 33156
      • Allied Clinical Trials
    • Tampa, Florida, United States, 33607
      • Scott Ubillos, MD
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • St. Michael's Medical Center
    • Somers Point, New Jersey, United States, 08244
      • Christopher Lucasti, D.O.
  • Pennsylvania
    • Reading, Pennsylvania, United States, 19601
      • W. Chris Woodward, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HAART-free time interval	To evaluate the potential effectiveness of Ampligen to increase the HAART-free time interval before HIV rebound during the STI of HAART.	HAART adherence questionnaire completed weekly

Collaborators and Investigators

• Sponsor: AIM ImmunoTech Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2001
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: May 6, 2002
• First Submitted That Met QC Criteria: May 6, 2002
• First Posted (Estimate): May 7, 2002

Study Record Updates

• Last Update Posted (Estimate): April 17, 2013
• Last Update Submitted That Met QC Criteria: April 16, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: HIV Infections; treatment interruption
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Immunologic Factors; Interferon Inducers; Poly I-C; poly(I).poly(c12,U)
• Other Study ID Numbers: AMP 720