Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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.

Trial Profile

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.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 23 Jan 2020

At a glance

  • Drugs Interferon alpha-n3 (Primary)
  • Indications Severe acute respiratory syndrome
  • Focus Therapeutic Use
  • Sponsors AIM ImmunoTech; Hemispherx Biopharma
  • Most Recent Events

    • 13 Apr 2010 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
    • 26 Oct 2005 New trial record.

Trial Overview

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.

Comments

This trial is entitled "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." It investigated the efficacy and tolerability of rintatolimod in patients with HIV-1 infection who were being treated with HAART. Results have been published.

Primary Endpoints

HAART-free time interval

description: To evaluate the potential effectiveness of Ampligen to increase the HAART-free time interval before HIV rebound during the STI of HAART.
time_frame: HAART adherence questionnaire completed weekly

Other Endpoints

CD4+ cell count
CD8+ cell count
Duration of virological response
Patient compliance
Quality of life
Viral load

Diseases Treated

Indication Qualifiers Patient Segments
Severe acute respiratory syndrome treatment -

Subjects

  • Subject Type patients & volunteers
  • Number

    Planned: 120

    Actual: 40

  • Sex male & female
  • Age Group ≥ 18 years; adult; elderly

Patient Inclusion Criteria

At least 18 years of age; CD4 cell count of greater than 400 cells; plasma HIV-1 RNA less than 50 copies/mL on two occasions: one within the six weeks prior to starting Baseline and the other during Baseline; history of virological success with suppression of HIV RNA level below 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 highly active antiretroviral therapy (HAART) regimen; 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 greater than 50, but less than 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: haemoglobin greater than 9.2 g/dL for men and greater than 8.9 g/dL for women; neutrophil count greater than 1000; platelet count greater than 75,000; aspartate/alanine transaminase less than 4.0 x upper limit of normal (ULN); serum creatinine less than 1.5 x ULN or a creatinine clearance greater than 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 randomisation (females of child bearing potential agree to use an effective means of contraception); completed any elective routine immunisations (including influenza vaccination) eight or more weeks prior to first dose of study drug.

Patient Exclusion Criteria

Active malignancy or history of malignancy other than minimal Kaposi sarcoma or basal cell carcinoma; inadequately controlled seizure disorder, history of AIDS, prior mismatched double-stranded RNA therapy (rintatolimod).

Trial Details

Identifiers

Identifier Owner
NCT00035893 ClinicalTrials.gov: US National Institutes of Health
AMP720 -

Organisations

  • Sponsors AIM ImmunoTech; Hemispherx Biopharma
  • Affiliations AIM ImmunoTech; Hemispherx Biopharma

Trial Dates

  • Initiation Dates

    Actual : 01 May 2001

  • Primary Completion Dates

    Actual : 01 Aug 2006

  • End Dates

    Actual : 01 Aug 2006

Other Details

  • Design multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location USA
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
Interferon alpha-n3Primary Drug
-
-

Controls

Rintatolimod

Rintatolimod (Dosage: 400 mg/dose; Route: IV; Frequency: 2/week; Duration: not clearly stated; Brand: Ampligen)

Results

Therapeutic efficacy

Administration of mismatched double-stranded RNA was associated with median 15 weeks without significant viral rebound, compared with 7 weeks with no administration, among HIV infected patients on structured treatment interruption from HAART. [1]
In patients with HIV-1 infection undergoing structured interruption of antiretroviral therapy, the use of mismatched double-stranded RNA during the interruption was associated with a longer duration without viral rebound (median ≥15 weeks) compared with controls (median 7 weeks). CD8+ cell counts significantly increased in patients who received mismatched double-stranded RNA, but not in controls. [2]

Adverse events

Mismatched double-stranded RNA was well tolerated in patients with HIV-1 infection. Adverse events were self-limiting and mild, and no effects on lipid levels, lactic acid or insulin resistance were observed. [2]

Publications

  1. Hemispherx Biopharma Inc. Hemispherx Presents New Data from Phase IIB Clinical Trial of RNA-based Ampligen(R) for Structured Treatment Interruption in HIV at DART Conference. Media-Rel 2002;.

    Media Release
  2. Mitchell W, Blick G, Strayer D, CARTER W, AMP 720 Investigators, et al. A phase IIB prospective, randomized, controlled study evaluating AMPLIGEN during structured treatment interruption of HAART in HIV infection. Antiviral-Res 2003;5741.

Authors

Author Total Publications First Author Last Author
AMP 720 Investigators 1 - -
Blick G 1 - -
CARTER W 1 - -
et al. 1 - 1
Hemispherx Biopharma Inc 1 1 1
Mitchell W 1 1 -
Strayer D 1 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Strayer DR Hemispherx Biopharma
-

Centres

Centre Name Location Trial Centre Country
AIM ImmunoTech
-
-
Allied Clinical Trials Miami, Florida USA
AltaMed Health Services Corporation Los Angeles, California USA
Christopher Lucasti, D.O. Somers Point, New Jersey USA
Circle Medical Center Norwalk, Connecticut USA
Dupont Circle Physicians Group Washington, District of Columbia USA
Hemispherx Biopharma
-
-
Julia Torres, MD Fort Lauderdale, Florida USA
Orange County Center for Special Immunology Fountain Valley, California USA
Scott Ubillos, MD Tampa, Florida USA
St. Michael's Medical Center Newark, New Jersey USA
W. Chris Woodward, DO Reading, Pennsylvania USA

Trial History

Event Date Event Type Comment
23 Jan 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 23 Jan 2020
23 Aug 2019 Other trial event According to an AIM ImmunoTech media release, the company has changed its name to AIM ImmunoTech, with effective from 3rd Sep 2019. Updated 16 Jan 2020
13 Apr 2010 Status change - completed Status changed from recruiting to completed as reported by ClinicalTrials.gov record. Updated 13 Apr 2010
26 Oct 2005 New trial record New trial record. Updated 26 Oct 2005

References

  1. Hemispherx Biopharma Inc. Hemispherx Presents New Data from Phase IIB Clinical Trial of RNA-based Ampligen(R) for Structured Treatment Interruption in HIV at DART Conference. Media-Rel 2002;.

    Media Release
  2. Mitchell W, Blick G, Strayer D, CARTER W, AMP 720 Investigators, et al. A phase IIB prospective, randomized, controlled study evaluating AMPLIGEN during structured treatment interruption of HAART in HIV infection. Antiviral-Res 2003;5741.

  3. Hemispherx Biopharma. Pharm-Biotech-Companies 2005;.

    Available from: URL: http://www.hemispherx.net
  4. Hemispherx Biopharma. Hemispherx Biopharma, Inc. Changes Name to AIM ImmunoTech Inc. Reflecting Ampligen's(Rm) Immuno Modulation Progress in Ongoing Oncology Clinical Trials and ME/CFS. Media-Rel 2019;.

    Media Release
  5. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
Back to top