The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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.

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Hemispherx Biopharma:

Primary Outcome Measures:

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.

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 Names: Ampligen Rintatolimod
No Intervention: No Ampligen No Ampligen administered for first 64 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Adults at least 18 years of age.
CD4 cell count of > 400 cells.
Plasma HIV-1 RNA < 50 copies/ml on two occasions: one within the six weeks prior to starting Baseline and the other during Baseline.
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

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

No publications provided

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
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hemispherx Biopharma:

treatment interruption
HIV Infections

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

Slow Virus Diseases
Poly I-C
Ampligen
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013