Safety and Efficacy of Ampligen in the Treatment of HIV Patients Failing HAART - Full Text View

Sponsor:	Hemispherx Biopharma
Information provided by:	Hemispherx Biopharma
ClinicalTrials.gov Identifier:	NCT00035581

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 "HAART" in HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml (PCR).

Condition	Intervention	Phase
HIV Seropositivity HIV Infection	Drug: (Ampligen) polyI-polyC12U	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multi-Center, Randomized, Controlled Study of the Biological Actions of Ampligen as an Adjunct to HAART in HIV Disease

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ampligen

U.S. FDA Resources

Further study details as provided by Hemispherx Biopharma:

Estimated Enrollment:	130
Study Start Date:	July 2001

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 >300 cells.
HIV-1 plasma RNA >500 and <30,000 copies/ml.

A qualifying ("screening") HIV-1 RNA level >500 and <30,000 copies/ml must be documented at least once within 40 days prior to starting Baseline while patient is receiving a HAART regimen containing at least two of the following antiretroviral drugs:
- Abacavir (Ziagen)
- Zidovudine (Retrovir) AZT
- Zalcitabine (Hivid) ddC
- Didanosine (Videx) ddI
- Stavudine (Zerit) d4T
- Efavirenz (Sustiva)
- Indinavir (Crixivan)
- Ritonavir (Norvir)
- Nelfinavir (Viracept)
- Amprenavir (Agenerase)
The patient must have been taking this HAART regimen for four months or longer at the time of the qualifying HIV-1 RNA determination.
History of prior treatment (including the current HAART regimen) with at least one protease inhibitor (PI) and at least two nucleoside reverse transcriptase inhibitors (NRTI) and/or at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) and at least two nucleoside reverse transcriptase inhibitors (NRTI).
Karnofsky performance status of at least 70.
The following laboratory parameters within 14 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.
For females with child bearing potential: A negative serum pregnancy test within 14 days prior to randomization. Males and females of child bearing potential agree to use an effective means of contraception.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035581

Locations

United States, California
Orange County Center for Special Immunology
Fountain Valley, California, United States, 92708
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
Scott Ubillos, MD
Tampa, Florida, United States, 33607
United States, New Jersey
St. Michael's Medical Center
Newark, New Jersey, United States, 07102
United States, Pennsylvania
W. Chris Woodward, DO
Reading, Pennsylvania, United States, 19601

Sponsors and Collaborators

Hemispherx Biopharma

More Information

No publications provided

Responsible Party:	Hemisoherx Biopharma, Inc.
ClinicalTrials.gov Identifier:	NCT00035581 History of Changes
Other Study ID Numbers:	AMP 719
Study First Received:	May 3, 2002
Last Updated:	April 8, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hemispherx Biopharma:

treatment experienced
HIV Infections
HIV
HAART
early virologic failure

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
Ampligen
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012