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: (Ampligen) polyI-polyC12U	Phase II

MedlinePlus related topics:

AIDS

Drug Information available for:

Ampligen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

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.

Further study details as provided by Hemispherx Biopharma:

Estimated Enrollment:	120
Study Start Date:	April 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 > 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

Contacts


Contact: Judith Faith	215-988-0080 ext 127	judy@hemispherx.net

Locations


United States, California
	Orange County Center for Special Immunology	Recruiting
	Fountain Valley, California, United States, 92708
	Contact: Sandy Cassarella 714-751-5800 ext 26
	Principal Investigator: Paul J Cimoch, MD
	AltaMed Health Services Corporation	Recruiting
	Los Angeles, California, United States, 90022
	Contact: Rebecca Gonzalez 323-869-5450
	Principal Investigator: Daniel Pearce

United States, Connecticut
	Circle Medical Center	Recruiting
	Norwalk, Connecticut, United States, 06851
	Contact: Zaadia Arzu 203-852-9525
	Principal Investigator: Gary Blick, MD

United States, District of Columbia
	Dupont Circle Physicians Group	Recruiting
	Washington, District of Columbia, United States, 20009
	Contact: Linda Green 202-745-0201
	Principal Investigator: Douglas Ward, MD

United States, Florida
	Julia Torres, MD	Recruiting
	Fort Lauderdale, Florida, United States, 33306
	Contact: Miguel Brito 954-568-2929
	Principal Investigator: Julia Torres, MD
	Scott Ubillos, MD	Recruiting
	Tampa, Florida, United States, 33607
	Contact: Jennifer Bailey 813-870-4760
	Principal Investigator: Scott Ubillos, MD
	Allied Clinical Trials	Recruiting
	Miami, Florida, United States, 33156
	Contact: Alan Jacobson, Ph.D. 305-595-1616
	Principal Investigator: Alan Jocobson, Ph.D.

United States, New Jersey
	St. Michael's Medical Center	Recruiting
	Newark, New Jersey, United States, 07102
	Contact: Jim Fallone 973-877-2663
	Principal Investigator: Jihad Slim, MD
	Christopher Lucasti, D.O.	Recruiting
	Somers Point, New Jersey, United States, 08244
	Contact: Kelly Freeman 609-927-6662
	Contact: Sherry Jurasinski 609-927-2942
	Principal Investigator: Christopher Lucasti, D.O.

United States, Pennsylvania
	W. Chris Woodward, DO	Recruiting
	Reading, Pennsylvania, United States, 19601
	Contact: Juanita Goodwin 610-378-2552
	Principal Investigator: W. Chris Woodward, DO

Sponsors and Collaborators

Hemispherx Biopharma

More Information

Study ID Numbers:	AMP 720
First Received:	May 6, 2002
Last Updated:	September 23, 2005
ClinicalTrials.gov Identifier:	NCT00035893
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hemispherx Biopharma:

treatment interruption

HIV Infections

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Seropositivity

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Ampligen

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Therapeutic Uses

Lentivirus Infections

Infection

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Hemispherx Biopharma
Information provided by:	Hemispherx Biopharma
ClinicalTrials.gov Identifier:	NCT00035893