A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen - Full Text View

Purpose

To evaluate ampligen at two dosage levels given twice weekly in combination with zidovudine (AZT) versus AZT alone in individuals with HIV-related immune dysfunction defined as T4 count between 100 and 300 cells/mm3.

Condition	Intervention
HIV Infections	Drug: Ampligen Drug: Zidovudine

MedlinePlus related topics:

AIDS

ChemIDplus related topics:

Zidovudine Ampligen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind

Official Title:	A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen

Eligibility

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

Criteria

Inclusion Criteria

Patients must have:

HIV-1 seropositivity.
Absolute number of T4 cells 100-300 cells/mm3.
Given informed consent.
Zidovudine (AZT) therapy for 6 months prior to study entry.
At least one of the listed HIV-related clinical symptoms or opportunistic infections:
weight loss > 10 percent, unexplained diarrhea, unexplained intermittent fever, oral candidiasis > 1 month, decreased Karnofsky, oral hairy leukoplakia, chronic fatigue.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Evidence of AIDS.
Intercurrent acute medical disorder.

Concurrent Medication:

Excluded:

Chemotherapy for Kaposi's sarcoma (KS).
Aspirin.
Non-steroidal anti-inflammatory drugs.

Patients with the following are excluded:

Inability to return for treatment and evaluation for 12 months.
Intercurrent acute medical disorder.
Evidence of AIDS.
Receiving chemotherapy for Kaposi's sarcoma (KS).
Unwilling or unable to give informed consent.

Required:

Zidovudine (AZT).

Required at least 6 months prior to study entry:

Zidovudine (AZT).

Active drug abuse.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002269

Locations


United States, Florida
	Miami Veterans Administration Med Ctr
	Miami, Florida, United States, 33125

United States, Oregon
	Oregon Health Sciences Univ
	Portland, Oregon, United States, 97201

United States, Pennsylvania
	MCP Hahnemann Univ Hosp
	Philadelphia, Pennsylvania, United States, 19102

United States, Texas
	Nelson Tebedo Community Clinic
	Dallas, Texas, United States, 75219
	Dr Patricia Salvato
	Houston, Texas, United States, 77054

Sponsors and Collaborators

HEM Research

More Information

Study ID Numbers:	073A, AMP-700
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002269
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Acquired Immunodeficiency Syndrome

ampligen

AIDS-Related Complex

Zidovudine

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Zidovudine

AIDS-Related Complex

Retroviridae Infections

Immunologic Deficiency Syndromes

Ampligen

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 16, 2008

Sponsored by:	HEM Research
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002269