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

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

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

Study Type:	Interventional
Study Design:	Treatment, Double-Blind
Official Title:	A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine Ampligen

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	073A, AMP-700
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002269 History of Changes
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:

Antimetabolites
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Zidovudine
AIDS-Related Complex
Antiviral Agents
Immunologic Deficiency Syndromes

Ampligen
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections

Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Ampligen
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on July 06, 2009