- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002269
A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen
June 23, 2005 updated by: HEM Research
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.
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Miami, Florida, United States, 33125
- Miami Veterans Administration Med Ctr
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Oregon
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Portland, Oregon, United States, 97201
- Oregon Health Sciences Univ
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19102
- MCP Hahnemann Univ Hosp
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Texas
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Dallas, Texas, United States, 75219
- Nelson Tebedo Community Clinic
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Houston, Texas, United States, 77054
- Dr Patricia Salvato
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
August 1, 1991
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Zidovudine
- poly(I).poly(c12,U)
Other Study ID Numbers
- 073A
- AMP-700
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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