- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000735
A Clinical Trial To Evaluate the Toxicity and Antiviral Effects of a Range of Doses of Ampligen in p24 Antigen Positive HIV-Infected Patients With AIDS or ARC
Study Overview
Detailed Description
Ampligen is a suitable drug for clinical trials against HIV because it has been shown to stimulate the immune system and to inhibit replication of HIV in vitro at doses that can be achieved without noticeable harmful side effects.
Patients entered in the study are given ampligen by intravenous infusion at hemophilia treatment centers once during the first week of the trial and twice a week during the following 12 weeks. The dose each patient receives is determined by the responses of earlier patients. If the status of the HIV infection does not improve after the first 13 weeks, ampligen will be stopped. Each patient maintains a daily diary listing any symptoms or problems that occur such as headache, nausea, or change in appetite. Other anti-HIV drugs cannot be taken during the trial, and aspirin or acetaminophen should not be taken for more than 72 hours at any time during the trial without consulting the research staff. Blood will be drawn at intervals during the 13-week trial and 8-week follow-up and used to determine the effect of ampligen on HIV and the immune system as well as to monitor toxicity and side effects.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20037
- George Washington Univ Med Ctr
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Pennsylvania
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Hershey, Pennsylvania, United States, 170330850
- Milton S Hershey Med Ctr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Hemophiliacs are included. Patients must have:
- Consistently positive serum HIV p24 antigen (= or > 70 pg/ml) defined by the Abbott HIV antigen test. This demonstration must be seen on two occasions, each separated by at least 72 hours, the last of which must be within 2 weeks of starting therapy.
- Positive HIV antibody test.
Prior Medication:
Allowed:
- Acyclovir for short course (7 days).
- Ketoconazole for short course (7 days).
- Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
- Trimethoprim / sulfamethoxazole for PCP prophylaxis.
Exclusion Criteria
Co-existing Condition:
Patients with AIDS encephalopathy as a sole indicator are excluded.
Patients with AIDS encephalopathy as a sole indicator are excluded.
Prior Medication:
Excluded:
- Other experimental medication.
- Antineoplastic therapy.
- Amphotericin B.
- Ganciclovir.
- Excluded within 14 days of study entry:
- Biologic modifiers.
- Corticosteroids.
- Excluded within 30 days of study entry:
- Other antiretroviral agents.
- Excluded within 60 days of study entry:
- Ribavirin.
Active drug or alcohol abuse.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Masking: NONE
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
- HIV Seropositivity
- Anti-Infective Agents
- Antiviral Agents
- poly(I).poly(c12,U)
Other Study ID Numbers
- ACTG 054
- 11028 (DAIDS ES Registry Number)
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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