Search / 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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of May 26, 2024

Completed

Keywords

Virus Replication T Lymphocytes Infusions, Intravenous Immunologic Surveillance Acquired Immunodeficiency Syndrome Ampligen Aids Related Complex Antiviral Agents

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 wi...

Gender

All

Eligibility criteria

  • 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.

Attachments

readout_NCT00000735_2024-05-26.pdf

4.5 MB

NCT00000735_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Washington, District Of Columbia, United States

Hershey, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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