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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To determine the safety of intravenous infusion of ampligen in symptomatic HIV-infected patients at several dose levels, to determine the maximum dose that can be tolerated, and to measure the effects of ampligen on the HIV virus infection, immune function, and clinical condition. 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.

Key facts

Study ID

NCT00000735

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

12

Expected to finish

1990-02-01

Last updated by the study team

2021-11-03

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• Milton S Hershey Med Ctr — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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