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

• Status: Completed
• Trial end date: 1990-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Antiviral Agents; Poly I-C; poly(I).poly(c12,U)

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.