A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen

A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen

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.

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.