A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)

A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)

The objective is to determine the effect of Isoprinosine (inosine pranobex) in homosexual male patients with AIDS related complex (ARC) in delaying the onset of AIDS. Secondly, to determine the effect of Isoprinosine in decreasing the severity and/or incidence of lesser opportunistic infections and/or other conditions associated with ARC.

Exclusion Criteria

Concurrent Medication:

Excluded:

• Cardiac glycosides.

Patients with the following are excluded:

• AIDS.
• Presenting with chronic candida infection-colo/rectal, oral/pharyngeal, cutaneous (finger/toenails) - for = or > 3 months who have not responded to therapy.
• Critical illness.
• Hemophilia.

Prior Medication:

Excluded within 1 month of study entry:

• Steroids.
• Cytotoxic immunosuppressive agents.
• Radiotherapy and/or systemic antiviral medication.
• Immunomodulators (including Isoprinosine).

Prior Treatment:

Excluded within 1 month of study entry:

• Radiotherapy.

History of gout, uric acid urolithiasis, uric acid nephrolithiasis, or renal dysfunction.

• Lymphoid malignancy.

Homosexual male patients with AIDS related complex (ARC).

Current IV drug abuse.