A Study of Isoprinosine in Patients With Severe AIDS

A Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Severe Acquired Immunodeficiency Syndrome

To evaluate the effect of Isoprinosine in patients diagnosed as having AIDS relative to:

Laboratory (immunologic defects):

• Comparison of total helper and suppressor T-cell numbers among the groups.
• Comparison of changes in natural killer cell activity.
• Comparison of other laboratory findings among the groups.

Clinical changes:

• Comparison of the frequency of opportunistic infections among the groups.
• Comparison of the frequency of the development of AIDS-related malignancies.
• Comparison of other clinical manifestations relative to severity and time of onset.

Exclusion Criteria

Co-existing Condition:

Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer are excluded.

Concurrent Medication:

Excluded:

• Steroids.
• Cytotoxic immunosuppressive agents.
• Radiotherapy.

The following are excluded:

• Critically ill patients.
• Patients receiving steroids, cytotoxic immunosuppressive agents, radiotherapy.
• Patients who have received any other immunotherapy.
• Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.

Prior Medication:

Excluded:

• Any other immunotherapy.

Patients with severe AIDS and specified laboratory immunologic defects.