The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease

A Multi-Center Randomized Double-Blind Placebo-Controlled Study to Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy

The objective of this Phase III, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of Isoprinosine in producing an immuno-restorative response within the study observation period (including the 2-month period following cessation of the 28 days of treatment), measured by one or more of the following immunological parameters:

• Increase in natural killer (NK) cell activity.
• Increase in total T-cells (OKT-11).
• Increases in absolute number and percentage of T-helper cells (OKT-4).

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

• History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction and severe gastric ulcer.
• Lymphoid malignancy.
• Infectious mononucleosis caused by cytomegalovirus or Epstein-Barr virus.
• Heart disease (especially if receiving cardiac glycosides).
• Hemophilia.

Patients with the following are excluded:

• Kaposi's sarcoma or overt opportunistic infections as follows:
• Candida albicans, Pneumocystis carinii, Herpes simplex, Cryptococcus neoformans, Histoplasma capsulatum, Mycobacterium avium-intracellulare, Toxoplasma gondii, Legionella, Cryptosporidium, Isospora, and Papovavirus.
• Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophil test (EBV) or cell culture (CMV).
• History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer.
• Critical illness.
• Condition requiring hospitalization.
• Women of childbearing age are excluded.
• Hemophilia.

Prior Medication:

Excluded:

• Steroids.
• Cytotoxic immunosuppressive agents.
• Antiviral medicine.

Prior Treatment:

Excluded:

• Radiotherapy.

Patients who have unexplained immunodepression and are at risk of developing AIDS.

• Patients with prolonged generalized lymphadenopathy for 3 or more months (greater than 1 cm at two or more noncontiguous sites).

IV drug abuse.