A Study of Isoprinosine in Patients With Lymph Node Disease

A Multi-Center Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Unexplained Generalized Lymphadenopathy

The objectives of this study are to determine the effects of isoprinosine in patients diagnosed as having unexplained generalized lymphadenopathy. Variables to be examined will include:

Signs and symptoms:

• Lymphadenopathy.
• Fever.
• Weight loss.
• Occurrence of opportunistic infections.

Cell-mediated immune system parameters:

• T-helper cell (OKT4) numbers and proportions.
• T-suppressor cell (OKT8) numbers and proportions.
• Natural killer (NK) cell activity.
• Lymphocyte blastogenic response to phytohemagglutinin (PHA).
• Lymphocyte blastogenic response to pokeweed mitogen (PWM).
• Immunoglobulin (IgG, IgA, IgM, IgE, IgD) profile.
• Circulating immune complexes. Infections characteristically associated with AIDS, such as Candida albicans, Pneumocystis carinii pneumonia, Cytomegalovirus, Herpes simplex, Cryptococcus, Histoplasma, Toxoplasma, Cryptosporidium, Mycobacterium avium- intracellulare, Legionella, and Isospora.

Safety parameters:

• Blood chemistry including serum uric acid (PurposeA-12).
• Complete blood count (CBC).
• Platelet count.

Exclusion Criteria

Co-existing Condition:

Patients with a history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, or gastric ulceration are excluded.

Concurrent Medication:

Excluded:

• Systemic corticosteroids.
• Cytotoxic immunosuppressive agents.
• Radiotherapy.

Critically ill patients or those with CDC-defined AIDS are excluded.

Prior Medication:

Excluded within 1 month of study entry:

• Immunotherapy.

Patients with persistent generalized lymphadenopathy (PGL).