A Study of Isoprinosine in Patients With Lymph Node Disease

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Newport Pharmaceuticals International
• Treatments: Inosine Pranobex

Criteria

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).