NCT00002297

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Newport Pharmaceuticals International · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphatic Disease
• HIV Infections

Interventions

Type	Name	Description
DRUG	Inosine pranobex

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

1 site across 1 country: United States