A Study of Isoprinosine in Patients With Lymph Node Disease

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.

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Key information

Conditions

Lymphatic Disease AIDS-Related Complex Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lymphatic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Newport Pharmaceuticals International Inc

Laguna Hills, California, 92656, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Inosine pranobex

Drug

Sponsors and collaborators

Lead sponsor

Newport Pharmaceuticals International

Industry

Registry information

Official study title

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

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed