A Study of Isoprinosine in Patients With Lymph Node Disease

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Newport Pharmaceuticals International
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002297

Purpose

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.

Condition	Intervention
Lymphatic Disease HIV Infections	Drug: Inosine pranobex

MedlinePlus related topics: AIDS Lymphatic Diseases

Drug Information available for: Inosine Inosine pranobex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind
Official Title:	A Multi-Center Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Unexplained Generalized Lymphadenopathy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002297

Locations

United States, California
Newport Pharmaceuticals International Inc
Laguna Hills, California, United States, 92656

Sponsors and Collaborators

Newport Pharmaceuticals International

More Information

No publications provided

Study ID Numbers:	008A, ISO-103-USA
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002297 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Inosine Pranobex
AIDS-Related Complex

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Immunologic Factors
Acquired Immunodeficiency Syndrome
Adjuvants, Immunologic
AIDS-Related Complex
Inosine Pranobex
Antiviral Agents

Immunologic Deficiency Syndromes
Virus Diseases
Lymphatic Diseases
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Acquired Immunodeficiency Syndrome
Adjuvants, Immunologic
Inosine Pranobex
Infection

Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Lymphatic Diseases
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009