A Study of Isoprinosine in Patients With Lymph Node Disease - Full Text View

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

Study ID Numbers:	008A, ISO-103-USA
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002297
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:

Virus Diseases

Lymphatic Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

AIDS-Related Complex

Inosine Pranobex

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Slow Virus Diseases

Immunologic Factors

Immune System Diseases

Therapeutic Uses

Physiological Effects of Drugs

Adjuvants, Immunologic

Lentivirus Infections

Infection

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008

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