A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers - Full Text View

A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers

This study has been completed.

Sponsored by:	Newport Pharmaceuticals International
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002059

Purpose

The objective of this double-blind placebo-controlled study is to evaluate the effect of Isoprinosine in a group of homogenous male volunteers who present with immunologic defects relative to:

Comparison of total helper and suppressor T-cell number between the groups.
Comparison of the phytohemagglutinins (PHA) and concanavalin A lymphoproliferative response and natural killer (NK) cell activity between the groups.
Determination of the clinical course of the volunteers after discontinuance of Isoprinosine.

Condition	Intervention
HIV Infections	Drug: Inosine pranobex

MedlinePlus related topics:

AIDS

Drug Information available for:

Inosine Inosine pranobex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind

Official Title:	A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers

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 the following are excluded:

Opportunistic infections or Kaposi's sarcoma.
Critical illness.
History of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.

Concurrent Medication:

Excluded:

Steroids.
Cytotoxic immunosuppressive agents.

Concurrent Treatment:

Excluded:

Radiotherapy.

The following are excluded:

Opportunistic infections or Kaposi's sarcoma.
Critically ill patients.
Patients receiving steroids, cytotoxic immunosuppressive agents, and/or radiotherapy.
Patients who have received any other immunotherapy.
Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.

Prior Medication:

Excluded:

Any other immunotherapy.

Patients who fall into the group which is at risk of developing cutaneous sarcoma and/or opportunistic diseases but at present have no signs or symptoms of these diseases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002059

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:	008E, ISO-133-USA
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002059
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

T-Lymphocytes, Suppressor-Effector

Neoplasms

Inosine Pranobex

Killer Cells

T-Lymphocytes, Helper-Inducer

Acquired Immunodeficiency Syndrome

AIDS-Related Complex

Study placed in the following topic categories:

Virus 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