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

This study has been completed.

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

Sponsor:	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

Study Type:	Interventional
Study Design:	Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Inosine Inosine pranobex

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00002059 History of Changes
Other Study ID Numbers:	008E, ISO-133-USA
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
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

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

Slow Virus Diseases
Inosine Pranobex
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012