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

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.

Completed

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Key information

Conditions

HIV Infections AIDS-Related Complex Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Neoplasms 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 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.

Treatment and study plan

Inosine pranobex

Drug

Sponsors and collaborators

Lead sponsor

Newport Pharmaceuticals International

Industry

Registry information

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