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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002059

Run by

Newport Pharmaceuticals International

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Newport Pharmaceuticals International Inc — Laguna Hills, California, United States

Full record on ClinicalTrials.gov

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