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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Newport Pharmaceuticals International
• Treatments: Inosine Pranobex

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.