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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002059
• Other study ID #: 008E
• Secondary ID: ISO-133-USA
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1989
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Inosine pranobex

Locations

Country	Name	City	State
United States	Newport Pharmaceuticals International Inc	Laguna Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Newport Pharmaceuticals International

Country where clinical trial is conducted

United States,