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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002059
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1989

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002059 on ClinicalTrials.gov Archive Site
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A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers
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.
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Interventional
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Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: Inosine pranobex
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002059
008E, ISO-133-USA
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Newport Pharmaceuticals International
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NIH AIDS Clinical Trials Information Service
June 1989

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP