The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002296
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 NCT00002296 on ClinicalTrials.gov Archive Site
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The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease
A Multi-Center Randomized Double-Blind Placebo-Controlled Study to Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy

The objective of this Phase III, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of Isoprinosine in producing an immuno-restorative response within the study observation period (including the 2-month period following cessation of the 28 days of treatment), measured by one or more of the following immunological parameters:

  • Increase in natural killer (NK) cell activity.
  • Increase in total T-cells (OKT-11).
  • Increases in absolute number and percentage of T-helper cells (OKT-4).
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Interventional
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Masking: Double-Blind
Primary Purpose: Treatment
  • Lymphatic Disease
  • 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:

  • History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction and severe gastric ulcer.
  • Lymphoid malignancy.
  • Infectious mononucleosis caused by cytomegalovirus or Epstein-Barr virus.
  • Heart disease (especially if receiving cardiac glycosides).
  • Hemophilia.

Patients with the following are excluded:

  • Kaposi's sarcoma or overt opportunistic infections as follows:
  • Candida albicans, Pneumocystis carinii, Herpes simplex, Cryptococcus neoformans, Histoplasma capsulatum, Mycobacterium avium-intracellulare, Toxoplasma gondii, Legionella, Cryptosporidium, Isospora, and Papovavirus.
  • Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophil test (EBV) or cell culture (CMV).
  • History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer.
  • Critical illness.
  • Condition requiring hospitalization.
  • Women of childbearing age are excluded.
  • Hemophilia.

Prior Medication:

Excluded:

  • Steroids.
  • Cytotoxic immunosuppressive agents.
  • Antiviral medicine.

Prior Treatment:

Excluded:

  • Radiotherapy.

Patients who have unexplained immunodepression and are at risk of developing AIDS.

  • Patients with prolonged generalized lymphadenopathy for 3 or more months (greater than 1 cm at two or more noncontiguous sites).

IV drug abuse.

Male
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002296
008C, ISO-106-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