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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
History of Changes
  Purpose

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).

Condition Intervention
Lymphatic Disease
HIV Infections
 Drug: Inosine pranobex

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multi-Center Randomized Double-Blind Placebo-Controlled Study to Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002296

Locations
United States, California
Newport Pharmaceuticals International Inc
Laguna Hills, California, United States, 92656
Sponsors and Collaborators
Newport Pharmaceuticals International
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002296     History of Changes
Other Study ID Numbers: 008C, ISO-106-USA
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
T-Lymphocytes
Immune Tolerance
Inosine Pranobex
Killer Cells
 T-Lymphocytes, Helper-Inducer
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lymphatic Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Slow Virus Diseases
Inosine Pranobex
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013