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A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy

This study has been completed.

Sponsored by: Newport Pharmaceuticals International
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002061
  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 immunologic parameters:

  • Increase in natural killer (NK) cell activity.
  • Increase in total T-cells (OKT-11).
  • Increases in absolute number and percentages of T-helper cells (OKT-4).

Condition Intervention
Lymphatic Disease
HIV Infections
Drug: Inosine pranobex

MedlinePlus related topics:   AIDS    Lymphatic Diseases   

Drug Information available for:   Inosine    Inosine pranobex   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind
Official Title:   A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
  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 (CMV) or Epstein-Barr virus (EBV).
  • Heart disease (especially if receiving cardiac glycosides).
  • Hemophilia.

Patients with the following are excluded:

  • Kaposi's sarcoma or overt opportunistic infections.
  • Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophile test (EBV) or cell culture (CMV).
  • A 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.

Prior Medication:

Excluded:

  • Steroids, cytotoxic immunosuppressive agents.
  • Antiviral medicine.
  • Excluded within 1 month of study entry:
  • Immunomodulators (including Isoprinosine).

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: NCT00002061

Locations
United States, California
Newport Pharmaceuticals International Inc    
      Laguna Hills, California, United States, 92656

Sponsors and Collaborators
Newport Pharmaceuticals International
  More Information


Study ID Numbers:   008B, ISO-105-USA
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002061
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

Study placed in the following topic categories:
Virus Diseases
Lymphatic Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Inosine Pranobex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immunologic Factors
Immune System Diseases
Therapeutic Uses
Physiological Effects of Drugs
Adjuvants, Immunologic
Lentivirus Infections
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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