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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002061
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 NCT00002061 on ClinicalTrials.gov Archive Site
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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
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 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).
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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 (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.

Male
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002061
008B, ISO-105-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