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Completed

NCT Number: NCT00002061

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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Key information

Conditions

Lymphatic Disease AIDS-Related Complex Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lymphatic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Newport Pharmaceuticals International Inc

Laguna Hills, California, 92656, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inosine pranobex

Drug

Sponsors and collaborators

Lead sponsor

Newport Pharmaceuticals International

Industry

Registry information

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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