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

Completed · Not applicable

Conditions studied: Lymphatic Disease, HIV Infections

In brief

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).

Key facts

Study ID

NCT00002061

Run by

Newport Pharmaceuticals International

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• 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).

Where it is running

• Newport Pharmaceuticals International Inc — Laguna Hills, California, United States

Full record on ClinicalTrials.gov

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