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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Newport Pharmaceuticals International
• Treatments: Inosine Pranobex

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.