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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002061
• Other study ID #: 008B
• Secondary ID: ISO-105-USA
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1989
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Lymphatic Disease
• Lymphatic Diseases

Intervention

Drug:
• Inosine pranobex

Locations

Country	Name	City	State
United States	Newport Pharmaceuticals International Inc	Laguna Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Newport Pharmaceuticals International

Country where clinical trial is conducted

United States,