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.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	Newport Pharmaceuticals International
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002061

Purpose

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).

Condition	Intervention
Lymphatic Disease HIV Infections	Drug: Inosine pranobex

Study Type:	Interventional
Study Design:	Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Lymphatic Diseases

Drug Information available for: Inosine Inosine pranobex

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002061

Locations

United States, California
Newport Pharmaceuticals International Inc
Laguna Hills, California, United States, 92656

Sponsors and Collaborators

Newport Pharmaceuticals International

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002061 History of Changes
Other Study ID Numbers:	008B, ISO-105-USA
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

T-Lymphocytes
Immune Tolerance
Inosine Pranobex
Killer Cells

T-Lymphocytes, Helper-Inducer
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lymphatic Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes

Immune System Diseases
Slow Virus Diseases
Inosine Pranobex
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012