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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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).

Detailed Description

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Conditions

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Lymphatic Disease HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Inosine pranobex

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Locations

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Newport Pharmaceuticals International Inc

Laguna Hills, California, United States

Site Status

Countries

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United States

Other Identifiers

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ISO-105-USA

Identifier Type: -

Identifier Source: secondary_id

008B