A Study of Isoprinosine in Patients With Lymph Node Disease

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 objectives of this study are to determine the effects of isoprinosine in patients diagnosed as having unexplained generalized lymphadenopathy. Variables to be examined will include:

Signs and symptoms:

* Lymphadenopathy.
* Fever.
* Weight loss.
* Occurrence of opportunistic infections.

Cell-mediated immune system parameters:

* T-helper cell (OKT4) numbers and proportions.
* T-suppressor cell (OKT8) numbers and proportions.
* Natural killer (NK) cell activity.
* Lymphocyte blastogenic response to phytohemagglutinin (PHA).
* Lymphocyte blastogenic response to pokeweed mitogen (PWM).
* Immunoglobulin (IgG, IgA, IgM, IgE, IgD) profile.
* Circulating immune complexes. Infections characteristically associated with AIDS, such as Candida albicans, Pneumocystis carinii pneumonia, Cytomegalovirus, Herpes simplex, Cryptococcus, Histoplasma, Toxoplasma, Cryptosporidium, Mycobacterium avium- intracellulare, Legionella, and Isospora.

Safety parameters:

* Blood chemistry including serum uric acid (PurposeA-12).
* Complete blood count (CBC).
* Platelet count.

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 a history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, or gastric ulceration are excluded.

Concurrent Medication:

Excluded:

* Systemic corticosteroids.
* Cytotoxic immunosuppressive agents.
* Radiotherapy.

Critically ill patients or those with CDC-defined AIDS are excluded.

Prior Medication:

Excluded within 1 month of study entry:

* Immunotherapy.

Patients with persistent generalized lymphadenopathy (PGL).

Minimum Eligible Age

18 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-103-USA

Identifier Type: -

Identifier Source: secondary_id

008A