A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers

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 double-blind placebo-controlled study is to evaluate the effect of Isoprinosine in a group of homogenous male volunteers who present with immunologic defects relative to:

* Comparison of total helper and suppressor T-cell number between the groups.
* Comparison of the phytohemagglutinins (PHA) and concanavalin A lymphoproliferative response and natural killer (NK) cell activity between the groups.
* Determination of the clinical course of the volunteers after discontinuance of Isoprinosine.

Detailed Description

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Conditions

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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:

* Opportunistic infections or Kaposi's sarcoma.
* Critical illness.
* History of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.

Concurrent Medication:

Excluded:

* Steroids.
* Cytotoxic immunosuppressive agents.

Concurrent Treatment:

Excluded:

* Radiotherapy.

The following are excluded:

* Opportunistic infections or Kaposi's sarcoma.
* Critically ill patients.
* Patients receiving steroids, cytotoxic immunosuppressive agents, and/or radiotherapy.
* Patients who have received any other immunotherapy.
* Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.

Prior Medication:

Excluded:

* Any other immunotherapy.

Patients who fall into the group which is at risk of developing cutaneous sarcoma and/or opportunistic diseases but at present have no signs or symptoms of these diseases.

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-133-USA

Identifier Type: -

Identifier Source: secondary_id

008E