A Study of Isoprinosine in Patients With Severe AIDS

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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To evaluate the effect of Isoprinosine in patients diagnosed as having AIDS relative to:

Laboratory (immunologic defects):

* Comparison of total helper and suppressor T-cell numbers among the groups.
* Comparison of changes in natural killer cell activity.
* Comparison of other laboratory findings among the groups.

Clinical changes:

* Comparison of the frequency of opportunistic infections among the groups.
* Comparison of the frequency of the development of AIDS-related malignancies.
* Comparison of other clinical manifestations relative to severity and time of onset.

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 a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer are excluded.

Concurrent Medication:

Excluded:

* Steroids.
* Cytotoxic immunosuppressive agents.
* Radiotherapy.

The following are excluded:

* Critically ill patients.
* Patients receiving steroids, cytotoxic immunosuppressive agents, 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 with severe AIDS and specified laboratory immunologic defects.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

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-141-USA

Identifier Type: -

Identifier Source: secondary_id

008F