A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)

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 is to determine the effect of Isoprinosine (inosine pranobex) in homosexual male patients with AIDS related complex (ARC) in delaying the onset of AIDS. Secondly, to determine the effect of Isoprinosine in decreasing the severity and/or incidence of lesser opportunistic infections and/or other conditions associated with ARC.

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

Concurrent Medication:

Excluded:

* Cardiac glycosides.

Patients with the following are excluded:

* AIDS.
* Presenting with chronic candida infection-colo/rectal, oral/pharyngeal, cutaneous (finger/toenails) - for = or \> 3 months who have not responded to therapy.
* Critical illness.
* Hemophilia.

Prior Medication:

Excluded within 1 month of study entry:

* Steroids.
* Cytotoxic immunosuppressive agents.
* Radiotherapy and/or systemic antiviral medication.
* Immunomodulators (including Isoprinosine).

Prior Treatment:

Excluded within 1 month of study entry:

* Radiotherapy.

History of gout, uric acid urolithiasis, uric acid nephrolithiasis, or renal dysfunction.

* Lymphoid malignancy.

Homosexual male patients with AIDS related complex (ARC).

Current IV drug abuse.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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-111-USA

Identifier Type: -

Identifier Source: secondary_id

008D