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

Sponsor
Newport Pharmaceuticals International (Industry)
Overall Status
Completed
CT.gov ID
NCT00002060
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Inosine pranobex
 N/A

Study Design

Study Type:
Interventional
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Newport Pharmaceuticals International Inc Laguna Hills California United States 92656

    Sponsors and Collaborators

    • Newport Pharmaceuticals International

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002060
    Other Study ID Numbers:
    • 008D
    • ISO-111-USA
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jun 1, 1989
    Keywords provided by , ,
    AIDS-Related Opportunistic Infections
    Inosine Pranobex
    Homosexuality
    Acquired Immunodeficiency Syndrome
    AIDS-Related Complex
    Additional relevant MeSH terms:
    AIDS-Related Complex
    Inosine Pranobex

    Study Results

    No Results Posted as of Jun 24, 2005