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A Study of Isoprinosine in Patients With Lymph Node Disease

Sponsor
Newport Pharmaceuticals International (Industry)
Overall Status
Completed
CT.gov ID
NCT00002297
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

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.

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 Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Unexplained Generalized Lymphadenopathy

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 0 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

    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).

    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:
    NCT00002297
    Other Study ID Numbers:
    • 008A
    • ISO-103-USA
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jun 1, 1989
    Keywords provided by , ,
    Inosine Pranobex
    AIDS-Related Complex
    Additional relevant MeSH terms:
    Lymphatic Diseases
    Inosine Pranobex

    Study Results

    No Results Posted as of Jun 24, 2005