A Study of Isoprinosine in Patients With Lymph Node Disease

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002297
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1989

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002297 on ClinicalTrials.gov Archive Site
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A Study of Isoprinosine in Patients With Lymph Node Disease
A Multi-Center Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Unexplained Generalized Lymphadenopathy

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.
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Interventional
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Masking: Double-Blind
Primary Purpose: Treatment
  • Lymphatic Disease
  • HIV Infections
Drug: Inosine pranobex
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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).

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002297
008A, ISO-103-USA
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Newport Pharmaceuticals International
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NIH AIDS Clinical Trials Information Service
June 1989

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP