Clinical Trials

MainTitle

A Study of Isoprinosine in Patients With Lymph Node Disease

This study has been completed
Sponsor
Newport Pharmaceuticals International


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002297

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: June 1989
History of Changes
Purpose

Purpose

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).
let count.

Condition Intervention
Lymphatic Disease
HIV Infections

Drug : Inosine pranobex

Study Type: Interventional
Study Design: 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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002297

Locations

United States, California
Newport Pharmaceuticals International Inc
Laguna Hills, California, United States, 92656

Sponsors and Collaborators

Newport Pharmaceuticals International
More Information

More Information


Responsible Party: Newport Pharmaceuticals International  
ClinicalTrials.gov Identifier: NCT00002297   History of Changes  
Other Study ID Numbers: 008A  
  ISO-103-USA  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Inosine Pranobex
AIDS-Related Complex

Additional relevant MeSH terms:
HIV Infections
Lymphatic Diseases
Inosine Pranobex

ClinicalTrials.gov processed this data on December 14, 2017
This information is provided by ClinicalTrials.gov.