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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
  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).
  • Platelet count.

Condition Intervention
Lymphatic Disease
HIV Infections
Drug: Inosine pranobex

Study Type: Interventional
Study Design: Masking: Double-Blind
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

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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

No publications provided

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
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Inosine Pranobex
AIDS-Related Complex

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lymphatic Diseases
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Inosine Pranobex
Adjuvants, Immunologic
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014