We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Isoprinosine in Patients With Severe AIDS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002295
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose

To evaluate the effect of Isoprinosine in patients diagnosed as having AIDS relative to:

Laboratory (immunologic defects):

  • Comparison of total helper and suppressor T-cell numbers among the groups.
  • Comparison of changes in natural killer cell activity.
  • Comparison of other laboratory findings among the groups.

Clinical changes:

  • Comparison of the frequency of opportunistic infections among the groups.
  • Comparison of the frequency of the development of AIDS-related malignancies.
  • Comparison of other clinical manifestations relative to severity and time of onset.

Condition Intervention
HIV Infections Drug: Inosine pranobex

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Severe Acquired Immunodeficiency Syndrome

Resource links provided by NLM:


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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Exclusion Criteria

Co-existing Condition:

Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer are excluded.

Concurrent Medication:

Excluded:

  • Steroids.
  • Cytotoxic immunosuppressive agents.
  • Radiotherapy.

The following are excluded:

  • Critically ill patients.
  • Patients receiving steroids, cytotoxic immunosuppressive agents, radiotherapy.
  • Patients who have received any other immunotherapy.
  • Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.

Prior Medication:

Excluded:

  • Any other immunotherapy.

Patients with severe AIDS and specified laboratory immunologic defects.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002295


Locations
United States, California
Newport Pharmaceuticals International Inc
Laguna Hills, California, United States, 92656
Sponsors and Collaborators
Newport Pharmaceuticals International
  More Information

ClinicalTrials.gov Identifier: NCT00002295     History of Changes
Other Study ID Numbers: 008F
ISO-141-USA
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: June 1989

Keywords provided by NIH AIDS Clinical Trials Information Service:
Infusions, Intravenous
Drug Evaluation
Administration, Oral
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Biological Availability

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