A Study of Isoprinosine in Patients With Severe AIDS

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.

Completed

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Key information

Conditions

HIV Infections AIDS-Related Complex Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Newport Pharmaceuticals International Inc

Laguna Hills, California, 92656, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inosine pranobex

Drug

Sponsors and collaborators

Lead sponsor

Newport Pharmaceuticals International

Industry

Registry information

Official study title

A Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Severe Acquired Immunodeficiency Syndrome

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed