Completed

Isoprinosine's Immuno-Restorative Effect in Immunodepressed Patients with Uncomplicated Generalized Lymphadenopathy

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What is being tested

Inosine pranobex

Drug
Who is being recruted

Blood-Borne Infections+16

+ Urogenital Diseases

+ Genital Diseases

From 18 to 50 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorNewport Pharmaceuticals International
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on immunodepressed patients, or individuals with a weakened immune system, who have uncomplicated generalized lymphadenopathy, a condition characterized by the enlargement of lymph nodes. The main goal is to investigate the effect of a drug called Isoprinosine in improving the immune response of these patients. The significance of this research lies in its potential to find a treatment that can restore the immune system's function in immunodepressed patients, thereby addressing an unmet need in their care. During this study, participants are randomly assigned to receive either Isoprinosine or a placebo, a substance that has no therapeutic effect, for a period of 28 days. The study continues to observe the participants for an additional 2 months after the treatment ends. The effect of Isoprinosine is measured by changes in certain immune system parameters, such as an increase in the activity of natural killer (NK) cells, total T-cells, and T-helper cells. These cells play crucial roles in defending the body against infections and diseases.

NCT00002061
Principal SponsorNewport Pharmaceuticals International
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesHemic and Lymphatic DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexLymphatic DiseasesHIV Infections

Criteria

17 exclusion criteria prevent from participating
Radiotherapy.

Steroids, cytotoxic immunosuppressive agents.

Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophile test (EBV) or cell culture (CMV).

Condition requiring hospitalization.

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Newport Pharmaceuticals International Inc

Laguna Hills, United StatesOpen Newport Pharmaceuticals International Inc in Google Maps
CompletedOne Study Center