Completed

Isoprinosine Impact on Unexplained Generalized Lymphadenopathy

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What is being tested

Inosine pranobex

Drug
Who is being recruted

Blood-Borne Infections+15

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+7 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 understanding the effects of a drug called Isoprinosine (Inosiplex) in patients with unexplained generalized lymphadenopathy, a condition characterized by swelling of lymph nodes throughout the body. The study aims to address the challenges faced in managing this condition and potentially improve the care provided to these patients. It's important because it could help uncover new ways to treat unexplained generalized lymphadenopathy and related symptoms. During the study, participants will receive either Isoprinosine or a placebo, a substance that looks like the drug but contains no active ingredients. The effects of the drug will be measured by examining various health aspects. These include signs and symptoms like lymph node swelling, fever, weight loss, and occurrence of opportunistic infections. The study will also evaluate certain parameters of the cell-mediated immune system, such as T-helper and T-suppressor cell numbers, Natural Killer (NK) cell activity, and responses to specific substances. Safety measures like blood chemistry and complete blood count will be monitored to ensure the wellbeing of the participants.

NCT00002297
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.

Over 18 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 InfectionsAIDS-Related ComplexLymphatic DiseasesHIV Infections

Criteria

7 exclusion criteria prevent from participating
Critically ill patients or those with CDC-defined AIDS are excluded

Cytotoxic immunosuppressive agents are excluded

Immunotherapy within 1 month of study entry is excluded

Patients with a history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, or gastric ulceration are excluded

Show More Criteria

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