NCT00002296

Brief Summary

The objective of this Phase III, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of Isoprinosine in producing an immuno-restorative response within the study observation period (including the 2-month period following cessation of the 28 days of treatment), measured by one or more of the following immunological parameters:

  • Increase in natural killer (NK) cell activity.
  • Increase in total T-cells (OKT-11).
  • Increases in absolute number and percentage of T-helper cells (OKT-4).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 1989

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Lymphatic DiseaseHIV Infections

Keywords

T-LymphocytesImmune ToleranceInosine PranobexKiller CellsT-Lymphocytes, Helper-InducerAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Inosine pranobexDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following are excluded:
  • History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction and severe gastric ulcer.
  • Lymphoid malignancy.
  • Infectious mononucleosis caused by cytomegalovirus or Epstein-Barr virus.
  • Heart disease (especially if receiving cardiac glycosides).
  • Hemophilia.
  • Patients with the following are excluded:
  • Kaposi's sarcoma or overt opportunistic infections as follows:
  • Candida albicans, Pneumocystis carinii, Herpes simplex, Cryptococcus neoformans, Histoplasma capsulatum, Mycobacterium avium-intracellulare, Toxoplasma gondii, Legionella, Cryptosporidium, Isospora, and Papovavirus.
  • Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophil test (EBV) or cell culture (CMV).
  • History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer.
  • Critical illness.
  • Condition requiring hospitalization.
  • Women of childbearing age are excluded.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Newport Pharmaceuticals International Inc

Laguna Hills, California, 92656, United States

Location

MeSH Terms

Conditions

Lymphatic DiseasesHIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Inosine Pranobex

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesInosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1989-06

Locations

US(1)