NCT00002059

Brief Summary

The objective of this double-blind placebo-controlled study is to evaluate the effect of Isoprinosine in a group of homogenous male volunteers who present with immunologic defects relative to:

  • Comparison of total helper and suppressor T-cell number between the groups.
  • Comparison of the phytohemagglutinins (PHA) and concanavalin A lymphoproliferative response and natural killer (NK) cell activity between the groups.
  • Determination of the clinical course of the volunteers after discontinuance of Isoprinosine.

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

HIV Infections

Keywords

T-Lymphocytes, Suppressor-EffectorNeoplasmsInosine PranobexKiller CellsT-Lymphocytes, Helper-InducerAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Inosine pranobexDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following are excluded:
  • Opportunistic infections or Kaposi's sarcoma.
  • Critical illness.
  • History of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.
  • Concurrent Medication:
  • Excluded:
  • Steroids.
  • Cytotoxic immunosuppressive agents.
  • Concurrent Treatment:
  • Excluded:
  • Radiotherapy.
  • The following are excluded:
  • Opportunistic infections or Kaposi's sarcoma.
  • Critically ill patients.
  • +7 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

HIV InfectionsNeoplasmsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Inosine Pranobex

Condition Hierarchy (Ancestors)

Blood-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)