NCT00002060

Brief Summary

The objective is to determine the effect of Isoprinosine (inosine pranobex) in homosexual male patients with AIDS related complex (ARC) in delaying the onset of AIDS. Secondly, to determine the effect of Isoprinosine in decreasing the severity and/or incidence of lesser opportunistic infections and/or other conditions associated with ARC.

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

Click on a node to explore related trials.

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

AIDS-Related Opportunistic InfectionsInosine PranobexHomosexualityAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Inosine pranobexDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Concurrent Medication:
  • Excluded:
  • Cardiac glycosides.
  • Patients with the following are excluded:
  • AIDS.
  • Presenting with chronic candida infection-colo/rectal, oral/pharyngeal, cutaneous (finger/toenails) - for = or \> 3 months who have not responded to therapy.
  • Critical illness.
  • Hemophilia.
  • Prior Medication:
  • Excluded within 1 month of study entry:
  • Steroids.
  • Cytotoxic immunosuppressive agents.
  • Radiotherapy and/or systemic antiviral medication.
  • Immunomodulators (including Isoprinosine).
  • Prior Treatment:
  • +6 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 InfectionsAIDS-Related Opportunistic InfectionsHomosexualityAcquired 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 DiseasesOpportunistic InfectionsSexualitySexual BehaviorBehaviorSlow 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)