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CompletedNCT00002060Updated Jun 24, 2005

A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)

An interventional study of Inosine pranobex in HIV Infections, sponsored by Newport Pharmaceuticals International. Completed at 1 site in United States. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Newport Pharmaceuticals International · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Ages
18 Years to 75 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • HIV Infections

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Keywords

  • AIDS-Related Opportunistic Infections
  • Inosine Pranobex
  • Homosexuality
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

Exclusion Criteria

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:

Excluded within 1 month of study entry:

  • Radiotherapy.

History of gout, uric acid urolithiasis, uric acid nephrolithiasis, or renal dysfunction.

  • Lymphoid malignancy.

Homosexual male patients with AIDS related complex (ARC).

Current IV drug abuse.

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Masking
Double

Interventions

  • DrugInosine pranobex
05

Study locations

1 site
  • Newport Pharmaceuticals International Inc
    Laguna Hills, California 92656, United States
06

Registry details

Key details

Study ID
NCT00002060
Lead sponsor
Newport Pharmaceuticals International
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 1989. You cannot join it, but the record below documents what was studied.

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