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

N/ACompletedNCT00002060

Newport Pharmaceuticals International

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

DOUBLE

Conditions

HIV Infections

Interventions

Inosine pranobexDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Newport Pharmaceuticals International Inc

Laguna Hills, California, United States

Data from ClinicalTrials.gov

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