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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002060

Run by

Newport Pharmaceuticals International

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

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:
• 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.

Where it is running

• Newport Pharmaceuticals International Inc — Laguna Hills, California, United States

Full record on ClinicalTrials.gov

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