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

Newport Pharmaceuticals

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Inosine pranobex

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002060

008D

ISO-111-USA

Details and patient eligibility

About

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.

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.