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NCT00002060 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002060
Other study ID # 008D
Secondary ID ISO-111-USA
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date June 1989
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Inosine pranobex

Locations
Country Name City State
United States Newport Pharmaceuticals International Inc Laguna Hills California

Sponsors (1)
Lead Sponsor Collaborator
Newport Pharmaceuticals International

Country where clinical trial is conducted

United States, 

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