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



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

For Condition: HIV Infections
Status: Completed
Sponsor(s): Newport Pharmaceuticals International ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Male
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Newport Pharmaceuticals International Inc
Laguna Hills,  California,  92656
United States
 


Additional Information:
Study ID Numbers:
  008D;  ISO-111-USA
Study Start Date: 
Record last reviewed: June 1989
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002060

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3. A Study of AZT in HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma

4. Treatment of Abnormal Adipose Tissue Accumulation in HIV Patients

5. Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients

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