A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)
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ClinicalTrials.gov Identifier: NCT00002060 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Inosine pranobex | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC) |


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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002060
United States, California | |
Newport Pharmaceuticals International Inc | |
Laguna Hills, California, United States, 92656 |
ClinicalTrials.gov Identifier: | NCT00002060 History of Changes |
Other Study ID Numbers: |
008D ISO-111-USA |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | June 1989 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections Inosine Pranobex Homosexuality Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Additional relevant MeSH terms:
HIV Infections AIDS-Related Complex Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Inosine Pranobex Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antiviral Agents Anti-Infective Agents |