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Sponsored by: |
Argus Pharmaceuticals |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002097 |
To evaluate the clinical toxicity, safety, and maximum tolerated dose (MTD) of intravenous nystatin in patients with HIV infection. To evaluate the potential anti-HIV activity and clinical pharmacology of intravenous nystatin.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Nystatin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Dose Comparison, Pharmacokinetics Study |
Official Title: | A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded within 2 weeks prior to study entry:
Prior Treatment:
Excluded within 2 weeks prior to study entry:
Study ID Numbers: | 103B, AR-91-35,606-004 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002097 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Nystatin Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Virus Diseases Anti-Bacterial Agents Anti-Infective Agents Sexually Transmitted Diseases, Viral HIV Infections Antifungal Agents |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Nystatin AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Nystatin Infection Pharmacologic Actions |
Immunologic Deficiency Syndromes Membrane Transport Modulators Virus Diseases Anti-Bacterial Agents HIV Infections Therapeutic Uses Antifungal Agents Sexually Transmitted Diseases Lentivirus Infections Ionophores Retroviridae Infections |