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A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection. Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection. conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection. Clinical research trials and A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection. health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.. A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection. Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection. clinical trial. Subjects frequently get the best healthcare possible for their A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection. condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.

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A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.



A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.

For Condition: HIV Infections
Status: Completed
Sponsor(s): Argus Pharmaceuticals ,
Synopsis: 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.
Details: Cohorts of three patients each are treated at escalating doses of intravenous nystatin, administered every other day, until the MTD is reached. Each cohort is observed for toxicity for at least 2 weeks before escalation in subsequent patient cohorts is initiated.
Eligibility:
Study Type:  Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - Aerosolized pentamidine (300 mg once a month) for PCP prophylaxis in patients with CD4 count <= 200 cells/mm3. (Patients with CD4 count > 200 cells/mm3 who are already on aerosolized pentamidine may continue such therapy at the discretion of the investigator.) Allowed: - Prophylaxis against Mycobacterium avium Complex in patients with CD4 count <= 100 cells/mm3. Concurrent Treatment: Allowed: - Local treatment for Kaposi's sarcoma lesions with less than 25 percent increase in measurable disease. Patients must have: - HIV antibody positivity. - Absolute CD4 count < 500 cells/mm3 on two determinations within 15 days prior to study entry. - At least 6 months of prior zidovudine (AZT) therapy. - No active opportunistic infection requiring ongoing therapy. - Normal neurologic status by standard assessment. - Life expectancy of at least 6 months. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Neoplasm other than basal cell carcinoma of the skin or stable untreated HIV-related Kaposi's sarcoma (provided there is no progression in the Kaposi's sarcoma beyond 25 percent of measurable disease). - Clinically significant cardiac disease. - Known hypersensitivity to polyene antibiotics. Patients with the following prior conditions are excluded: - History of myocardial infarction or arrhythmias. Prior Medication: Excluded within 2 weeks prior to study entry: - Antiretroviral agents or interferons. - Biological response modifiers. - Corticosteroids. - Cytotoxic chemotherapeutic agents. - Drugs that can cause neutropenia or significant nephrotoxicity. - Rifampin or rifampin derivatives. - Systemic anti-infectives. Prior Treatment: Excluded within 2 weeks prior to study entry: - Radiation therapy. Active drug or alcohol abuse.
Total Enrollment: 

Location and Contact Information:

Twelve Oaks Hosp
Houston,  Texas,  77027
United States
 


Additional Information:
Study ID Numbers:  103B;  AR-91-35,606-004
Study Start Date: 
Record last reviewed: April 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002097

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3. Effects of Storage on Lactate in Blood Samples

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A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.
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