A Study of Nystatin in HIV-Infected Patients

Official Title: “Extended Maintenance Protocol for Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection (NOTE: Continuation Study Intended Only for Patients Who Have Completed FDA 103B)”

To evaluate the clinical toxicity, safety, and potential anti-HIV activity of intravenous nystatin in patients with HIV infection who have completed protocol FDA 103C. To evaluate the safety and potential antiviral activity of intravenous nystatin and oral didanosine (ddI) administered in an alternating regimen in this patient population.

Patients who have completed protocol FDA 103B are offered the option of receiving extended maintenance. Patients who have received no prior ddI are treated either with intravenous nystatin alone (at the same dose level administered in FDA 103B) or with a regimen of intravenous nystatin and ddI alternating on 3-week cycles. Treatment continues for 12 weeks.

Intervention(s) in this Clinical Trial

• Drug: Nystatin
• Drug: Didanosine

Inclusion Criteria

Patients must have:

• Completed 12 weeks of therapy with intravenous nystatin on protocol FDA 103B.
• No evidence of toxicity or progression of disease on protocol FDA 103B. (See protocol
• FDA 103B for initial entry requirements.)
• Active drug or alcohol abuse.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Argus Pharmaceuticals Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002313

Study ID Number: 103C

ClinicalTrials.gov Identifier: NCT00002313

Health Authority: United States: Food and Drug Administration