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A Study of Nystatin in HIV-Infected Patients

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Nystatin (Drug); Didanosine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Argus Pharmaceuticals

Summary

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.

Clinical Details

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)

Study design: Endpoint Classification: Safety Study, Primary Purpose: Treatment

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Twelve Oaks Hosp, Houston, Texas 77027, United States
Additional Information

Related publications:

Rios A, Brewton G, Crofoot G, Quesada J, Lenk R, Lopez-Berenstein G. A phase I-II clinical study of Nystatin-LF IV in patients with HIV infections. Int Conf AIDS. 1993 Jun 6-11;9(1):483 (abstract no PO-B26-2089)


Last updated: June 23, 2005

Page last updated: August 23, 2015

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