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A Study of Nystatin in HIV-Infected Patients - Article


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Nystatin Troche

Mycostatin Pastilles 




Clinical Trial: A Study of Nystatin in HIV-Infected Patients

This study has been completed.

Sponsored by: Argus Pharmaceuticals
Information provided by: AIDS Clinical Trials Information Service

Purpose

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.

Condition Treatment or Intervention Phase
HIV Infections
 Drug: Nystatin
 Drug: Didanosine
Phase I

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Dose Comparison, Safety Study

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)

Further Study Details: 

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients must have:

Active drug or alcohol abuse.


Location Information


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

More Information

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)

Study ID Numbers:  103C; AR-91-35,606-005A
Record last reviewed:  April 1994
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002313
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: June 1, 2005
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