A Study of Nystatin in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002313
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1994

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002313 on ClinicalTrials.gov Archive Site
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A Study of Nystatin in HIV-Infected Patients
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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Nystatin
  • Drug: Didanosine
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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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002313
103C, AR-91-35,606-005A
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Argus Pharmaceuticals
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NIH AIDS Clinical Trials Information Service
April 1994

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP