Nystatin Troche |
Mycostatin Pastilles |
Clinical Trial: A Study of Nystatin in HIV-Infected Patients
This study has been completed.
|
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)
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:
- 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.
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)
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
Resources
- Mycostatin Pastilles (Drug Digest)
- Nystatin Troche (Drug Digest)

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