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...
Date First Received: November 2, 1999
Last Updated: June 23, 2005
Verified by: NIH AIDS Clinical Trials Information Service, April 1994
Clinical Trial Phase: Phase 1 | Start Date:
Overall Status: Completed
Brief Summary
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)”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Dose Comparison, Safety Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Nystatin
- Drug: Didanosine
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: Argus Pharmaceuticals
Related Publications
References
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)
Additional Information
Information obtained from ClinicalTrials.gov on January 06, 2009
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
Clinical Trials Authorship and Review
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