A Study of Nystatin in HIV-Infected Patients
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Treatment, Dose Comparison, Safety Study
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
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