A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Impact of Nystatin on the Development of Oral Irritation in Patients Receiving High Dose Intravenous Interleukin-2
Completed
National Cancer Institute (NCI)
Phase 3
1999-04-01
In patients who are receiving intravenous high dose Interleukin-2, patients will be
randomized into two groups: group one will receive nystatin swish and swallow immediately
before initiation of IL-2, and the second group will receive a placebo. The patients in each
group will be monitored and evaluated for differences in the rate and severity of development
of oral irritation during treatment. They will also be studied for differences between the
two groups in the number of doses of IL-2 taken.
Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
Completed
Argus Pharmaceuticals
N/A
1969-12-31
To define the pharmacokinetic characteristics of Nystatin LF IV (intravenous) in human
subjects with AIDS-related complex (ARC) after administration of a single IV dose at each of
4 dose levels.
Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
Completed
Bristol-Myers Squibb
N/A
1969-12-31
To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the
prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (group III
or IV, CDC classification).
A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.
Completed
Argus Pharmaceuticals
Phase 1
1969-12-31
To evaluate the clinical toxicity, safety, and maximum tolerated dose (MTD) of intravenous
nystatin in patients with HIV infection. To evaluate the potential anti-HIV activity and
clinical pharmacology of intravenous nystatin.
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