Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC) - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001998 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
Official Title ^ICMJE	Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
Brief Summary	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.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Dose Comparison, Pharmacokinetics Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Nystatin
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria Patients must have the following: Positive HIV antibody test. Diagnosis of AIDS-related complex (ARC). CD4+ cell count between 100 and 300 cells/mm3. Estimated life expectancy of at least 6 months. Normal neurological status. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Active opportunistic infection requiring ongoing therapy except patients being treated topically for oral thrush. Patients with the following are excluded: Active opportunistic infection. Known hypersensitivity to polyene antibiotics. Unwillingness to sign an informed consent or to be in compliance of protocol requirements. Prior Medication: Excluded within 72 hours of study entry: Biologic response modifier agents. Corticosteroids. Cytotoxic chemotherapeutic agents. Potential nephrotoxins. Potential neutropenic agents. Rifampin or rifampin derivatives. Systemic anti-infectives. Phenytoin or barbiturates (inducers of microsomal enzymes). All systemic medications. Prior Treatment: Excluded within 72 hours prior to study entry: Radiation therapy. Active alcohol or drug abuse unless they have been off drugs and/or alcohol for two weeks prior to start of study.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001998
Responsible Party
Study ID Numbers ^ICMJE	103A, AR-90-01-002
Study Sponsor ^ICMJE	Argus Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	November 1992
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP