Completed
Pharmacokinetics of Nystatin LF I.V. in ARC Patients
What is being tested
Nystatin
Drug
Who is being recruted
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+19 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorArgus Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This study focuses on understanding how the body processes a drug called Nystatin LF when given through an IV in individuals diagnosed with AIDS-related complex (ARC). The goal is to define the pharmacokinetic characteristics, which means how the drug moves through the body after a single dose at four different levels. The study is important as it could help improve treatment strategies for ARC patients, potentially leading to better management of the condition.
Principal SponsorArgus Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections
Criteria
5 inclusion criteria required to participate
CD4+ cell count between 100 and 300 cells/mm3
Diagnosis of AIDS-related complex (ARC)
Estimated life expectancy of at least 6 months
Normal neurological status
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14 exclusion criteria prevent from participating
Active alcohol or drug abuse unless they have been off drugs and/or alcohol for two weeks prior to start of study
Active opportunistic infection requiring ongoing therapy except patients being treated topically for oral thrush
All systemic medications within 72 hours of study entry
Biologic response modifier agents within 72 hours of study entry
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Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center