Completed
Extended Maintenance with Intravenous Nystatin for HIV-Positive Patients
What is being tested
Nystatin
+ Didanosine
Drug
Who is being recruted
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+3 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Summary
Principal SponsorArgus Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
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.
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
2 inclusion criteria required to participate
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.)
1 exclusion criteria prevent from participating
Active drug or alcohol abuse
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