Completed
Intravenous and Oral Itraconazole Dosing in Advanced HIV Infection
What is being tested
Itraconazole
Drug
Who is being recruted
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorJanssen, LP
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients will receive intravenous itraconazole solution twice daily for 2 days and then once daily for five additional days. Patients then randomized to receive twice-daily or once-daily itraconazole oral solution for an additional 28 days.
Principal SponsorJanssen, LP
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.Design Details
36 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.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 SyndromeHIV Infections
Criteria
7 inclusion criteria required to participate
Antiretroviral therapy providing patient has already been on a stable, unchanged regimen for 8 weeks prior to study entry
CD4 lymphocyte count < 300 cells/mm3
Documented HIV infection
Negative urine screening
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9 exclusion criteria prevent from participating
Acute opportunistic infection or other significant concurrent illness that would preclude participation for the required 36 days
Change in antiretroviral therapy within 8 weeks prior to study entry
History of significant blood loss in the previous 30 days
History of surgical procedure that may interfere with absorption of itraconazole
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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
Erie County Med Ctr / Pharmacy D
Buffalo, United StatesOpen Erie County Med Ctr / Pharmacy D in Google MapsCompletedOne Study Center