Completed

Itraconazole's Safety and Efficacy in Preventing Histoplasmosis and Other Fungal Infections in HIV-infected Patients

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What is being tested

Itraconazole

Drug
Who is being recruted

Blood-Borne Infections+16

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorJanssen, LP
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on HIV-infected individuals with low CD4 counts (less than 150 cells/mm3) who live in areas where histoplasmosis, a fungal infection, is common. The main goal is to evaluate if a medication called itraconazole can safely and effectively prevent histoplasmosis in these patients, compared to a placebo. The study also aims to see if itraconazole can prevent other harmful fungal infections, such as cryptococcosis, aspergillosis, and certain types of candidiasis. During the study, participants receive either itraconazole or a placebo. The study measures the safety and effectiveness of itraconazole by monitoring how many participants develop histoplasmosis or other fungal infections. It also keeps track of any side effects to assess the safety of the medication.

NCT00002438
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.

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 13 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 DiseasesBacterial Infections and MycosesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMycosesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeHistoplasmosisHIV Infections

Criteria

6 inclusion criteria required to participate
Absolute CD4 count < 150 cells/mm3
HIV infection
Life expectancy of at least 1 year
No current or past active histoplasmosis
Show More Criteria
15 exclusion criteria prevent from participating
Astemizole
Carbamazepine
Continual antacids
H2 blockers
Show More Criteria

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 7 locations

Infectious Diseases Research Clinic / Indiana Univ Hosp

Indianapolis, United StatesOpen Infectious Diseases Research Clinic / Indiana Univ Hosp in Google Maps

Infectious Diseases of Indianapolis

Indianapolis, United States

Univ of Missouri at Kansas City School of Medicine

Kansas City, United States

Infectious Diseases Association / Research Med Ctr

Kansas City, United States
Completed7 Study Centers