Completed
Azithromycin, Rifabutin, and Fluconazole for MAC and Fungal Infections Prevention in HIV-Infected Patients
What is being tested
Azithromycin
+ Rifabutin
+ Fluconazole
Drug
Who is being recruted
Blood-Borne Infections+21
+ Urogenital Diseases
+ Genital Diseases
Over 12 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Summary
Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients are randomized to receive azithromycin alone, rifabutin alone, or the two drugs in combination for MAC prophylaxis. Patients in each treatment group further receive one of two doses of concomitant fluconazole for deep fungal prophylaxis, unless specifically excluded for fluconazole randomization. Patients are followed for 1 to 2 years.
Principal SponsorPfizer
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
720 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 12 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 DiseasesActinomycetales InfectionsBacterial Infections and MycosesBacterial InfectionsCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMycobacterium InfectionsMycobacterium Infections, NontuberculousRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsGram-Positive Bacterial InfectionsAcquired Immunodeficiency SyndromeMycosesMycobacterium avium-intracellulare InfectionHIV Infections
Criteria
8 inclusion criteria required to participate
HIV infection or history of an AIDS-defining condition by CDC criteria.
Maintenance therapy for CMV retinitis.
One documented CD4 count < 100 cells/mm3 within 12 months prior to study entry.
NO acute opportunistic infection.
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8 exclusion criteria prevent from participating
Active fungal infection (cryptococcosis, histoplasmosis, blastomycosis, aspergillosis, Candida esophagitis, thrush, vaginal candidiasis).
Positive baseline urine cryptococcal culture.
Maintenance therapy for deep fungal infections.
Chronic therapy with ketoconazole or fluconazole.
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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 12 locations
Los Angeles County - USC Med Ctr
Los Angeles, United StatesOpen Los Angeles County - USC Med Ctr in Google MapsUCI Med Ctr
Orange, United StatesUCSD Treatment Ctr / Dept of Medicine and Pediatrics
San Diego, United StatesSanta Clara Valley Med Ctr
San Jose, United StatesCompleted12 Study Centers