Completed
Azithromycin Prophylaxis Against Mycobacterium Avium Complex Disease in HIV-Infected Patients with Low CD4 Count
What is being tested
Azithromycin
Drug
Who is being recruted
Blood-Borne Infections+21
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+15 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This study focuses on HIV-infected individuals who have weakened immune systems, specifically those with a CD4 count below 100 cells/mm3. The main goal is to evaluate the effectiveness and safety of a drug called azithromycin in preventing the spread of Mycobacterium avium complex (MAC), a common infection in HIV patients. The study aims to provide a solution for reducing the risk of MAC in this population, potentially improving their quality of life and addressing a significant challenge in HIV care.
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.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 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 SyndromeAIDS-Related ComplexMycobacterium avium-intracellulare InfectionHIV Infections
Criteria
6 inclusion criteria required to participate
Anti-pneumocystis prophylactic therapy (dihydropteroate synthetase inhibitors with or without dihydrofolate reductase inhibitors, pentamidine)
CD4 count < 100 cells/mm3
Concomitant anti-HIV therapy (AZT, ddI, ddC) or antifungal therapy (including azoles)
HIV infection
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9 exclusion criteria prevent from participating
Any other acute clinical condition likely to interfere with completion of the protocol
Any putative anti-MAC therapies including rifampin, rifabutin, clofazimine, ethambutol, cycloserine, ethionamide, amikacin, and ciprofloxacin or other quinolones thought to be active against MAC within the past 4 weeks
Chest x-ray suggestive of any active disease, in particular tuberculosis
Concomitant putative immunostimulants
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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 3 locations
Womack Army Med Ctr / Med Clinic
Fort Bragg, United StatesUnited States Air Force Med Ctr
Lackland Air Force Base, United StatesCompleted3 Study Centers