An Open-Label, Randomized Trial of Four Treatment Regimens for Patients With Disseminated Mycobacterium Avium Complex Disease and Acquired Immunodeficiency Syndrome (AIDS)
Ethambutol hydrochloride
+ Clarithromycin
+ Clofazimine
Infections transmises par le sang+20
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown. Patients are randomized to receive clarithromycin at one of two doses plus ethambutol and either rifabutin or clofazimine. Patients are followed at 1, 2, and 4 months and every 4 months thereafter for a minimum of 1.5 years to a common closing date.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.400 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 13 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria Concurrent Medication: Recommended in patients with CD4 count <= 200 cells/mm3: Antiretroviral therapy. PCP prophylaxis. Allowed in all patients: Isoniazid preventive therapy. Patients must have: HIV infection. Evidence of disseminated MAC infection. NOTE: Pregnant women are permitted to enroll following counseling by their clinician regarding the potential negative side effects of the study medications. These drugs should be used in pregnancy only when the potential benefits outweigh the risks. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known hypersensitivity to the study drugs. Other concurrent mycobacterial disease requiring therapy, i.e., disseminated nontuberculous mycobacterial infection or active tuberculosis. Concurrent Medication: Excluded: Additional medications with antimycobacterial activity (unless patient is failing or intolerant of assigned study regimen). Drugs with potential additive toxicity or with potential interaction with study drugs (e.g., fluconazole).
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 16 sites
Community Consortium of San Francisco
San Francisco, United StatesOuvrir Community Consortium of San Francisco dans Google MapsDenver CPCRA / Denver Public Hlth
Denver, United StatesVeterans Administration Med Ctr / Regional AIDS Program
Washington D.C., United StatesAIDS Research Consortium of Atlanta
Atlanta, United States