A Prospective, Randomized, Comparative Study of the Safety and Efficacy of Clarithromycin Versus Rifabutin Versus the Combination of Clarithromycin Plus Rifabutin for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia or Disseminated MAC Disease in HIV-Infected Patients With CD4 Lymphocyte Counts <= 100 Cells/mm3
Clarithromycin
+ Rifabutin
Infections transmises par le sang+20
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Persons with advanced stages of HIV are considered to be at particular risk for developing disseminated MAC disease. The development of an effective regimen for the prevention of disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly the mortality associated with this disease and its treatment. Patients are randomized to receive clarithromycin alone, rifabutin alone, or the two drugs in combination daily. Patients are evaluated every 4 weeks for the first 8 weeks and every 8 weeks thereafter for the duration of the study. Patients are followed for 24 months. Per amendment, a pharmacokinetic substudy will be conducted.
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.1100 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 12 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: PCP prophylaxis. Allowed: GM-CSF or G-CSF. Erythropoietin. Therapies (including antiretrovirals) available through expanded access or treatment IND programs. Other non-experimental therapies available by prescription. Antihistamines other than those specifically excluded. Patients must have: Evidence or diagnosis of HIV infection or a history of an AIDS-defining condition by CDC criteria. CD4 count <= 100 cells/mm3 within 90 days prior to study entry. Two baseline blood sample cultures negative for MAC within 30 days of study entry. No suspected disseminated MAC disease, in the opinion of the clinician. NOTE: Patients with elevated GGT and/or triglycerides are allowed. NOTE: Patients may co-enroll on ACTG 081/981/181, ACTG 175, ACTG 204, ACTG 193, ACTG 241, or other acceptable protocols. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known or suspected tuberculous infection or other non-tuberculous mycobacterial infection requiring chemotherapy or chemoprophylaxis (with the exception of isoniazid prophylaxis alone). NOTE: Patients may enroll who successfully completed tuberculosis (TB) treatment and have been off anti-TB drugs for more than 6 months with no symptoms of mycobacterial infection. Active TB. Known hypersensitivity to study drugs. Malabsorption as defined by persistent diarrhea with more than 8 stools per day for > 6 weeks. Concurrent Medication: Excluded: Frequent (more than once per month), repeated, or continuous treatment courses of quinolones, erythromycin, spiramycin, azithromycin, clarithromycin, or clindamycin. Concomitant terfenadine or astemizole. Prior Medication: Excluded: Prophylaxis with azithromycin, clarithromycin, or rifabutin for more than 4 months.
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 42 sites
UCLA CARE Center CRS
Los Angeles, United StatesChildren's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, United StatesUcsf Aids Crs
San Francisco, United States