HIV Infections Clinical Trial
Official title:
A Phase I/II Dose-Ranging, Pharmacokinetic, Drug Interaction, Safety and Preliminary Efficacy Study of Oral Clarithromycin Granules for Suspension, in Combination With Zidovudine or Dideoxyinosine, in the Treatment of Disseminated Mycobacterium Avium Complex Infections in Pediatric Patients With AIDS
To evaluate three doses of clarithromycin in children with AIDS and Mycobacterium avium
complex (MAC) infection who are receiving concurrent antiretroviral therapy.
Before more extensive evaluation of this promising drug for treatment of MAC infection in
children can be done, it is important to study the pharmacokinetics of this drug in this
population, to get information regarding its use in pediatric patients receiving currently
available antiretroviral drugs, and to get information on the antimycobacterial activity of
this drug.
Before more extensive evaluation of this promising drug for treatment of MAC infection in
children can be done, it is important to study the pharmacokinetics of this drug in this
population, to get information regarding its use in pediatric patients receiving currently
available antiretroviral drugs, and to get information on the antimycobacterial activity of
this drug.
Patients that are included are HIV infected and have started zidovudine (AZT) or didanosine
(ddI) at least 4 weeks before entry into this study. Patients continue taking the
medications at prescribed doses. In addition they also take clarithromycin. Patients
continue treatment with AZT or ddI plus clarithromycin for 12 weeks.
;
Primary Purpose: Treatment
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