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
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.
Interventional
Primary Purpose: Treatment
Pizzo P
Study Chair
Unspecified
ACTG 178
NCT00000971
Name | Location |
---|---|
Children's Hosp of Los Angeles | Los Angeles, California 90027 |
Natl Cancer Institute / HIV / AIDS Malignancy Branch | Bethesda, Maryland 20892 |