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Sponsors and Collaborators: |
Abbott National Cancer Institute (NCI) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000971 |
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.
Condition | Intervention | Phase |
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Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Clarithromycin Drug: Zidovudine Drug: Didanosine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
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 |
Estimated Enrollment: | 24 |
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.
Ages Eligible for Study: | 3 Months to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Prior Medication: Required:
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 30 days of study entry:
Active alcohol or drug use sufficient in the opinion of the investigator to prevent adequate compliance with medication regimen and clinic visits.
United States, California | |
Children's Hosp of Los Angeles | |
Los Angeles, California, United States, 90027 | |
United States, Maryland | |
Natl Cancer Institute / HIV / AIDS Malignancy Branch | |
Bethesda, Maryland, United States, 20892 |
Study Chair: | Pizzo P | |
Study Chair: | Husson R |
Study ID Numbers: | ACTG 178, NCI 91 C-53 |
Study First Received: | November 2, 1999 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00000971 |
Health Authority: | Unspecified |
AIDS-Related Opportunistic Infections Mycobacterium avium-intracellulare Infection Didanosine Drug Evaluation |
Drug Interactions Drug Therapy, Combination Acquired Immunodeficiency Syndrome Zidovudine |
Bacterial Infections Opportunistic Infections Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Zidovudine Mycobacterium Infections, Atypical Immunologic Deficiency Syndromes Mycobacterium avium-intracellulare Infection Virus Diseases |
Clarithromycin Gram-Positive Bacterial Infections Didanosine HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Mycobacterium Infections Mycobacterium avium complex infection Retroviridae Infections |
Antimetabolites Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Actinomycetales Infections Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Bacterial Agents Protein Synthesis Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |