The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycobacterium Avium-Intracellulare Infection; HIV Infections
Intervention: Clarithromycin (Drug); Zidovudine (Drug); Didanosine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s):
Pizzo P, Study Chair
Husson R, Study Chair
Summary
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.
Clinical Details
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
Study design: Treatment
Detailed description:
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.
Eligibility
Minimum age: 3 Months.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
- Prophylaxis treatment for Pneumocystis carinii pneumonia.
- Topical antivirals.
Prior Medication: Required:
- Zidovudine (AZT), 90 - 180 mg/m2 q6h, or didanosine (ddI), 60 - 120 mg/m2 q8h for 4
weeks prior to study entry.
Patients must have the following:
- Diagnosis of AIDS and Mycobacterium avium complex.
- Ability to tolerate therapy with zidovudine or didanosine at specified dosages.
- Written consent from a parent or legal guardian.
- Willing to comply with all procedures and scheduled visits. Relatively stable clinical
condition.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- History of significant depressive disorder.
- History of allergy to macrolide antibiotics.
- Presence of acute bacterial infection or acute onset of opportunistic infection as
listed in protocol.
Patients with the following are excluded:
- Presence of current opportunistic infection other than Mycobacterium avium complex
defined as systemic candidemia, cryptosporidiosis, isosporiasis, toxoplasmosis,
pneumocystosis, salmonellosis, or acute bacterial infection.
Prior Medication:
Excluded within 30 days of study entry:
- Systemic antimycobacterial drugs, myelosuppressive drugs, nephrotoxic agents,
cytotoxic or experimental chemotherapy, or antiviral drugs.
Active alcohol or drug use sufficient in the opinion of the investigator to prevent
adequate compliance with medication regimen and clinic visits.
Locations and Contacts
Children's Hosp of Los Angeles, Los Angeles, California 90027, United States
Natl Cancer Institute / HIV / AIDS Malignancy Branch, Bethesda, Maryland 20892, United States
Additional Information
Click here for more information about Zidovudine Click here for more information about Didanosine Click here for more information about Clarithromycin
Related publications: Husson RN, Ross LA, Sandelli S, Inderlied CB, Venzon D, Lewis LL, Woods L, Conville PS, Witebsky FG, Pizzo PA. Orally administered clarithromycin for the treatment of systemic Mycobacterium avium complex infection in children with acquired immunodeficiency syndrome. J Pediatr. 1994 May;124(5 Pt 1):807-14.
Last updated: June 23, 2005
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