The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS
NCT ID: NCT00000971
Last Updated: 2008-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Clarithromycin
Zidovudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
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
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.
3 Months
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Abbott
INDUSTRY
Principal Investigators
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Pizzo P
Role: STUDY_CHAIR
Husson R
Role: STUDY_CHAIR
Locations
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Children's Hosp of Los Angeles
Los Angeles, California, United States
Natl Cancer Institute / HIV / AIDS Malignancy Branch
Bethesda, Maryland, United States
Countries
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References
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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. doi: 10.1016/s0022-3476(05)81380-0.
Other Identifiers
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NCI 91 C-53
Identifier Type: -
Identifier Source: secondary_id
ACTG 178
Identifier Type: -
Identifier Source: org_study_id