Status:
COMPLETED
The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS
Lead Sponsor:
Abbott
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Mycobacterium Avium-intracellulare Infection
HIV Infections
Eligibility:
All Genders
3-18 years
Phase:
PHASE1
Brief 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 o...
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 in...
Eligibility 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00000971
Last Update
August 4 2008
Active Locations (2)
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1
Children's Hosp of Los Angeles
Los Angeles, California, United States, 90027
2
Natl Cancer Institute / HIV / AIDS Malignancy Branch
Bethesda, Maryland, United States, 20892