The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS
Launched by ABBOTT · Aug 30, 2001
Trial Information
Current as of May 09, 2025
Completed
Keywords
ClinConnect Summary
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...
Gender
ALL
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.
About Abbott
Abbott is a global healthcare company dedicated to improving lives through innovative medical technologies, diagnostics, nutrition, and branded generic pharmaceuticals. With a commitment to advancing health and wellness, Abbott conducts clinical trials to evaluate the safety and efficacy of its diverse portfolio of products, which span multiple therapeutic areas, including cardiovascular, diabetes care, and neurology. The company employs rigorous research methodologies and collaborates with healthcare professionals and institutions worldwide to ensure the highest standards of clinical integrity and patient safety. Abbott's mission is to deliver impactful solutions that enhance patient outcomes and contribute to the advancement of global healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Bethesda, Maryland, United States
Patients applied
Trial Officials
Pizzo P
Study Chair
Husson R
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials