The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS
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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 |
---|---|---|
Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Clarithromycin Drug: Zidovudine Drug: Didanosine |
Phase 1 |
Study Type: | Interventional |
Study Design: | Primary Purpose: 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.
![](https://webarchive.library.unt.edu/web/20130315205523im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 3 Months to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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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 |
![](https://webarchive.library.unt.edu/web/20130315205523im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
Publications:
ClinicalTrials.gov Identifier: | NCT00000971 History of Changes |
Other Study ID Numbers: | ACTG 178, NCI 91 C-53 |
Study First Received: | November 2, 1999 |
Last Updated: | July 31, 2008 |
Health Authority: | Unspecified |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections Mycobacterium avium-intracellulare Infection Didanosine Drug Evaluation |
Drug Interactions Drug Therapy, Combination Acquired Immunodeficiency Syndrome Zidovudine |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Mycobacterium Infections Mycobacterium avium-intracellulare Infection Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Mycobacterium Infections, Atypical Didanosine Zidovudine Clarithromycin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 14, 2013