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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ClinicalTrials.gov Identifier: NCT00000971 |
Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : August 4, 2008
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Mycobacterium Avium-intracellulare Infection HIV Infections | Drug: Clarithromycin Drug: Zidovudine Drug: Didanosine | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 24 participants |
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 |


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Ages Eligible for Study: | 3 Months to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000971
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 |
ClinicalTrials.gov Identifier: | NCT00000971 |
Other Study ID Numbers: |
ACTG 178 NCI 91 C-53 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | August 4, 2008 |
Last Verified: | October 1996 |
AIDS-Related Opportunistic Infections Mycobacterium avium-intracellulare Infection Didanosine Drug Evaluation |
Drug Interactions Drug Therapy, Combination Acquired Immunodeficiency Syndrome Zidovudine |
Infection Communicable Diseases Mycobacterium Infections Mycobacterium avium-intracellulare Infection Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Mycobacterium Infections, Nontuberculous Zidovudine Didanosine Clarithromycin Antimetabolites |
Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Anti-Bacterial Agents Protein Synthesis Inhibitors Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |