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”

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.

Study Type: Interventional

Study Design: Treatment

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.

Intervention(s) in this Clinical Trial

• Drug: Clarithromycin
• Drug: Zidovudine
• Drug: Didanosine

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Months

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Overall Clinical Trial Officials and Contacts

Pizzo P Study Chair   

Information obtained from ClinicalTrials.gov on January 06, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00000971

Study ID Number: ACTG 178

ClinicalTrials.gov Identifier: NCT00000971

Health Authority: Unspecified

Click here for more information about Zidovudine

Click here for more information about Didanosine

Click here for more information about Clarithromycin