Completed

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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What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections+22

+ Urogenital Diseases

+ Genital Diseases

From 3 Months to 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorAbbott
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleA 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
NCT00000971
Principal SponsorAbbott
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 3 Months to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAcquired Immunodeficiency SyndromeActinomycetales InfectionsBacterial Infections and MycosesBacterial InfectionsCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMycobacterium InfectionsMycobacterium Infections, NontuberculousOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralMycobacterium avium-intracellulare InfectionHIV InfectionsLentivirus InfectionsGram-Positive Bacterial InfectionsAIDS-Related Opportunistic Infections

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Children's Hosp of Los Angeles

Los Angeles, United StatesOpen Children's Hosp of Los Angeles in Google Maps
Suspended

Natl Cancer Institute / HIV / AIDS Malignancy Branch

Bethesda, United States
Completed2 Study Centers