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The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS
This study has been completed.
First Received: November 2, 1999   Last Updated: July 31, 2008   History of Changes
Sponsor: Abbott
Collaborator: National Cancer Institute (NCI)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000971
  Purpose

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 I

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 24
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000971

Locations
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
Sponsors and Collaborators
Abbott
Investigators
Study Chair: Pizzo P
Study Chair: Husson R
  More Information

Additional Information:
Publications:
Study ID Numbers: ACTG 178, NCI 91 C-53
Study First Received: November 2, 1999
Last Updated: July 31, 2008
ClinicalTrials.gov Identifier: NCT00000971     History of Changes
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:
Bacterial Infections
Antimetabolites
Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Infection
Reverse Transcriptase Inhibitors
Anti-Bacterial Agents
Clarithromycin
Gram-Positive Bacterial Infections
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Actinomycetales Infections
Mycobacterium Infections, Atypical
Pharmacologic Actions
Mycobacterium avium-intracellulare Infection
Virus Diseases
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 27, 2009