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.
Sponsor:
Collaborator:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000971
First received: November 2, 1999
Last updated: July 31, 2008
Last verified: October 1996
  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 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Infection
Communicable Diseases
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, Nontuberculous
Zidovudine
Didanosine
Clarithromycin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents

ClinicalTrials.gov processed this record on September 18, 2014