NCT00000971

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

August 4, 2008

Status Verified

October 1, 1996

First QC Date

November 2, 1999

Last Update Submit

July 31, 2008

Conditions

Mycobacterium Avium-intracellulare InfectionHIV Infections

Keywords

AIDS-Related Opportunistic InfectionsMycobacterium avium-intracellulare InfectionDidanosineDrug EvaluationDrug InteractionsDrug Therapy, CombinationAcquired Immunodeficiency SyndromeZidovudine

Interventions

ClarithromycinDRUG
ZidovudineDRUG
DidanosineDRUG

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hosp of Los Angeles

Los Angeles, California, 90027, United States

Location

Natl Cancer Institute / HIV / AIDS Malignancy Branch

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Husson RN, Ross LA, Sandelli S, Inderlied CB, Venzon D, Lewis LL, Woods L, Conville PS, Witebsky FG, Pizzo PA. Orally administered clarithromycin for the treatment of systemic Mycobacterium avium complex infection in children with acquired immunodeficiency syndrome. J Pediatr. 1994 May;124(5 Pt 1):807-14. doi: 10.1016/s0022-3476(05)81380-0.

    PMID: 8176574BACKGROUND

MeSH Terms

Conditions

Mycobacterium avium-intracellulare InfectionHIV InfectionsAIDS-Related Opportunistic InfectionsAcquired Immunodeficiency Syndrome

Interventions

ClarithromycinZidovudineDidanosine

Condition Hierarchy (Ancestors)

Mycobacterium Infections, NontuberculousMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesInosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingRibonucleosides

Study Officials

  • Pizzo P

    STUDY CHAIR

  • Husson R

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

August 4, 2008

Record last verified: 1996-10

Locations

US(2)