search
Back to results

The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS

Primary Purpose

Mycobacterium Avium-intracellulare Infection, HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Clarithromycin
Zidovudine
Didanosine
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycobacterium Avium-intracellulare Infection focused on measuring AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Didanosine, Drug Evaluation, Drug Interactions, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine

Eligibility Criteria

3 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hosp of Los Angeles
  • Natl Cancer Institute / HIV / AIDS Malignancy Branch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
July 31, 2008
Sponsor
Abbott
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00000971
Brief Title
The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycobacterium Avium-intracellulare Infection, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Didanosine, Drug Evaluation, Drug Interactions, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pizzo P
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Husson R
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hosp of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Natl Cancer Institute / HIV / AIDS Malignancy Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8176574
Citation
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.
Results Reference
background

Learn more about this trial

The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS

We'll reach out to this number within 24 hrs