DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mycobacterium Avium-intracellulare Infection; HIV Infections

Intervention: Clarithromycin (Drug); Zidovudine (Drug); Didanosine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Pizzo P, Study Chair
Husson R, Study Chair

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.

Clinical Details

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 design: Primary Purpose: Treatment

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

Minimum age: 3 Months. Maximum age: 18 Years. Gender(s): Both.

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.

Locations and Contacts

Children's Hosp of Los Angeles, Los Angeles, California 90027, United States

Natl Cancer Institute / HIV / AIDS Malignancy Branch, Bethesda, Maryland 20892, United States

Additional Information

Click here for more information about Zidovudine

Click here for more information about Didanosine

Related publications:

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.


Last updated: July 31, 2008

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017