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NCT00000971 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000971
Other study ID # ACTG 178
Secondary ID NCI 91 C-53
Status Completed
Phase Phase 1
First received November 2, 1999
Last updated July 31, 2008

Study information
Verified date October 1996
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 18 Years
Eligibility 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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Clarithromycin

• Zidovudine

• Didanosine

Locations
Country Name City State
United States Natl Cancer Institute / HIV / AIDS Malignancy Branch Bethesda Maryland
United States Children's Hosp of Los Angeles Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
Abbott National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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