HIV Infections, Mycobacterium Avium-intracellulare Infection
Conditions
Keywords
AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Didanosine, Drug Evaluation, Drug Interactions, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine
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.
Interventions
DRUGClarithromycin
DRUGZidovudine
DRUGDidanosine
Sponsors
National Cancer Institute (NCI)
Abbott
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed