The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS
Completed · Phase 1
Conditions studied: Mycobacterium Avium-intracellulare Infection, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00000971
- Run by
- Abbott
- People needed
- 24
- Last updated by the study team
- 2008-08-04
Who can join
Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Children's Hosp of Los Angeles — Los Angeles, California, United States
- Natl Cancer Institute / HIV / AIDS Malignancy Branch — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.