A Phase 1 interventional study of Pentamidine isethionate in Pneumonia, Pneumocystis Carinii and HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 13 sites in 2 countries. Open to participants aged 1 Month to 6 Years. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment
Primary: To compare the pharmacokinetics of biweekly and monthly dose regimens of intravenous pentamidine in HIV-infected infants and children who require PCP prophylaxis and who are intolerant to oral trimethoprim - sulfamethoxazole. To determine the safety and tolerance of these regimens in this patient population.
Secondary: To obtain information on the rate of PCP breakthrough in infants and children receiving parenteral pentamidine prophylaxis.
Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk. In children younger than 5 years of age with intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful alternative.
Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk. In children younger than 5 years of age with intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful alternative.
Thirty-two children are randomized to one of two treatment arms. Patients receive pentamidine on either a biweekly or a monthly treatment schedule. Treatment continues until the last child enrolled has received at least 6 months of pentamidine. Patients are stratified according to age \< 24 months or age >= 24 months. Steady-state pharmacokinetics will be examined in a subsample of 20 patients.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 32 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
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Concurrent Medication:
Allowed:
Patients must have:
One of the following required conditions:
NOTE:
Consent of parent or guardian is required.
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Prior Medication:
Excluded:
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)