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NCT00001027 · ClinicalTrials.gov registry record · Phase 1
A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
A Phase 1 study of HIV Infections and Pneumonia, Pneumocystis Carinii, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 13
- Study locations
NCT00001027 is a Phase 1 study of HIV Infections and Pneumonia, Pneumocystis Carinii that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 32 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The trial reports 13 study locations across 6 states.
The verdict
NCT00001027, a Phase 1 study of HIV Infections and Pneumonia, Pneumocystis Carinii, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 13
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Pentamidine isethionate
Study Locations (13)
California
- Usc La Nichd Crs - Los Angeles
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS - Los Angeles
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. - Oakland
New York
- NYU Med. Ctr., Dept. of Medicine - New York
- Harlem Hosp. Ctr. NY NICHD CRS - New York
- SUNY Upstate Med. Univ., Dept. of Peds - Syracuse
District of Columbia
- Children's National Med. Ctr., ACTU - Washington D.C.
- Howard Univ. Washington DC NICHD CRS - Washington D.C.
Illinois
- Chicago Children's CRS - Chicago
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease - Chicago
Other
- San Juan City Hosp. PR NICHD CRS - San Juan
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS - San Juan
Louisiana
- Tulane/LSU Maternal/Child CRS - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Est. Completion | 1996-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001027
The ClinicalTrials.gov registry entry for NCT00001027 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Pentamidine isethionate is the first listed.
NCT00001027 reports 13 study locations spanning 6 distinct geographic areas - top geographies include California, New York, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT00001027 about?
NCT00001027 is a clinical study titled "A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole". 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 p...
What is the current status of trial NCT00001027?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. Estimated completion is 1996-09.
What conditions does trial NCT00001027 study?
This clinical trial studies the following conditions: HIV Infections, Pneumonia, Pneumocystis Carinii.
What interventions are being tested in trial NCT00001027?
The interventions under investigation include: Pentamidine isethionate (DRUG).
Who is sponsoring clinical trial NCT00001027?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001027 being conducted?
This trial has 13 study locations across California, District of Columbia, Illinois, Louisiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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