Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
NCT00001027 · View on ClinicalTrials.gov ↗
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?
Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00001027 reports 13 study locations spanning 6 distinct geographic areas — top geographies include California, New York, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00001027?
The interventions under investigation include: Pentamidine isethionate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00001027?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.