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Completed Phase 1 Interventional

A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole

ClinicalTrials.gov ID: NCT00001027

Public ClinicalTrials.gov record NCT00001027. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

A Phase I/II Trial of Parenteral Pentamidine for PCP Prophylaxis in HIV-Infected Children Who Are Intolerant to Oral Trimethoprim-Sulfamethoxazole

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00001027
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
32 participants

Conditions and interventions

Eligibility (public fields only)

Age range
1 Month to 6 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Sep 1996 (Actual)
Last update posted
Nov 1, 2021

Ends 1996

United States locations

U.S. sites
11
U.S. states
5
U.S. cities
7
Facility City State ZIP Site status
Usc La Nichd Crs Los Angeles California 90033 —
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS Los Angeles California 90095 —
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. Oakland California — —
Children's National Med. Ctr., ACTU Washington D.C. District of Columbia 20010 —
Howard Univ. Washington DC NICHD CRS Washington D.C. District of Columbia 20060 —
Chicago Children's CRS Chicago Illinois 60614 —
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease Chicago Illinois 60637 —
Tulane/LSU Maternal/Child CRS New Orleans Louisiana 70112 —
NYU Med. Ctr., Dept. of Medicine New York New York 10016 —
Harlem Hosp. Ctr. NY NICHD CRS New York New York 10037 —
SUNY Upstate Med. Univ., Dept. of Peds Syracuse New York — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00001027, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 1, 2021 · Synced Nov 7, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00001027 live on ClinicalTrials.gov.

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