A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
A Phase I/II Trial of Parenteral Pentamidine for PCP Prophylaxis in HIV-Infected Children Who Are Intolerant to Oral Trimethoprim-Sulfamethoxazole
2 other identifiers
interventional
32
2 countries
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
September 1, 1996
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 1, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Steroids and intravenous immune globulin (IVIG).
- Patients must have:
- Documented HIV infection.
- Need for PCP prophylaxis.
- Known intolerance to trimethoprim - sulfamethoxazole (TMP-SMX).
- One of the following required conditions:
- NOTE:
- Co-enrollment in other ACTG pediatric studies is permitted.
- Consent of parent or guardian is required.
- Prior Medication:
- Allowed:
- Prior pentamidine.
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Active PCP.
- Pancreatitis defined as amylase elevation associated with an elevated lipase that is \> 2 x upper limit of normal.
- Prior Medication:
- Excluded:
- TMP-SMX or dapsone within 7 days prior to study entry (toxicities to TMP-SMX or dapsone must be clearly resolving).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Usc La Nichd Crs
Los Angeles, California, 90033, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, 90095, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, 20010, United States
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, 20060, United States
Chicago Children's CRS
Chicago, Illinois, 60614, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, 60637, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, 10016, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, 10037, United States
SUNY Upstate Med. Univ., Dept. of Peds
Syracuse, New York, United States
San Juan City Hosp. PR NICHD CRS
San Juan, 00936, Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Van Dyke R
- STUDY CHAIR
Pramberg J