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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia, Pneumocystis Carinii; HIV Infections

Intervention: Pentamidine isethionate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Van Dyke R, Study Chair
Pramberg J, Study Chair

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.

Clinical Details

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

Study design: Primary Purpose: Treatment

Detailed description: 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.

Eligibility

Minimum age: 1 Month. Maximum age: 6 Years. Gender(s): Both.

Criteria:

Inclusion Criteria 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:

- Known intolerance or allergy to dapsone; G6PD deficiency; history of serious or

life-threatening reaction to TMP-SMX; exclusion from protocol ACTG 179; election by parent not to enroll child on ACTG 179; or receiving medical care at sites not participating in ACTG 179. NOTE:

- Co-enrollment in other ACTG pediatric studies is permitted.

Consent of parent or guardian is required. Prior Medication: Allowed:

- Prior pentamidine.

Exclusion Criteria 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).

Locations and Contacts

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

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS, Los Angeles, California 90095, United States

Usc La Nichd Crs, Los Angeles, California 90033, 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, District of Columbia 20010, United States

Howard Univ. Washington DC NICHD CRS, Washington, 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

Harlem Hosp. Ctr. NY NICHD CRS, New York, New York 10037, United States

NYU Med. Ctr., Dept. of Medicine, New York, New York 10016, United States

SUNY Upstate Med. Univ., Dept. of Peds, Syracuse, New York, United States

Additional Information

Click here for more information about Pentamidine isethionate


Last updated: March 28, 2012

Page last updated: August 23, 2015

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