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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

This study has been completed.

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Fujisawa Pharmaceutical Co
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001027
  Purpose

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.


Condition Intervention Phase
Pneumonia, Pneumocystis Carinii
HIV Infections
Drug: Pentamidine isethionate
Phase I

MedlinePlus related topics:   AIDS    Pneumonia   

Drug Information available for:   Sulfamethoxazole    Trimethoprim    Trimethoprim-sulfamethoxazole combination    Pentamidine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase I/II Trial of Parenteral Pentamidine for PCP Prophylaxis in HIV-Infected Children Who Are Intolerant to Oral Trimethoprim-Sulfamethoxazole

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   32

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
Ages Eligible for Study:   1 Month to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001027

Locations
United States, Alabama
Univ of Alabama at Birmingham Schl of Med / Pediatrics    
      Birmingham, Alabama, United States, 35294
United States, California
UCLA Med Ctr / Pediatric    
      Los Angeles, California, United States, 900951752
Los Angeles County - USC Med Ctr    
      Los Angeles, California, United States, 90033
United States, Colorado
Children's Hosp of Denver    
      Denver, Colorado, United States, 802181088
United States, District of Columbia
Howard Univ Hosp    
      Washington, District of Columbia, United States, 20060
Children's Hosp of Washington DC    
      Washington, District of Columbia, United States, 200102916
United States, Illinois
Chicago Children's Memorial Hosp    
      Chicago, Illinois, United States, 606143394
Univ of Chicago Children's Hosp    
      Chicago, Illinois, United States, 606371470
United States, Louisiana
Tulane Univ / Charity Hosp of New Orleans    
      New Orleans, Louisiana, United States, 701122699
United States, New Jersey
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl    
      Newark, New Jersey, United States, 071072198
United States, New York
Harlem Hosp Ctr    
      New York, New York, United States, 10037
Cornell Univ Med College    
      New York, New York, United States, 10021
Bellevue Hosp / New York Univ Med Ctr    
      New York, New York, United States, 10016
Mount Sinai Med Ctr    
      New York, New York, United States, 10029
Children's Hosp Pact Prog / Children's Hosp of Buffalo    
      Buffalo, New York, United States, 14222
Beth Israel Med Ctr / Pediatrics    
      New York, New York, United States, 10003
Puerto Rico
San Juan City Hosp    
      San Juan, Puerto Rico, 009367344

Sponsors and Collaborators

Investigators
Study Chair:     Van Dyke R    
Study Chair:     Pramberg J    
  More Information


Click here for more information about Pentamidine isethionate  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   ACTG 189
First Received:   November 2, 1999
Last Updated:   July 29, 2008
ClinicalTrials.gov Identifier:   NCT00001027
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Pneumonia, Pneumocystis carinii  
Pentamidine  
Acquired Immunodeficiency Syndrome  
AIDS-Related Complex  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Trimethoprim
Clotrimazole
Miconazole
Trimethoprim-Sulfamethoxazole Combination
Pneumonia, Pneumocystis
Mycoses
Respiratory Tract Infections
Respiratory Tract Diseases
Pentamidine
Retroviridae Infections
Lung Diseases, Fungal
Sulfamethoxazole
Pneumocystosis
Acquired Immunodeficiency Syndrome
Tioconazole
AIDS-Related Complex
Immunologic Deficiency Syndromes
Virus Diseases
Folic Acid
Pneumocystis Infections
HIV Infections
Lung Diseases
Sexually Transmitted Diseases
Pneumonia

Additional relevant MeSH terms:
Anti-Infective Agents
Trypanocidal Agents
RNA Virus Infections
Antiprotozoal Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Folic Acid Antagonists
Renal Agents
Infection
Pharmacologic Actions
Antimalarials
Antiparasitic Agents
Antifungal Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on December 03, 2008




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