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	Treatment or Intervention	Phase
Pneumonia, Pneumocystis carinii HIV Infections	Drug: Pentamidine isethionate	Phase I

Further Study Details: 

Expected Total Enrollment:  32

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.

Ages Eligible for Study:  1 Month   -   6 Years,  Genders Eligible for Study:  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).

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

Study chairs or principal investigators

Van Dyke R,  Study Chair
Pramberg J,  Study Chair

Study ID Numbers:  ACTG 189
Record last reviewed:  October 1996
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00001027
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08