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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00001027

Collaborator

Fujisawa Pharmaceutical Co (Industry)

Enrollment

Locations

2.5

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia, Pneumocystis Carinii HIV Infections	Drug: Pentamidine isethionate	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Primary Purpose:

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

Actual Study Completion Date :

Sep 1, 1996

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Usc La Nichd Crs	Los Angeles	California	United States	90033
2	UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS	Los Angeles	California	United States	90095
3	Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.	Oakland	California	United States
4	Children's National Med. Ctr., ACTU	Washington	District of Columbia	United States	20010
5	Howard Univ. Washington DC NICHD CRS	Washington	District of Columbia	United States	20060
6	Chicago Children's CRS	Chicago	Illinois	United States	60614
7	Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease	Chicago	Illinois	United States	60637
8	Tulane/LSU Maternal/Child CRS	New Orleans	Louisiana	United States	70112
9	NYU Med. Ctr., Dept. of Medicine	New York	New York	United States	10016
10	Harlem Hosp. Ctr. NY NICHD CRS	New York	New York	United States	10037
11	SUNY Upstate Med. Univ., Dept. of Peds	Syracuse	New York	United States
12	San Juan City Hosp. PR NICHD CRS	San Juan		Puerto Rico	00936
13	Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS	San Juan		Puerto Rico