Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Fujisawa Pharmaceutical Co

Conditions:

Pneumonia, Pneumocystis Carinii

HIV Infections

Eligibility:

All Genders

1-6 years

Phase:

PHASE1

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 ora...

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 ...

Eligibility 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).

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

September 1 1996

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT00001027

End Date

September 1 1996

Last Update

November 1 2021

Active Locations (13)

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Page 1 of 4 (13 locations)

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 D.C., District of Columbia, United States, 20010