A Phase I/II Trial of Parenteral Pentamidine for PCP Prophylaxis in HIV-Infected Children Who Are Intolerant to Oral Trimethoprim-Sulfamethoxazole
Data Collection
Blood-Borne Infections+23
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 1 Months to 6 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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).
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 13 locations
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, United StatesChildren's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, United StatesChildren's National Med. Ctr., ACTU
Washington D.C., United States