A Phase I/II Trial of Parenteral Pentamidine for PCP Prophylaxis in HIV-Infected Children Who Are Intolerant to Oral Trimethoprim-Sulfamethoxazole
Collecte de données
Infections transmises par le sang+23
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.32 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 1 mois à 6 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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).
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 13 sites
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