A Multicenter, Open-Labeled, 96-Week Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Indinavir in Combination With Stavudine and Lamivudine in Pediatric Patients With HIV-1 Infection
Indinavir sulfate
+ Lamivudine
+ Stavudine
Infections transmises par le sang+11
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
In this multicenter, open-label study patients receive a combined drug regimen of indinavir, stavudine, and lamivudine over 48 weeks. Patients are evaluated at Weeks 0, 2, 4, every 4 weeks until Week 24, and every 8 weeks thereafter until study completion. [AS PER AMENDMENT 4/27/99: The study has been extended for an additional 48 weeks for a total of 96 weeks.]
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.24 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 3 à 15 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 Your child may be eligible for this study if he/she: Is 3 - 15 years old and has consent of a parent or legal guardian who is able to return with the child for follow-up visits. Is HIV-positive. Is generally healthy. Is able to swallow medication in capsule form. Has never taken d4T or has never taken 3TC. Agrees to use barrier methods of birth control (such as condoms) during the study. The pill is not allowed during the study. Exclusion Criteria Your child will not be eligible for this study if he/she: Has a serious infection at the time of study entry. Has a history of severe diarrhea. Is unable to take any of the medications in this study for any reason. Has a history of certain serious illnesses. Has taken any protease inhibitors (PIs). Has taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz (EFV), within 2 weeks prior to study entry. Has taken certain medications. Is pregnant or breast-feeding.
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 19 sites
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, United StatesOuvrir UCSD Med Ctr / Pediatrics / Clinical Sciences dans Google MapsUCSF / Moffitt Hosp - Pediatric
San Francisco, United StatesYale Univ Med School
New Haven, United StatesUniv of Florida Gainesville
Gainesville, United States