A Phase II Study to Evaluate Pharmacokinetics, Safety, Tolerance and Activity of Dideoxycytidine (ddC) Administered in Combination With Zidovudine (AZT) in Stable, AZT-Treated Pediatric Patients With HIV Infection
Collecte de données
Infections transmises par le sang+14
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone. Patients are stratified according to duration of ongoing AZT therapy and are randomized to receive AZT either alone or in combination with ddC. Patients receive therapy until the last patient enrolled completes 32 weeks of therapy. The study may be extended for two additional 32-week periods on an optional basis.
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.180 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 mois à 12 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: Recommended: * PCP prophylaxis. Allowed: * Intravenous and/or intramuscular immunoglobulin. * Acyclovir (no more than 30 mg/kg/day PO). * Ketoconazole (no more than 10 mg/kg/day). * Nystatin. * Aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs, sedatives, and barbiturates, not to exceed 72 hours. * Isoniazid in combination with pyridoxine, provided there is no evidence of peripheral neuropathy. * Trimethoprim / sulfamethoxazole. * Amphotericin B (no more than 1 mg/kg for 5 days/week). * Aerosolized ribavirin for bronchiolitis. * Hematopoietic agents. * Other drugs with little nephro-, hepato-, or cytotoxicity. * Nutritional support for HIV wasting syndrome or malnutrition. Patients must have: * HIV infection. * Ongoing stable AZT therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: * Disease progression while on AZT, to the extent that the patient meets the criteria for advanced disease protocols. * Known allergy or sensitivity to ddC. * Cardiomyopathy. Concurrent Medication: Excluded: * Biologic modifiers other than IVIG, steroids, or hematopoietic agents. * Investigational medications unless approved by protocol chair. * Medications known to cause pancreatitis (unless ddC is interrupted while these medications are given). Patients with the following prior conditions are excluded: * History of intolerance or toxicity to AZT. * History of symptomatic pancreatitis. * History of peripheral neuropathy or abnormal nerve conduction velocity test. Prior Medication: Excluded: * Antiretroviral agents other than AZT within 2 weeks of study entry. Required: * Ongoing stable AZT therapy for more than 6 weeks duration.
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 47 sites
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, United StatesOuvrir Long Beach Memorial Med. Ctr., Miller Children's Hosp. dans Google MapsUsc La Nichd Crs
Los Angeles, United StatesUCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, United StatesChildren's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, United States