A Randomized Comparative Study of Combined Zidovudine-Lamivudine (3TC) vs. the Better of ddI Monotherapy vs. Zidovudine Plus Ddl in Symptomatic HIV-1 Infected Children
Lamivudine
+ Zidovudine
+ Didanosine
Infections transmises par le sang+14
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile. Patients are randomized to receive oral 3TC/AZT, ddI/AZT, or ddI alone for at least 24 months. PER AMENDMENT 4/29/96: NOTE: Randomization to ZDV+ddI arm was terminated in Spring of 1996 based upon the results of ACTG 152. Patients on that arm will continue on blinded study drug and will be followed until the end of the study.
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.740 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 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 Concurrent Medication: Allowed: IVIG. Prophylaxis for opportunistic infection. EPO. G-CSF or GM-CSF. Patients must have: Symptomatic HIV infection. Less than 56 days of prior antiretroviral therapy. Consent of parent or guardian. NOTE: Co-enrollment on ACTG 219, ACTG 220, and certain ACTG opportunistic infection protocols is permitted. Prior Medication: Allowed: Up to 56 days of prior antiretroviral therapy. Prior immunomodulator therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malignancy. Hypersensitivity to a nucleoside analog. Current grade 2 or higher amylase/lipase toxicity or grade 3 or 4 other toxicity. PER AMENDMENT 4/29/96: Active opportunistic infection and/or serious bacterial infection at the time of entry. Concurrent Medication: Excluded: Any other anti-HIV therapy. Megestrol acetate ( Megace ). Probenecid. IV pentamidine. Human growth hormone ( hGH ). Systemic corticosteroids for more than 2 weeks. Prior Medication: Excluded: Investigational drug therapy within 14 days prior to study entry.
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 91 sites
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, United StatesOuvrir Univ of Alabama at Birmingham Schl of Med / Pediatrics dans Google MapsArkansas Children's Hosp
Little Rock, United StatesUCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, United StatesLong Beach Memorial (Pediatric)
Long Beach, United States