3TC (Lamivudine; GR109714X) Open-Label Program
|Study Design:||Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||3TC (Lamivudine; GR109714X) Open-Label Program|
Patients 12 years and older are randomized to receive one of two doses of 3TC for a duration determined by the patient's physician or until termination of the program. Patients < 12 years receive a lower dose of 3TC. Patients are followed monthly. For selected sites only, serum samples are collected every 3 months from patients identified as HBsAg positive.
PER 02/28/95 AMENDMENT: Patients enrolled prior to 3/1/95 may remain on their assigned monotherapy dose or change to combination therapy with 3TC and zidovudine.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002108
|United States, New Jersey|
|Kern - McNeill International|
|Morristown, New Jersey, United States, 07960|