3TC (Lamivudine; GR109714X) Open-Label Program

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Patients must:
• • Have progressive, symptomatic HIV disease.
• • Have a mean CD4 count \<= 99 cells/mm3 for adults and \<= 300 cells/mm3 for children (original design was CD4 count \<= 300 cells/mm3 for both adults and children).
• • Be unable to participate in a controlled trial.
• • Be refractory to or unable to tolerate other therapies.
• • Be able to attend clinic on a monthly schedule.
• • Have consent of parent or guardian if under the age of consent.
• NOTE:
• • If a pregnant or breast-feeding woman requests enrollment, her physician should contact Glaxo staff directly to discuss the case.
• • Practice of unsafe sex.