Two Doses of 3TC (Lamivudine; GR109714X) for Patients 12 Years and Older
Data Collection
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
This study focuses on a medication called 3TC, or Lamivudine, for individuals aged 12 and above. The main goal is to evaluate the effectiveness of two different doses of 3TC, with the duration of treatment decided by the patient's doctor or until the program ends. For those under 12, a lower dose of 3TC is provided. The study is particularly important as it aims to improve treatment options for the condition, offering valuable insights into the use of 3TC. During the study, participants are monitored monthly. In some selected locations, blood samples are collected every three months from patients who test positive for HBsAg. An amendment made on 02/28/95 allows patients enrolled before 03/01/95 to either continue with their current dose of 3TC or switch to a combination therapy involving 3TC and another medication, zidovudine.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 3 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Kern - McNeill International
Morristown, United StatesOpen Kern - McNeill International in Google Maps