Search / Trial NCT00002108

3TC (Lamivudine; GR109714X) Open-Label Program

Launched by GLAXO WELLCOME · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents Zidovudine

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.

About Glaxo Wellcome

Glaxo Wellcome, a leading global biopharmaceutical company, is dedicated to advancing healthcare through innovative research and development of new therapies. With a strong focus on addressing unmet medical needs, Glaxo Wellcome combines scientific excellence with a commitment to improving patient outcomes across various therapeutic areas, including respiratory, infectious diseases, and oncology. The company is recognized for its robust clinical trial portfolio, leveraging cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. Glaxo Wellcome upholds the highest ethical standards in clinical research, ensuring patient safety and integrity throughout the trial process.

Locations

Morristown, New Jersey, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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