3TC (Lamivudine; GR109714X) Open-Label Program

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002108
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1995

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002108 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
3TC (Lamivudine; GR109714X) Open-Label Program
3TC (Lamivudine; GR109714X) Open-Label Program

To make lamivudine (3TC) available to patients with progressive, symptomatic HIV disease who cannot participate in a controlled clinical trial and who are refractory or unable to tolerate other therapies. To collect data pertaining to the safety of 3TC at two dose levels. To evaluate the effect of 3TC on markers of hepatitis B in co-infected patients at five to ten selected sites.

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.

Interventional
Not Provided
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Lamivudine
  • Drug: Zidovudine
Not Provided
Pluda J, Cooley T, Montaner J, McCaffrey R, Wainberg M, Yarchoan R. Phase I/II study of 3TC (GR109714X) in adults with ARC or AIDS. Int Conf AIDS. 1993 Jun 6-11;9(1):69 (abstract no WS-B26-2)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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.

Both
3 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002108
129D, NUCA 3004
Not Provided
Not Provided
Glaxo Wellcome
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
November 1995

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP