3TC (Lamivudine; GR109714X) Open-Label Program
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Lamivudine (Drug); Zidovudine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Glaxo Wellcome
Summary
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.
Clinical Details
Official title: 3TC (Lamivudine; GR109714X) Open-Label Program
Study design: Treatment, Open Label, Safety Study
Detailed description:
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.
Eligibility
Minimum age: 3 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Kern - McNeill International, Morristown, New Jersey 07960, United States
Additional Information
Related publications: 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)
Last updated: June 23, 2005
|
