Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002108
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
3TC Lamivudine GR109714X Open-Label Program
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
3TC Lamivudine GR109714X Open-Label Program
Status:
COMPLETED
Status Verified Date:
1995-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Patients 12 years and older are randomized to receive one of two doses of 3TC for a duration determined by the patients 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 022895 AMENDMENT Patients enrolled prior to 3195 may remain on their assigned monotherapy dose or change to combination therapy with 3TC and zidovudine
PER 022895 AMENDMENT Patients enrolled prior to 3195 may remain on their assigned monotherapy dose or change to combination therapy with 3TC and zidovudine
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NUCA 3004 | None | None | None |