Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002320
Status:
COMPLETED
Last Update Posted:
2005-12-12
First Post:
1999-11-02
Brief Title:
A Comparison of Lamivudine and Zidovudine Used Alone and Together in HIV-Infected Patients Who Have Not Used Zidovudine in the Past
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Double-Blind Multicenter Trial to Compare the Safety and Efficacy of Lamivudine 3TC GR109714X Monotherapy Versus Zidovudine AZT Monotherapy Versus 3TC Administered With AZT in the Treatment of HIV-1 Infected Patients Who Are AZT Naive 4 Weeks With CD4 Cell Counts of 200-500 Cellsmm3
Status:
COMPLETED
Status Verified Date:
1994-05
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 evaluate the safety and efficacy of high-dose lamivudine 3TC alone versus zidovudine AZT alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients
PER 022795 AMENDMENT To evaluate the efficacy and safety of both blinded and open-label combination therapy
PER 022795 AMENDMENT To evaluate the efficacy and safety of both blinded and open-label combination therapy
Detailed Description:
Patients are randomized to one of four treatment arms 3TC alone AZT alone low-dose 3TC plus AZT or high-dose 3TC plus AZT Patients receive treatment for 32 weeks with possible extension to 52 weeks
PER 022795 AMENDMENT Patients may continue therapy on AZT and low-dose 3TC on an open-label basis Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates
PER 022795 AMENDMENT Patients may continue therapy on AZT and low-dose 3TC on an open-label basis Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates
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 3001 | None | None | None |