Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002389
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Lamivudine Plus Zidovudine Used With and Without 1592U89 in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Double-Blind Parallel-Group Multicenter Trial to Evaluate the Safety and Efficacy of 1592U89 in Combination With Lamivudine 3TC and Zidovudine ZDV Versus 3TCZDV in HIV-1-Infected Antiretroviral Therapy-Naive Subjects With CD4 Counts 100 Cellsmm3
Status:
COMPLETED
Status Verified Date:
1998-11
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 compare the durability of the viral load response following 48 weeks of treatment with 1592U89lamivudine 3TCzidovudine ZDV versus 3TCZDV alone To compare the early antiviral activity following 16 weeks treatment with 1592U893TCZDV versus 3TCZDV alone as demonstrated by the proportion of subjects with viral load 400 copiesml plasma HIV-1 RNA profiles and CD4 profiles To assess the safety and tolerance following 16 and 48 weeks of treatment with 1592U893TCZDV versus 3TCZDV alone
Detailed Description:
This study compares the safety and efficacy of 1592U89 in combination with 3TC and ZDV versus control therapy with 3TC and ZDV alone If a patient has two consecutive HIV-1 RNA measurements of 400 copiesml performed at least one week apart he or she has the option to switch to open-label therapy with 1592U893TCZDV to receive the remaining randomized treatment or to discontinue study medication If this criterion is not met patients continue their randomly assigned therapy until the last patient has completed 48 weeks of therapy Once patients enter the open-label phase investigators may add or substitute non-nucleoside reverse transcriptase inhibitors nucleoside reverse transcriptase inhibitors or protease inhibitors for 3TC andor ZDV according to their standard practice once patients enter the open-label phase
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?: