Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005017
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-04-03
Brief Title:
Effectiveness and Safety of EpivirZiagenZerit 3TCABCd4T Versus EpivirZiagenSustiva 3TCABCEFV Versus EpivirZiagenAgeneraseNorvir 3TCABCAPVRTV in HIV Patients Who Have Never Received Treatment
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase IV Open-Label Randomized Study to Compare the Efficacy and Safety of EpivirZiagenZerit 3TCABCd4T Versus EpivirZiagenSustiva 3TCABCEFV Versus EpivirZiagenAgeneraseNorvir 3TCABCAPVRTV for 96 Weeks in the Treatment of HIV-1 Infected Subjects Who Are Antiretroviral Therapy Naive
Status:
UNKNOWN
Status Verified Date:
2001-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this study is to see how effective and safe it is to give 1 of the 3 following treatments to patients who may not have received anti-HIV treatment 1 lamivudine 3TCabacavir ABCstavudine d4T 2 3TCABCefavirenz EFV or 3 3TCABCamprenavir APVritonavir RTV
Detailed Description:
Patients are randomized to initiate antiretroviral therapy in 1 of 3 treatment groups Within each group they are stratified based on HIV-1 plasma RNA levels
Group 1 Patients receive 3TCABCd4T Group 2 Patients receive 3TCABCEFV and Group 3 Patients receive 3TCABCAPVRTV
Treatment continues for 96 weeks Blood samples are collected to measure plasma HIV RNA and CD4 counts and patients are assessed regularly In the event of incomplete viral suppression or virologic failure patients will be switched to secondary therapy
Group 1 Patients receive 3TCABCd4T Group 2 Patients receive 3TCABCEFV and Group 3 Patients receive 3TCABCAPVRTV
Treatment continues for 96 weeks Blood samples are collected to measure plasma HIV RNA and CD4 counts and patients are assessed regularly In the event of incomplete viral suppression or virologic failure patients will be switched to secondary therapy
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 |
|---|---|---|---|
| ESS40001 | None | None | None |