Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00192634
Status:
COMPLETED
Last Update Posted:
2011-05-25
First Post:
2005-09-13
Brief Title:
A Randomised Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine The STEAL Study
Sponsor:
Kirby Institute
Organization:
Kirby Institute
Study Overview
Official Title:
A Randomised Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine The STEAL Study
Status:
COMPLETED
Status Verified Date:
2011-05
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:
Combination antiretroviral therapy for the treatment of HIV has a high pill burden Two dual-tablets abacavir-lamivudine and tenofovir-emtricitabine are now licensed in the United States and will be available in Australia in December 2005 Data available suggest that the potency of these tablets are similar in controlling replication of the HIV virus but not have not been directly compared in regard to clinically significant toxicities We therefore aim to compare the overall safety and efficacy of the two dual-tablets over a 2 year period in HIV infected adults We hypothesise that the two dual-NRTI treatments will be similar in efficacy and safety
Detailed Description:
The aim of this study is to compare the overall safety and efficacy of two dual-NRTI once daily tablets over a 2 year period in HIV infected adults
The study is a randomised multi-centre 2 year study of two dual NRTI once daily tablets in subjects with HIV currently taking two individual NRTIs as part of their therapy 350 subjects will be randomised in a 11 ratio to either
1 tenofovir TDF 300mg emtricitabine FTC 200mg OR
2 abacavir ABC 600mg lamivudine 3TC 300mg Subjects will cease their current individual NRTI treatment commence their randomised dual NRTI tablet and continue on their current NNRTI or PI therapy
Subjects will be stratified by the type of NRTI they are currently taking ABC TDF or other whether they are currently taking a protease inhibitor yes or no and by the site where they are randomised A study plan is enclosed
Subjects will be closely monitored at 1 month and then every 3 months until week 96 for safety by evaluating the incidence and severity of adverse effectsabnormal laboratory parameters Study investigations enclosed It is optional whether subjects also provide plasma serum and cells PBMCs for storage These samples will be available for analysis for sub-studies agreed to through the IVRN expression of interest network
The study is a randomised multi-centre 2 year study of two dual NRTI once daily tablets in subjects with HIV currently taking two individual NRTIs as part of their therapy 350 subjects will be randomised in a 11 ratio to either
1 tenofovir TDF 300mg emtricitabine FTC 200mg OR
2 abacavir ABC 600mg lamivudine 3TC 300mg Subjects will cease their current individual NRTI treatment commence their randomised dual NRTI tablet and continue on their current NNRTI or PI therapy
Subjects will be stratified by the type of NRTI they are currently taking ABC TDF or other whether they are currently taking a protease inhibitor yes or no and by the site where they are randomised A study plan is enclosed
Subjects will be closely monitored at 1 month and then every 3 months until week 96 for safety by evaluating the incidence and severity of adverse effectsabnormal laboratory parameters Study investigations enclosed It is optional whether subjects also provide plasma serum and cells PBMCs for storage These samples will be available for analysis for sub-studies agreed to through the IVRN expression of interest network
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTRN012605000505606 | None | None | None |