Ignite Creation Date:
2024-05-06 @ 12:59 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01701882
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2012-09-19
Brief Title:
A Pilot Study to Assess the Feasibility of Switching Individuals Receiving Atripla With Continuing Central Nervous System CNS Toxicity to a Fixed Dose Combination of TenofovirEmtricitabineRilpivirine
Sponsor:
St Stephens Aids Trust
Organization:
St Stephens Aids Trust
Study Overview
Official Title:
A Pilot Study to Assess the Feasibility of Switching Individuals Receiving Atripla With Continuing Central Nervous System CNS Toxicity to a Fixed Dose Combination of TenofovirEmtricitabineRilpivirine
Status:
COMPLETED
Status Verified Date:
2017-07
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:
The purpose of the study is to investigate the benefits of switching away from efavirenz which patients are taking in combination with Kivexa or as part of the combination pill Atripla in patients with central nervous system side effects such as insomnia difficulty with sleeping bad dreams etc The investigators in this study will investigate the effect of switching to a single tablet regimen Eviplera containing tenofovir emtricitabine and rilpivirine If patients are currently taking Atripla rilpivirine will be the only new component of the combination
Rilpivirine is a drug for HIV treatment licensed for first-line treatment In combination with Truvada it showed fewer side effects when compared to efavirenz in 2 other clinical studies where patients were starting HIV treatment for the first time
This study will also investigate the safety in terms of other side effects and the routine blood tests which we ordinarily use to monitor your treatment and monitor effectiveness your viral load and CD4 counts when you switch treatment to tenofoviremtricitabinerilpivirine
Rilpivirine is a drug for HIV treatment licensed for first-line treatment In combination with Truvada it showed fewer side effects when compared to efavirenz in 2 other clinical studies where patients were starting HIV treatment for the first time
This study will also investigate the safety in terms of other side effects and the routine blood tests which we ordinarily use to monitor your treatment and monitor effectiveness your viral load and CD4 counts when you switch treatment to tenofoviremtricitabinerilpivirine
Detailed Description:
None
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