Ignite Creation Date:
2024-05-05 @ 10:49 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01195467
Status:
COMPLETED
Last Update Posted:
2014-11-26
First Post:
2010-09-03
Brief Title:
Atripla to Raltegravir Switch Study for CNS Toxicity
Sponsor:
St Stephens Aids Trust
Organization:
St Stephens Aids Trust
Study Overview
Official Title:
A Phase III Open-label Single Centre Single-arm Pilot Study to Assess the Feasibility of Switching Individuals Receiving Efavirenz With Continuing Central Nervous System CNS Toxicity to Raltegravir
Status:
COMPLETED
Status Verified Date:
2014-11
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:
SSAT036
Brief Summary:
The purpose of the study is to investigate the benefits of switching away from efavirenz 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 will investigate the effect of switching to Truvada a combination pill of tenofovir and emtricitabine the other two components of Atripla plus raltegravir
Raltegravir is a licensed drug for HIV treatment which showed side effects were fewer in number 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 the investigators ordinarily use to monitor your treatment and monitor effectiveness your viral load and CD4 counts when you switch treatment from Atripla to Truvadaraltegravir
Raltegravir is a licensed drug for HIV treatment which showed side effects were fewer in number 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 the investigators ordinarily use to monitor your treatment and monitor effectiveness your viral load and CD4 counts when you switch treatment from Atripla to Truvadaraltegravir
Detailed Description:
The majority of individuals who commence treatment for HIV in the UK start with a regimen that includes EFV in combination with other antiretrovirals These regimens are convenient once daily dosing and highly efficacious However EFV has several potential drawbacks including continued CNS toxicity the potential for teratogenesis and a low barrier to the development of virological resistance
Clinically controlled trials frequently reported undesirable nervous system side effects in patients receiving 600 mg EFV with other antiretroviral agents including dizziness insomnia somnolence impaired concentration and abnormal dreaming CNS symptoms of moderate to severe intensity were experienced by 194 of patients compared to 90 of patients receiving control regimens These symptoms were severe in 20 of patients receiving EFV 600 mg daily and in 13 of patients receiving control regimens In clinical studies 21 of patients treated with 600 mg of EFV discontinued therapy because of nervous system symptoms
The majority of individuals who commence treatment for HIV in the UK start with a regimen that includes EFV in combination with other antiretrovirals These regimens are convenient once daily dosing and highly efficacious However EFV has several potential drawbacks including continued CNS toxicity the potential for teratogenesis and a low barrier to the development of virological resistance
Clinically controlled trials frequently reported undesirable nervous system side effects in patients receiving 600 mg EFV with other antiretroviral agents including dizziness insomnia somnolence impaired concentration and abnormal dreaming CNS symptoms of moderate to severe intensity were experienced by 194 of patients compared to 90 of patients receiving control regimens These symptoms were severe in 20 of patients receiving EFV 600 mg daily and in 13 of patients receiving control regimens In clinical studies 21 of patients treated with 600 mg of EFV discontinued therapy because of nervous system symptoms
Clinically controlled trials frequently reported undesirable nervous system side effects in patients receiving 600 mg EFV with other antiretroviral agents including dizziness insomnia somnolence impaired concentration and abnormal dreaming CNS symptoms of moderate to severe intensity were experienced by 194 of patients compared to 90 of patients receiving control regimens These symptoms were severe in 20 of patients receiving EFV 600 mg daily and in 13 of patients receiving control regimens In clinical studies 21 of patients treated with 600 mg of EFV discontinued therapy because of nervous system symptoms
The majority of individuals who commence treatment for HIV in the UK start with a regimen that includes EFV in combination with other antiretrovirals These regimens are convenient once daily dosing and highly efficacious However EFV has several potential drawbacks including continued CNS toxicity the potential for teratogenesis and a low barrier to the development of virological resistance
Clinically controlled trials frequently reported undesirable nervous system side effects in patients receiving 600 mg EFV with other antiretroviral agents including dizziness insomnia somnolence impaired concentration and abnormal dreaming CNS symptoms of moderate to severe intensity were experienced by 194 of patients compared to 90 of patients receiving control regimens These symptoms were severe in 20 of patients receiving EFV 600 mg daily and in 13 of patients receiving control regimens In clinical studies 21 of patients treated with 600 mg of EFV discontinued therapy because of nervous system symptoms
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