HIV Infection Clinical Trial
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
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
Truvada/raltegravir.
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 19.4% of patients compared to 9.0% of patients
receiving control regimens. These symptoms were severe in 2.0% of patients receiving EFV 600
mg daily and in 1.3% of patients receiving control regimens. In clinical studies 2.1% 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 19.4% of patients compared to 9.0% of patients
receiving control regimens. These symptoms were severe in 2.0% of patients receiving EFV 600
mg daily and in 1.3% of patients receiving control regimens. In clinical studies 2.1% of
patients treated with 600 mg of EFV discontinued therapy because of nervous system symptoms.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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