Atripla to Raltegravir Switch Study for CNS Toxicity
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
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
Truvada/raltegravir.
Phase:
Phase 3
Details
Lead Sponsor:
St Stephens Aids Trust
Treatments:
Efavirenz Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Raltegravir Potassium Tenofovir