Efavirenz to Dolutegravir Switch in Patients With CNS Toxicity
Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
This is a phase IV, open label, multicentre trial that will be taking place at 4 sites in the
United Kingdom (UK). Efavirenz which is taken in combination with Kivexa® or as part of the
combination pill, Atripla® is a recommended firstline regimen for the treatment of Human
Immunodeficiency Virus-1 (HIV- 1) infection. Treatment against the HIV virus is also referred
to as antiretroviral therapy.
Toxicity is the most common reason for modification of firstline therapy. Central Nervous
System (CNS) side effects such as difficulty with sleeping & bad dreams are common side
effect of Efavirenz based therapy and is one of the most frequent reasons for switching or
discontinuing highly active antiretroviral therapy.
Dolutegravir is within a novel class of antiretroviral agents licensed in the UK for the
treatment of HIV. In combination with Truvada®, it showed fewer side effects when compared to
Efavirenz in other clinical studies, where patients were starting HIV treatment for the first
time, or switching from other agents.
The purpose of the study is to investigate the benefits of switching away from Eefavirenz (in
combination with Kivexa® or as part of the combination pill, Atripla®) to Dolutegravir in
patients with CNS side effects (such as difficulty with sleeping, bad dreams etc).
Phase:
Phase 4
Details
Lead Sponsor:
St Stephens Aids Trust
Collaborator:
ViiV Healthcare
Treatments:
Dolutegravir Efavirenz Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Tenofovir