HIV Clinical Trial
Official title:
A Phase IV Open-label, Multi-centre, Randomised, Dual-arm, Pilot Study to Assess the Feasibility of Switching Individuals Receiving Efavirenz With Continuing Central Nervous System (CNS) Toxicity, to Dolutegravir
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).
The main aim of this study is to investigate the benefits of switching from Efavirenz (taken
in combination with Kivexa®or as part of the combination pill, Atripla®) in patients with
Central Nervous System (CNS) side effects (such as difficulty with sleeping, bad dreams
etc). The study aims to investigate the effect of switching Efavirenz to Dolutegravir while
continuing Truvada (tenofovir plus emtricitabine, two constituents of Atripla) or Kivexa.
Dolutegravir will be the only new component of the combination.
In addition to the aims stated above, the study also aims:
To investigate whether switching to dolutegravir based combination Antiretroviral Therapy
(cART) is associated with resolution of CNS toxicity (determined by CNS questionnaire) at 12
weeks post switch To investigate continued virological suppression at levels of <400 and <50
copies/ml in individuals switching to dolutegravircontaining cART at 4 and 12 weeks post
switch To investigate changes in cluster of differentiation 4+ (CD4+) cell count in
individuals switching to dolutegravircontaining cART over 12 weeks post switch To
investigate the safety (laboratory and non CNS adverse events) of switching to dolutegravir
based cART over 12 weeks post switch To investigate changes in quality of life in
individuals switching to dolutegravir based cART as assessed by Quality of life (EuroQOL)
questionnaires over 12 weeks post switch To investigate the impact of switching to
dolutegravir based CART on anxiety and depression (as determined by Hospital Anxiety and
Depression Score (HADS) over 12 weeks post switch To investigate changes in quality of sleep
in individuals switching to dolutegravir based cART as per standardized sleep questionnaire
at 4 and 12 weeks post switch To assess the impact of switching to dolutegravir based cART
on adherence by standard questionnaire over 12 weeks post switch To investigate changes in
neuropsychiatric function in individuals switching to dolutegravir based cART by CogState
battery and Instrumental Activities of Daily Life (IADL) questionnaire over 12 weeks post
switch To investigate changes in fasting cholesterol and triglycerides in individuals
switching to dolutegravir based cART over 12 weekspost switch To investigate Efavirenz (EFV)
plasma decay and its impact on Dolutegravir (DTG) concentrations following the switch
(Maximum Concentration (Cmax), Minimum Concentration (Cmin), Area Under the
concentration-time Curve (AUC) at weeks 1, 2 and 3 post switch) To investigate the
association between genetic polymorphisms in drug disposition genes and drug exposure To
assess changes in the levels of tryptophan, kynurenine, kynurenine/tryptophan ratio,
neopterin, tumour necrosis factorα and interferonγ in plasma following treatment switch from
efavirenz to dolutegravir.
To investigate the relationship between the immune activation biomarkers and the
kynurenine/tryptophan ratio at baseline and post switch.
To investigate the relationship between the kynurenine/tryptophan ratio and measures of CNS
toxicity and neurocognitive impairment at baseline and postswitch.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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