Status:
UNKNOWN
Efavirenz to Dolutegravir Switch in Patients With CNS Toxicity
Lead Sponsor:
St Stephens Aids Trust
Collaborating Sponsors:
ViiV Healthcare
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 pi...
Detailed Description
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 S...
Eligibility Criteria
Inclusion
- Is male or female aged 18 years or older
- Has HIV-1 infection documented in their medical notes
- Has signed the Informed Consent Form voluntarily
- Is willing to comply with the protocol requirements
- Is currently on an antiretroviral regimen comprising at least three licensed antiretroviral agents one of which is EFV, for at least 12 weeks
- No previous exposure to integrase inhibitors
- Has an HIV-plasma viral load at screening \<400 copies/mL (single re-test allowed)
- Has a CD4 cell count at screening \>50 cells/mm3
- Estimated glomerular filtration rate (MDRD) \>50 ml/min.
- Has symptomatic CNS related toxicity associated with EFV at least Grade 2 by ACTG criteria
- If female and of childbearing potential, is using effective birth control methods (as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 30 days after the end of the trial.
Exclusion
- Infected with HIV-2
- Using any concomitant therapy disallowed as per SPC for the study drugs
- Has acute viral hepatitis including, but not limited to, A, B, or C
- Subjects positive for Hepatitis B at screening (+HBsAg), or anticipated need for Hepatitis C virus (HCV) therapy during the study
- Alanine aminotransferase (ALT) greater than or equal to 5 times the upper limit of normal (ULN), OR ALT greater than or equal to 3xULN and bilirubin greater than or equal to 1.5xULN (with \>35% direct bilirubin)
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Any investigational drug within 30 days prior to the trial drug administration
- Has received dolutegravir in the past
- Any clinical evidence of baseline resistance mutations
- History or presence of allergy to DTG or excipients (D-Mannitol, Microcystalline Cellulose, Povidone, Croscarmellose Sodium, Sodium Stearyl Fumarate, Talc, white film coat)
- Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification
- Moderate or severe renal impairment (creatinine clearance \< 50ml/min by Cockroft-Gault method)
- If female, she is pregnant or breastfeeding
- Screening blood result with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed).
- Any condition (including drug/alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the trial.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02285374
Start Date
November 1 2014
End Date
December 1 2015
Last Update
November 7 2014
Active Locations (1)
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1
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9TH