CV risk in HIV patients switching from a boosted PI to DTG

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 420

Inclusion Criteria

HIV-infected individuals on PI/r plus 2 NRTIs, with a viral load <50 copies/mL for >24 weeks, aged >50 years OR >18 years with a Framingham CVS risk score above 10%
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1.Infected with HIV-2
2.Using any concomitant therapy disallowed as per the reference safety information and product labelling for the study drugs
3.Has acute viral hepatitis including, but not limited to, A, B, or C
4.Has chronic hepatitis B and/or C with AST and/or ALT >5 x ULN
Note: Subjects can enter trial with chronic HBV if HBV-DNA undetectable at screen (and no detectable result in last 6 months) and with chronic HCV if not expected to require treatment during the trial period.
5.Any investigational drug within 30 days prior to the trial drug administration
6.History of exposure to any ARVs other than PIs or NRTIs except if switch was for tolerability/toxicity (NOTE: patients who have previously taken part in single drug trials for less than 14 days need not be excluded, or for virological failure with a genotypic resistance test without mutations
7.Any prior evidence of primary viral resistance based on the presence of any major resistance-associated mutation to backbone NRTI
8.History of prior virological failure,eg 2 consecutive HIV-1 RNA >50 c/ml -at or after week 32 following first ART initiation or confirmed rebound viraemia >200 copies/ml after having a VL of <50 copies/ml without resistance test or with significant mutations to any other ARV regimen (NOTE: Switch for toxicity or tolerability with wild type virus does not count as virological failure)
9.Dialysis or renal insufficiency (creatinine clearance < 50ml/min)
10.History of decompensated liver disease (AST or ALT=5x the upper limit of normal (ULN) or ALT = )3 x ULN and bilirubin = 1.5 x ULN with > 35% direct bilirubin.
11.Unstable liver disease (as defined by the presence of ascities, encephalopathy, coagulopathy, hypoalbuminemia, esophagael or gastic varices, or persistent jaundice), know biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones))
12.Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification (see appendix 5)
13.If female, currently pregnant or breastfeeding
14.Opportunistic infection within 4 weeks prior to first dose of DTG
15.Clinical decision that a switch of antiretroviral therapy should be immediate
16.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).
17.Any condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the trial.
18.History or presence of allergy to the study drug or their components

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

CV risk in HIV patients switching from a boosted PI to DTG

Recruitment & Eligibility

Study & Design

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