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

Phase 1

• Conditions: HIV infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-003704-39-IT
• Lead Sponsor: St Stephen's AIDS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-28
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

1.Is male or female aged over 50, OR aged over 18 years with a Framingham risk score above 10%
2.Has documented HIV-1 infection
3.Has signed the Informed Consent Form voluntarily
4.Is willing to comply with the protocol requirements
5.Has been receiving an ARV regimen containing a boosted PI (darunavir, atazanavir, lopinavir, saquinavir, or fosamprenavir) plus 2NRTIs for >24 weeks
6.Has stable virological suppression (plasma HIV-RNA <50 copies/mL for >24 weeks)
7.If female and of childbearing potential, is using effective birth control methods (see appendix 4) and is willing to continue practising these birth control methods during the trial and for at least 2 weeks after the last dose of study medication. Note: Non-childbearing potential is defined as either post-menopausal (12 months of spontaneous amenorrhoea and =45 years) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy
8.If a heterosexually active male, he is using effective birth control methods and is willing to continue practising these birth control methods during the trial and until follow-up visit

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

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.Any prior evidence of primary viral resistance (if a resistance test is available) based on the presence of any major resistance-associated mutation to backbone NRTI
7.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 (NOTE: Switch for toxicity or tolerability with wild type virus does not count as virological failure)
8.Dialysis or renal insufficiency (creatinine clearance < 50ml/min)
9.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.
10.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))
11.Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification (see appendix 5)
12.If female, currently pregnant or breastfeeding
13.Opportunistic infection within 4 weeks prior to first dose of DTG
14.Clinical decision that a switch of antiretroviral therapy should be immediate
15.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).
16.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.
17.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