MINUTES
CO-INFECTIONS AND CONCURRENT DISEASES CORE
Monday, October 22, 2012 – 2:00 P.M. to 4:30 P.M.
MARRIOTT BLOOR YORKVILLE HOTEL – Forest Hill Ballroom
90 Bloor Street East, Toronto, ON M4W 1A7
Summary of Action Items
Guidelines
Action Item
Follow-up
Communicate with Mark Hull re: co-infection guidelines, expedite completion
M. Klein & C. Cooper
Open Discussion
Action Item
Follow-up
Develop concept of probiotics and influence on liver fibrosis progression
C. Cooper &
W. Woebser
Increased insulin resistence is associated with accellerated liver fibrosis
progression and reduced HCV antiviral therapy response. Metformin may perturb
HCV replication and protect the liver from fibrosis progression while HIV-HCV coinfected patients await improved HCV therapies. Serial Fibroscan, Fibrotest,
APRI, etc can be used to monitor liver fibrosis. To develop concept further.
Explore collaborative studies with the VACS as they have large well defiend HIVand HIV+ HCV populations that are untreated for HCV and interest in risk factor
modification is high. Marina will raise at next VACS liver group meeting
C. Cooper &
M. Doyle
M. Klein
1) Rapid Fire Updates on Current Studies and Projects
Pilots
CTNPT 011 – Penicillin therapeutic drug monitoring in the treatment of infectious syphilis
Paul MacPherson
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Slow recruitment, 2 sites, 5-6 patients, very few syphilis cases in past year in Ottawa
Toronto is contributing
Vancouver finalizing contracts;
Montreal is initiating REB and contracts
CTNPT 014 –An observational study of Kaletra/Celsentri combination therapy for the management
of HIV infection in the setting of HCV co-infection
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Nucleoside free regiments
Darunavir and raltegravir have unexpectedly high failure rate (US study)
MODERN trial is looking up the regimen
Kaletra and Maraviroc is being explored
Goal of 40 patients; have 1 patient on treatment, 3 patients being screened
Open to other site involvement
Brian Conway
MINUTES
CTNPT 005 – Measuring Cognitive decline in patients at high risk for developing HIV-related
neurocognitive disorders
 Recruiting patients, 5-6 enrolled
Start-Ups
CTN 260 – Raltegrevir SWITCH Study
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Marina Klein
Try to prevent progression of fibrosis
Trying to recruit 40 patients, 20 protease inhibitor, 20 on raltegravir
Currently enrolling; 2 enrolled, 4 in screening, a few pre-screened
4 sites at various stages, Vancouver; Toronto, Vancouver St Paul’s – almost ready for
recruitment; Ottawa about to go to REB
Enrolling
CTN 222 – Canadian Co-infection Cohort Study
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Marina Klein
2 new sites – Quebec City (15 pts), Saskatoon ready to recruit
17% LTFU, 121 deaths
Fibroscan sub-study: 3 sites participating, open to new sites
Inflammatory biomarkers: samples ready for analysis
Food security sub-study: encourage all sites to participate
Community based primary healthcare team grant – 3 cores Indigenous, Addiction, Linking
Primary and Tertiary care
CTN 236 – HPV vaccine in HIV-positive girls and women
 396 recruited of 500 targeted
 112 have serologic data
 To have a planning meeting in November about next steps re: funding and analyses on
specimens collected
Reporting
CTN 194 – Peg-interferon and citalopram in co-infection (PICCO)
Marina Klein
 24 week results presented at IAS
 Ongoing analyses (48 week) will be drafted as manuscript
 Secondary analyses ongoing
CTN 273 / 253 – H1N1 flu vaccine study in HIV-positive adults
Curtis Cooper
 Primary outcome papers are published
 Working on some lab based analyses continues
Guidelines – HIV-HCV Co-Infection Guidelines
Curtis Cooper
 Mark Hull is leading, will circulate for feedback
 Time sensitive as BHIVA is preparing similar guidelines
 ACTION: Marina to communicate with Mark Hull. Curtis willing to assist to expedite completion.
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MINUTES
 ACTION: Marina is editing a complementary slide kit as well
Other CCD Members
Louise Balfour:
 CANQuit- quit smoking trial
 RCT, REB approval in Ottawa
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Bertrand Lebouché:
BOC/Telaprevir symptoms study
Compare symptom experience
Describe experience of symptoms and describe experience of the treatment strategy
Secondary objectives: quality of life, depression, productivity,
Observational multicentre study between France and Montreal, mixed methods
Pharma funded, investigator driven study (special permission)
Suggested that CTN datacentre might help with help advise re:appropriate sample size vs.
feasibility issues
2) Session # 1 – Endocrine Disease in HIV and HCV
 Mary-Ann Doyle – Overview (20 minutes)
 Group Feedback and Discussion
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High insulin levels may be related to hepatic steatosis, hepatocellular carcinoma, etc.
IL28 may have higher risk of insulin resistance, independent predictor of SVR
May need to recruit internationally to have access to GT1 patients not on a DAAs
Study looking at metformin showed improvement in women, but limitations to study
3) Session # 2- HIV-HCV Cohort Research
 Registry Development / linkage with CTN 222 cohort data – Marina Klein
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Use infrastructure and collect co-infection and HCV mono data
DAA data capturing, retrospective and prospective data collection
No HCV mono-infection dataset exists in Canada
How to increase access to treatment, potential interventions
Increasing use of ID specialists and hepatologists taking care of HCV patients
Expanding scope of research and interventions in CTN to include mono-infection;
potential future avenue and means of having good HIV negative control copmparision
groups
Have received suggestions re: case report form. Marina will revise and re-cirulate, try
piloting within the CCC and we will explore engaging HCV mono-infected GI treaters.
Issue will be funding—pharma vs. not.
[3]
MINUTES
4) Session # 3- Idea Generation Open Discussion
This was modified to Breakout Sessions:
Group 1
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Treating HCV mono-infection as HIV prevention, especially in injection drug users- Brian Conway
lead this discussion
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Threat to HCV treatment access is limited/no funding
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Probiotics and influence on liver fibrosis progression has many potential benefits and few risks. A
study could be relatively inexperensive to conduct and easy to recruit for. There was community
member / patient buy-in during the discussion as they recognize better patient willingness for
alternative treatments. Cross contamination of study arms a potential issue.
ACTION: Cooper to consider further developing this concept. Wendy Woebser expressed interest
as well.
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Increased insulin resistence is associated with accellerated liver fibrosis progression and reduced
HCV antiviral therapy response. Metformin may perturb HCV replication and protect the liver from
fibrosis progression while HIV-HCV co-infected patients await improved HCV therapies. Serial
Fibroscan, Fibrotest, APRI, etc can be used to monitor liver fibrosis.
ACTION: Cooper & Doyle will develop this concept further; possibility of exploring collaborative
studies of this strategy type with the VACS as they have large well defiend HIV- and HIV+ HCV
populations that are untreated for HCV and interest in risk factor modification is high. Marina will
raise at next VACS liver group meeting
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Optimization of care
Group 2
Drs Balfour/MacPherson/Smieja- CIHR funded; HIV Canquit smoking RCT Breakout session
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The study protocol was submitted to the main Ottawa study site OHRI REB
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The study received REB approval contingent on obtaining a “letter of No Objection” from Health
Canada. Health Canada submission will occue in the next 2 weeks.
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Interested HIV clinics sites were provided with more information about the study and wih the CTN
Site Investigator Confirmation of Participation Forms. To date, 7 sites across Canada have
expressed interest in participating including HIV clinic sites in Halifax, Montreal, Ottawa, Toronto,
Hamilton, London, Sudbury and Vancouver. The CTN site investigator forms were sent to the
CTN.
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Next steps include assisting the sites with obtaining REB approval and working on study
contracts.
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MINUTES
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Study sites will need to identify the smoking cessation counselor(s) at each site (e.g. study nurse
interested in learning smoking cessation intervention, HIV clinic staff such as pharmacists, social
workers) who will be provided with a 1 day training workshop in the smoking cessation
intervention manual conducted by Dr Louise Balfour and her team (e.g., Dr Crystal Holly HIV
Clinical Health Psychology post-doctoral fellow). Follow-up telephone supervision/training on the
smoking cessation training intervention manual will also be provided.
5) Attendance
Anis, Aslam
Balfour, Louise
Benoit, Anita
Bernard, Nicole
Latendre-Paquette, Judy
Lebouché, Bertrand
Loranger, Larry
Masching, Renée
Blitz, Sandra
Brophy, Jason
Clarke, Michael
Collins, Evan
Conway, Brian
McLean, Robert
Mesplède, Thibault
Cooper, Curtis
Costiniuk, Cecilia
Cox, David
DeAbreu, Ian
Doyle, Mary-Ann
Finney, Constance
Godin, Guy-Henri
Grennan, Troy
Murray, Mélanie
Osborne, Chuck
Pankovich, Jim
Peltier, Doris
Pendergraft, Kevin
Puri, Laura
Jones, Michelle
Kang, Chil-Yong
Kaul- Rupert
Raboud, Janet
Routy, Jean-Pierre
Schechter, Martin
Science, Michelle
Segatto, Bianca
Singer, Joel
Smaill, Fiona
Smieja, Marek
Sousa, José
Spaans, Johanna
Tan, Darrell
Tremblay, Cecile
Klein, Marina
Walmsley, Sharon
Haase, David
Harris, Marianne
Hart, Trevor
Jenabian, Ali
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