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TMC125 Expanded access programme

Early access of TMC125 in combination with other antiretrovirals in treatment-experienced HIV-1 infected subjects with limited treatment options (TMC125-C214) This...
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Early access of TMC125 in combination with other antiretrovirals in treatment-experienced HIV-1 infected subjects with limited treatment options (TMC125-C214)

This trial is also listed on Clinicaltrials.gov

Update:This treatment has now been approved for sale to the public.

About the study

The purpose of this study is to provide early access to TMC125 for HIV-1 infected patients who have been on multiple failing antiretroviral (ARV) regimens and have limited treatment options with currently approved ARVs. Information on safety and tolerability aspects of TMC125 in combination with other ARVs in treatment-experienced HIV-1 patients with limited treatment options will be assessed. Available data regarding the effectiveness of the drug will also be collected.

All participants will receive TMC125 in the form of two 100 mg tablets to be taken orally following a meal every 12 hours. TMC125 will be administered in combination with an investigator-selected background of additional ARVs from the list of allowed medications. Study treatment will be continued until virologic failure, treatment-limiting toxicity, patient lost to follow-up, withdrawal, or pregnancy.

TMC125 will be provided via the expanded access program until discontinuation of TMC125 development or when TMC125 becomes commercially available in Canada.

About the treatment/intervention

TMC125 is an experimental non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed by Tibotec.

 

Eligibility criteria

Required

  • Patient is at least 3-class experienced (3 classes of licensed oral antiretrovirals: nucleoside/tide reverse transcriptase inhibitors [N[t]RTI], protease inhibitors [PI], non-nucleoside reverse transcriptase inhibitors [NNRTI])
  • Patients with primary NNRTI resistance can be included if they are experienced with at least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria Patient has previously received 2 different PI-based regimens
  • Patient is unable to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance
  • Patient, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen

Exclusion

  • Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216)
  • Use of disallowed concomitant therapy, including disallowed antiretrovirals (ARV)
  • Use of investigational ARVs (with exceptions)
  • Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the screening phase
  • Pregnant or breast-feeding female
  • Female patient of childbearing potential not using effective non-hormonal birth control methods
  • Patients with specific laboratory abnormalities
  • Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation

Note: Other criteria may apply.

Participating sites

If you are interested in taking part in this trial, speak to your doctor or contact the following study site directly:

Alberta

Southern Alberta HIV Clinic, Calgary, AB
Dr. John Gill
403-234-2399

University of Alberta Hospital, Edmonton, AB
Dr. Stephen Shafran
780-4007-8077

British Columbia

St. Paul’s Hospital, Vancouver, BC
Dr. Julio Montaner
604-806-8036

Downtown IDC, Vancouver, BC
Dr. Brian Conway
604-642-6429

Manitoba

Heath Sciences Centre, Winnipeg, MB
Dr. Ken Kasper
204-787-1624

Ontario

Ottawa General Hospital – General Campus, Ottawa, ON
Dr. Jonathan Angel
613-737-8442

University of Ottawa Health Services, Ottawa, ON
Dr. Donald Kilby
613-564-3950

Hamilton Health Sciences Centre, Hamilton, ON
Dr. Fiona Smaill
905-521-9800 ext. 76307

Sunnybrook, Toronto, ON
Dr. Anita Rachlis
416-480-4689

Maple Leaf Medical Clinic, Toronto, ON
Dr. Mona Loutfy
416-465-0856

Danforth Clinic, Toronto, ON
Dr. Gary Rubin
416-463-6829

Toronto General Hospital, Toronto, ON
Dr. Sharon Walmsley
416-340-5077

St. Clair Medical Association, Toronto, ON
Dr. Ken Logue
416-966-0178

Positive Care Clinic/Lakeridge Health, Whitby, ON
Dr. Michael Silverman
905-686-3900

St. Michael’s Hospital, Toronto, ON
Dr. Kevin Gough
416-864-6060 ext. 5668

Tsang Medicine Medical Corporation, Toronto, ON
Dr. Albert Tsang
416-928-2220

Windsor Regional Hospital – Metropolitan Campus, Windsor, ON
Dr. Corinna Quan
519-254-6115

Lawson Health Research Institute, London, ON
Dr. Edward Ralph
519-646-6207

Kingston General Hospital, Kingston, ON
Dr. Wendy Wobeser
613-533-2978

Quebec

Montreal General Hospital, Montreal, QC
Dr. Chris Tsoukas
514-934-8035

Montreal Chest/Royal-Victoria, Montreal, QC
Dr. Norbert Gilmore
514-934-1934 ext. 32144

Clinique Médicale l’Actuel, Montreal, QC
Dr. Benoît Trottier
514-524-1001

Clinique du Quartier Latin, Montreal, QC
Dr. Patrice Junod
514-285-5500

CHUM – Notre-Dame Hospital, Montreal, QC
Dr. Danielle Rouleau
514-890-8000 ext. 24720

Centre hospitalier de Québec-Pavillon CHUL, Ste. Foy, QC
Dr. Sylvie Trottier
418-654-2705

New Brunswick

Moncton Hospital, Moncton, NB
Dr. Gordon Dow
506-857-5670

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