DR. GERVAIS FRÉCHETTE CURRICULUM VITAE

Dr. Fréchette’s CV

EDUCATION

1981-1986
University Of Montreal Quebec, Canada; Doctorate in Medicine LMCC, Canadian Boards of Medicine

1986-1987
Internship, St-Luc Hospital, University of Montreal

1987-
License from the College of Physicians to practice Medicine; Quebec, Canada

1999-
License from the University of the State of New York to practice Medicine and Surgery in the State of New York, USA

2002-
Certification from the American Academy of HIV Medicine (AAHIVM)

2004-
License from the Medical Board of the State of California to practice Medicine and Surgery in the State of California, USA

2007-
Certificate from the International Society of Cosmetogynecology to perform lipoplasty in the State of New York, USA. Certifies intensive didactic and hands-on intraoperative training in every aspect of tumescent liposuction surgery including perioperative evaluation and care, the clinical pharmacology of tumescent liposuction medications, safe surgical techniques, safe power-assisted liposuction technologies, and the prevention and management of potential complications.

2007-
Certificate from the Berkowits School licensed by New York State Education Department. Certifies satisfactorily completed the prescribed course of forty hours of training in Laser Hair Removal.

Practicing Medicine since 1987:

Primary Care

• Member of the University of Montreal, Faculty of Medicine University Hospital 1987-2000
• Member of St-Luc Hospital Emergency Room Department of General Medicine 1987-1994
• Director of a Center for Inoculation and Adviser for International Travelers St-Luc Hospital Montreal, Canada 1987-1994
• Private Consultant in the Health Department of St-Luc Hospital, AIDS and STD Montreal, Canada 1987-1996
• Private Practice composed of Research, Diagnosis, Treatment and Follow-up of people living with HIV Montreal, Canada 1987-1996
• Research, working in New York City in a private practice with HIV+ patients New York, USA 1996-2000
• Private Practice composed of Research, Diagnosis, Treatment and Follow-up of people living with HIV New York, USA 2000-
• Private Practice composed of Research, Diagnosis, Treatment and Follow-up of people living with HIV San Francisco, USA 2004-

Clinical Research: 1987-

• Co-Investigator, Zidovudine (AZT) Monotherapy trial with HIV+ Patients Burroughs Wellcome 1987-1989
• Co-Investigator, Videx (DDI) Monotherapy trial with HIV+ Patients Bristol-Myers Squibb 1989-1991
• Co-Investigator, HIVID (DDC) Monotherapy trial with HIV+ Patients Hoffman LaRoche 1991-1992
• Co-Investigator, Phase III study of Zidovudine (AZT) with two levels of Intron A in the treatment of AIDS elated Kaposi Sarcoma Schering 1992-1995
• Principal Investigator, 42810-083: A Randomized, double blind, double-dummy multi-center Acyclovir controlled study to assess the safety and the security and efficacy of oral Famcyclovir in HIV+ patients with recurrent herpes simplex infection SmithKline Beecham 1993-1995
• Principal Investigator, a double-blind comparison of Itraconazole oral solution and Fluconazole capsules for the treatment of Oral Candidaisis in AIDS patients Janssen 1993-1994
• Principal Investigator, NV 14256: A Randomized, double blind, multi-center, parallel study of Ro 31-8959 (protease inhibitor) alone, Hivid (DDC) alone and both in combination at two different dose levels of Ro 31-8959, a treatment for advanced HIV infection (CD4 50-300 cell/mm3) in patients discontinuing or unable to use Zidovudine (AZT) Hoffman La Roche 1994-1996
• Principal Investigator, ITR-INT 49: Primary prophylaxis of fungal infections in HIV+ patients with Itraconazole capsules. A double-blind placebo-controlled study Janssen 1994-1996
• Principal Investigator, P115-2113: A randomized, open-label trial of high dose Atovaquone Vs Aerosolized Pentamidine for prophylaxis of Pneumocystis carini Pneumonia in patients with HIV infection who are intolerant of TMP-SMX GlaxoWellcome 1994-1996
• Principal Investigator, SV 14788C: A continuation protocol with open label Saquinavir for HIV+ patients who have completed a clinical trial with Saquinavir (Ro-31-8959) treatment Hoffman La Roche 1994-1996
• Principal Investigator, NUCB 3007 (525/140): A clinical trial to compare the efficacy and safety of 3TC + Loviride versus placebo in the treatment of HIV+ patient taking concurrent AZT-containing treatment regimen with CD$ counts between 25-250 cells/mm3 The Caesar Study GlaxoWellcome 1995-1996
• Principal Investigator, 901-OC: A non-comparative, multi-national, open-label, 48 weeks study to monitor the safety and tolerability of MK-639 (Indinavir Sulfate) 800mg q 8 hours administered as Monotherapy in combination with reverse transcriptase inhibitor for the treatment of advanced HIV-1 infection Merck Frost 1995-1996
• Co-Investigator, Protocol UMD 95-009 Open-label Compassionate Use of Nitazoxanide for the treatment of Cryptosporidiosis in AIDS patients UNIMED Galagen 1996-1997
• Co-Investigator, A multi-center, Randomized, double-blind, parallel-Group Placebo-Controlled, Phase II Study of the Safety and Efficacy of Bovine Immunoglobulin Concentrate-c PARVUM IN THE TREATMENT OF DIARRHEA ASSOCIATED WITH Cryptosporidium vum infection in Adult patients with AIDS Galagen 1996-1997
• Co-Investigator, A Phase II, open-label multi-center study DMP-266-024 to Characterize the effectiveness, safety, and pharmacokinetics of Nelfinavir in combination with DMP-266 in antiretroviral therapy naïve or nucleoside analogue experienced HIV-infected Patients Dupont Pharmaceuticals 1996-1998
• Co-Investigator, A randomized Phase IIIB Comparative Study to evaluate Saquinavir Soft Gel Capsules (SGC) TID Regimen in combination with two NRTIs versus Saquinavir Soft Gel Capsule (SGC) BID plus Nelfinavir BID plus a NRTI in HIV-infected Patients Roche 1997-1999
• Co-Investigator, A randomized, open-label study to compare the effect of Procrit (Erytropoeitin Alfa) three times weekly versus Once weekly in treatment of anemia, on the quality of life of HIV-infected patients Ortho-Biotech 1997-2000
• Co-Investigator, Sustiva (DMP-266) Expanded Access Program for the treatment of HIV+ patients who are either failing therapy or intolerant of their current HIV regimen and who have a CD4 cell count < 50 cells/mm3 Dupont Pharmaceuticals 1997-1998
• Co-Investigator, CNAA/B3008, A 1582U89 Open-label for Adult patients with HIV-1 Infection GlaxoWellcome 1997-1999
• Co-Investigator, Adefovir Dipivoxil, expanded access Program for the treatment of HIV+ patients who are either failing therapy or intolerant of their current HIV drug regimen and who have a CD4 cell count <50 cells/mm3 Gilead 1997-2000
• Co-Investigator, Vira 3001, An open-label randomized trial comparing the effect on viral load of standard HIV treatment practice (delayed phenotyping) with treatment based on Antivirogram (immediate phenotyping) GlaxoWellcome 1998-1999
• Co-Investigator, Amprenavir (141W94) an open-label protocol for subjects with HIV-1 infection who have experienced treatment failure or are intolerant to previous protease inhibitor therapy, protocol PRO30010 GlaxoWellcome 1999
• Co-Investigator, A phase IV, open-label, randomized, multi-center study to determine the safety and duration of viral suppression of continued therapy with one or two protease inhibitors + two nucleoside analogue reverse transcriptase inhibitor regimen versus substitution therapy with Efavirenz + the same two nucleoside analogue reverse transcriptase inhibitors in HIV+ patients, DMP-266-049 Dupont Pharmaceuticals 1999-2000
• Co-Investigator, A randomized, double-blind, phase III study of ABT-378/ritonavir plus Stavudine and lamivudine Vs Nelfinavir plus Stavudine and Lamivudine in antiretroviral-naïve subjects, protocol M98-863 Abbott 1999-2000
• Co-Investigator, A randomized, open-label, phase III Study of ABT-378/ritonavir in combination with Nevirapine and two nucleoside analogue reverse transcriptase inhibitors (NRTIs) Vs Investigator selected protease inhibitors in combination with Nevirapine and two NRTIs in Antiretroviral-Experienced HIV+ subjects, protocol M98-888 Abbott 1999
• Co-Investigator, A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Adefovir dipivoxil as intensification therapy in combination with Highly Active Anti-Retroviral Therapy (HAART) in HIV+ patients with HIV-RNA>50 and <400 copies per mL, protocol GS-97-415 Gilead 1999
• Co-Investigator, A phase III trial to determine the efficacy of Bivalent AIDSVAXtm B/B vaccine in adults at risks of sexually transmitted HIV-1 infections in North America and Europe, protocol VAX 004 Vaxgen 1999-2000
• Co-Investigator, A randomized, double blind, adjuvant-controlled, multi-center, phase III study to compare the virologic and immunologic effect of Highly Active Antiretroviral Therapy (HAART) plus Remmune Versus HAART plus incomplete freund’s adjuvant (IFA) in Antiretroviral naïve patients infected with HIV-1 Agouron 1999-2000
• Co-Investigator, A phase II, open-label, randomized study of the efficacy and safety of Epivir 150 mg BID versus 300mg once daily when administered for 24 weeks in combination with FDA approved dosage regimen of Zerit and either Crixivan or Viracept in subjects HIV+, Protocol Cola 4005 GlaxoWellcome 1999
• Co-Investigator, A randomized, multi-center, open-label trial to evaluate the reversibility of dyslipidemia upon substitution of Abacavir for a protease inhibitor in virologically controlled HIV+ subjects with elevated cholesterol, protocol 40003 GlaxoWellcome 1999
• Co-Investigator, GS-99-908, An open-label, multi-center, Compassionate access Study of the Safety of Tenofovir Disoproxil Fumarate Administered with other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients Gilead 1999-2000
• Co-Investigator, GS-99-907, A Phase III, double blind, Randomized, Placebo Controlled, Multi-center Study of the safety and efficacy of Tenofovir Disiproxil Fumarate (Tenofovir DF) in Combination with Other Antiretroviral Agents for the treatment of HIV-1 Infected Patients Gilead 1999-2000
• Co-Investigator, A Multi-center, Open-label 24 week study to evaluate the efficacy and safety of Indinavir Sulfate 800 mg and Ritonavir 200mg bid plus 2 NRTIs bid in HIV-1 Infected Individuals who require early treatment Intervention protocol 107 Merck 1999-2000
• Co-Investigator, NCI Cohort and Nested Case Control Study of AIDS-related Non-Hodgkin’s Lymphoma, Kaposi Sarcoma and other Malignancies National Cancer Institute and NIH 1999
• Co-Investigator, ABT378/ritonavir early access Program Abbott 1999-2000
• Principal Investigator, CS-L2-9901, A randomized controlled substudy of SILCAAT investigating the effect of IL-2 on vaccine responsiveness in HIV-infected patients immunized with Hepatitis A Vaccine, Pneumococcal Vaccine and dTCHIRON 1999-2000
• Principal Investigator, APV30001, A Phase III, randomized, multi-center, parallel, open-label study to compare the efficacy, safety and tolerability of GW433908 (1400 mg BID) vs Nelfinavir (1250mg) over 48 weeks in antiretroviral therapy naïve HIV-1 Infected Adults GlaxoSmithKline 2000-2004
• Principal Investigator, CS-L2-9901 A Phase III Multi-center Randomized Study of the Biological and Clinical Efficacy of Subcutaneous Recombinant, Human Interleukin-2 in HIV-Infected Patients with Low CD4+ Counts Under Active Antiretroviral Therapy, The SILCAAT Study Chiron-NIH 2000-
• Principal Investigator, CS-L2-9901M A Maintenance Protocol for Recombinant Human IL-2 in HIV-infected Patients Who have Completed or Reached a Primary Endpoint in SILCAAT Chiron 2000
• Principal Investigator, CS-MM-9901, A Bridging Dose-escalation Study of the Safety, Pharmacokinetic Properties, and Immunologic Effect of Subcutaneous L2-7001 (Recombinant Human Interleukin-2) in Patients Infected with HIV with CD4+ T-cell Counts of 300 to 500 cells/mm3 and Viral Burden Under 10,000 copies/mL on Active Anti retroviral Therapy ART Chiron 2000-2001
• Principal Investigator, Protocol 112-00/CRX497, A Multi-center, Open-Label Randomized Study to Compare the Efficacy and Safety of Indinavir 800mg b.i.d. Plus Ritonavir Plus Two NRTIs vs. Nelfinavir 1250mg b.i.d. Plus Two NRTIs in HIV-1 Seropositive Patients Who have Failed an NNRTI Containing Regimen Merck 2001-2002
• Principal Investigator, #22669, Amendment 1, A twelve week multi-center study comparing conventional needle injection of Serostim subcutaneously vs. subcutaneous injection of Serostim using a needle-free device. Serono 2001
• Principal Investigator, APV30003, A Phase III Randomized Multi-center Parallel Group Open Label Three Arm Study to Compare Efficacy and Safety of Two Dosing Regimens of GW433908/ritonavir (700mg/100mg twice daily or 1400mg/200mg once daily) versus lopinavir/ritonavir (400mg/100mg twice daily) for 48 weeks in Protease Inhibitor Experienced HIV Infected Adults Experiencing Virological Failure GlaxoSmithKline 2001-2004
• Principal Investigator, APV30005, An Open Label, Phase III study to assess the Long term Safety Profile of GW433908 Containing Regimens in HIV-I Infected Subjects Glaxo Smith Kline 2001-2006
• Principal Investigator, AI266406: Vest QD: A Phase IV Open Label Randomized Multi-center Study Switching HIV-! Infected Subjects with a Viral Load < 50 Copies/mL on a First PI Based Regimen to a Efavirenz Substitution Regimen Bristol Myers Squibb 2002-2004
• Principal Investigator, ZIP ESS30005 Amendment 1, A Phase IV, open-label, multi-center study of treatment with Trizivir (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) twice daily and Tenofovir 30 mg once daily for 48 weeks in HIV-infected subjects experiencing early virologic failure (ZIAGEN Intensification Protocol) Glaxo Smith Kline 2002
• Principal Investigator, REALISE Levitra, Real Life Safety and Efficacy of Levitra; BAY 38-9456 (vardenafil) Bayer 2003-2004
• Principal Investigator, ESS30009 (ELAATE), A Phase III, randomized, open-label, multi-center study of the safety and efficacy of Efavirenz vs. Tenofovir when administered in combination with the Abacavir/Lamivudine fixed-dose combination tablet as a once-daily regimen in antiretroviral-naïve HIV-I infected subjects. GlaxoSmithKline 2003
• Principal Investigator, ESS100732, A Phase IIIB, Open-Label Multi-center Study of the Safety of GW433908 (700mg) BID) plus ritonavir (100 mg BID) when Administered in Combination with the Abacavir/Lamivudine (600mg/300mg) Fixed Dose Combination Tablet QD in Antiretroviral-Naïve HIV-1 Infected Adults Over 48 Weeks Glaxo Smith Kline 2004-
• Principal Investigator, Protocol BMS AI424-128, A Phase IV, Multi-center, Cross-Sectional Study to Evaluate 150L Substitution among Subjects Experiencing Virologic Failure on a HAART Regimen Containing Atazanavir (ATV) Bristol Myers Squibb 2005-
• Principal Investigator, HPR20001, A Phase IIB Randomized, Multi-center, Parallel Group Study to Evaluate the Short-Term Safety, Pharmacokinetics and Antiviral Activity of Four Blinded Dosing Regimens of GW640385/Ritonavir Therapy Compared to Open-label Current Protease Inhibitor Therapy in HIV-1 Infected, Protease Inhibitor Experienced Adults for 2 weeks with Long-Term Evaluation (>48 weeks) of Safety, Pharmacokinetic and Antiviral Activity of Selected GW640385/Ritonavir Dosing Regimen(s) vs. a Ritonavir-boosted, Protease Inhibitor Containing Regimen GlaxoSmithKline 2005-2006
• Principal Investigator, APV30007, A 24 Week, Phase IIIB/IV, Single Arm, Open-Label Observational Study to Explore the Efficacy of Protease Inhibitors given in combination with Reverse Transcriptase Inhibitors to HIV-1 infected Subjects with Protease Mutations Selected During Treatment with GW433908 Containing Antiretroviral Therapy Glaxo Smith Kline 2005-
• Principal Investigator, ESS100290, A Phase IV Open Label Multi Center Trial to Evaluate the Safety Tolerability and Efficacy of HIV-I Infected Subjects. Switching Their Current Protease Inhibitor Therapies for a Fosamprenavir Therapy Over 48 Weeks GlaxoSmithKline 2005-
• Principal Investigator, DL6049-0417, An Open Label Registry Study of the Facial Lipoatrophy Correction Experience with SCULPTRA in Subject with Human Immunodeficiency Virus (FACES Study) Dermik 2005-
• Principal Investigator, A screening protocol to determine eligibility for one of three Phase III treatment studies evaluating the efficacy and safety of GW873140 in R5-tropic and R5/X4-tropic HIV-I infected, treatment experienced subjects with drug resistant virus or an observational study in X4-tropic or non-phenotypable HIV-I infected treatment experienced subjects with drug-resistant virus. GlaxoSmithKline 2005
• Principal Investigator, GS-US-164-0107, Combination of Efavirenz and Truvada (The COMET Study) A Phase 4 evaluation of switching from twice daily Zidovudine and Lamivudine (Combivir) to a simplified, once-daily, regimen of co-formulated Emtricitabine and Tenofovir Diproxil Fumarate (Truvada) in virologically suppressed HIV infected patients taking Efavirenz Gilead 2005
• Principal Investigator, AI424103, A Phase IIIb open-label, randomized, multi-center study comparing the antiviral efficacy, safety, and effect on serum lipids of Atazanavir/Ritonavir vs. Lopinavir/Ritonavir, each in combination with Tenofovir and either Didanosine EC or Stavudine XR I HIV-I infected subjects receiving a NNRTI-containing HAART regimen who are experiencing their first virologic failure Bristol Myers Squibb 2005-2006
• Principal Investigator, EPZ104057, a 96-week, Phase IV, randomized, double-blind, multi-center study of the safety and efficacy of EPZICOM vs. Truvada administered in combination with Kaletra in antiretroviral-naïve HIV-I infected subjects Glaxo Smith Kline 2005-2006
• Principal Investigator, CCR100136, A Phase IIb, 96 week, randomized, open-label, multi-center, parallel group, repeat dose study to evaluate the safety tolerability, pharmacokinetics and antiviral effect of different doses and regimens of GW873140 in combination with Kaletra (lopinavir and ritonavir) in HIV-I infected antiretroviral therapy naïve subjects GlaxoSmithKline 2005-2006
• Principal Investigator, STRIVE APR 20001, A Phase IIb, randomized, multi-center, parallel group study to evaluate the short-term safety, pharmacokinetics and antiviral activity of four blinded dosing regimens of GW640385/Ritonavir therapy compared to open-label current protease inhibitor therapy in HIV-I infected, protease inhibitor experienced adults for 2 weeks with long-term evaluation (> 48 weeks) of safety, pharmacokinetic and antiviral activity of selected GW640385/Ritonavir dosing regimen(s) vs. a Ritonavir-boosted, protease inhibitor containing regimen Glaxo Smith Kline 2006
• Principal Investigator, ABC107442, A retrospective case-control study to estimate the sensitivity and specificity of a pharmacogenetic marker (HLA-B5701) in subjects with and without hypersensitivity to Abacavir GlaxoSmithKline 2006-2007
• Principal Investigator, TMC114, Early access of TMC114 in combination with low-dose Ritonavir (RTV) and other antiretrovirals (ARVs) in highly treatment experienced HIV-I infected subjects with limited to no treatment options. Tibotec 2006
• Principal Investigator, LEX106430, A Phase IIIB, randomized, open-label, parallel group, multi-center, non-inferiority, i24 week study to evaluate the safety, efficacy and tolerability of switching from a 200mg ritonavir-boosted regimen of LEXIVA (700mg/100mg BID or 1400mg/200mg QD) to a once daily, 100mg ritonavir-boosted regimen of LEXIVA (1400mg/100mg QD) GlaxoSmithKline 2006

Professional Membership

• Member of College of Physicians, Quebec Canada 1987-
• Member of St-Luc Hospital, Quebec Canada Department of General Medicine 1987-2001
• Member of Medical Council of Canada 1987-
• Member of Canadian HIV trials Network 1994-1996
• Member of Glaxo Wellcome Advisory Board Canada 1994-1996
• Member of Roche Advisory Board Canada 1994-1996
• Member of Provincial Advisory Committee on HIV treatment for the Health Minister of Quebec 1993-1996
• Member of the National Advisory Committee on HIV treatment Drugs Directorate Expert Advisory Committee (Health Protection Branch) for the Health Minister of Canada 1994-1996
• Member of the Glaxo-Smith-Kline speaker’s bureau USA 2005-
• Member of the Dermik-Sanofi speaker’s bureau and National Trainer for Sculptra USA 2004-
• Member of the Serono speaker’s bureau USA 2001-
• Associate, American Academy of Cosmetic Surgery 2007-

Non-Profit Organization Membership:

President Joel Gregory Foundation, Montreal, Quebec Canada 1994-1996

Patents and Publications:

Update on prevention of Pneumocystis carini pneumonia for people infected with HIV Provincial Committee on HIV treatment Montreal, Canada 1993

• Prevention and treatment OF mycobacterium Avium Infection for HIV+ patients Provincial Committee on HIV treatment Montreal, Canada 1993
• The woman and HIV infection: Generality, gynecological aspects on woman infected with HIV and prevention of its transmission sexually Provincial Committee on HIV treatment Montreal, Canada 1994
• Nutritional Approach for HIV+ patients Provincial Committee on HIV treatment Montreal, Canada 1994
• Second Part: The woman and HIV infection: woman HIV+ and pregnancy Provincial Committee on HIV treatment Montreal, Canada 1994
• Diagnosis and treatment of the diarrhea for HIV+ patients Provincial Committee on HIV treatment Montreal, Canada 1995
• Canadian Family Physician Journal 1994; 40:740-5 HIV and Travel Gervais Fréchette MD 2nd author 1994
• Chemotherapy Journal, 1996; 42:374-383 Comparison of Itraconazole and Ketoconazole in HIV+ patients with Oropharyngeal or Esophageal Candidaisis Gervais Fréchette MD, 2nd Investigator, Canada 1996
• 35th Interscience Conference on Antimicrobial Agents and Chemotherapy Effects of Itraconazole in the treatment of oral Candidaisis in HIV+ patient’s double blind double dummy, randomized comparison study with Fluconazole Gervais Fréchette MD, 1st Investigator and oral presentation San Francisco, USA 1995
• XI International Conference on AIDS Saquinavir versus HIVID versus Combination as treatment for advanced HIV+ patients discontinuing or unable to take Retrovir Gervais Fréchette MD, 1st Investigator Vancouver, Canada 1996
• The Lancet, A Randomized trial of addition of Lamivudine or Lamivudine plus Loviride to a Zidovudine containing regimen for HIV+ patients The Caesar trial Gervais Fréchette MD, 2nd Investigator Canada 1999
• Infectious Diseases Journal, A double-blind Comparison of Itraconazole oral Solution and Fluconazole Capsules for the treatment of Oral Candidaisis in AIDS patients Peter Philips, Karl DeBeule, Gervais Fréchette and colleagues