PETER J. RUANE, MD

1978	M.B., B. CH. University College, Dublin Ireland
1978 - 1979	Medical/Surgical Internship, St. Vincent’s Hospital Rotation, Dublin Ireland
1978 – 1980	Senior house officer in Medicine, Wexford County Hospital, Wexford Ireland,
1980 - 1981	Senior house officer in Medicine, St. Vincent’s Hospital rotation, Dublin Ireland,
1981 – 1984	Internal Medicine Residency, Mayo Graduate School of Medicine, Rochester Minnesota
1984 – 1987	Fellowship, Infectious Disease – West Los Angeles V.A. Medical Center, Los Angeles, CA (Wadsworth Division)

 

Other postgraduate accreditation:

1980 - Member of the Royal College Physicians Ireland (MRCPI)

 

 

Scientific Committees:

1997 – 2001:  Chairman of Institutional Review Board – Midway Hospital Medical Center, Los Angeles, CA

Community Organizations:

2003 – 2008 -  Board Member, AIDS Project Los Angeles (APLA), Los Angeles, California

Professional Associations:

1980	Member of the Royal College of Physicians of Ireland (MRCPI)
1989 – present	Voluntary Faculty Member, ID Teaching Service, Division of Infectious Diseases, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA

1993 – 2006

Board of Directors, Cedars-Sinai Physician Association (Health Source Medical Group) now Prospect HSMG

 

1/14/09 - Maximizing Success While Preserving Future Options: Debating Antiretroviral Treatment Options – Beverly Hills, CA

4/2/09 - Initiating and Improving ARV Therapy: Debating the Data, Reviewing the Options – Beverly Hills, CA

6/10/09 - Individualizing Care in HIV: A Critical Review of Treatment Options – West Hollywood, CA (Ago)

10/21/09 - Effect of Resistance and Resistance Barriers on ARV Therapy Efficacy – Beverly Hills, CA

11/18/09 - Using Clinical Research to Plan and Improve ARV Therapy Decisions – Los Angeles, CA

2/3/10 - The Updated DHHS Guidelines: A Critical Review and Discussion of What’s New and Important – West Hollywood, CA

12/11/11 - HIV/AIDS Care: Reviewing and Addressing the Remaining Challenges – Beverly Hills, CA

7/17/12 - New Antiviral Strategies for Hepatitis C Including Genotype 4, Long Beach, CA

3/14/13 – From Conference to Clinic: Reviewing and Applying Data from the 20th CROI – Beverly Hills, CA

 

 

Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1

David L. Wyles, M.D., Peter J. Ruane et al. July 21, 2015DOI: 10.1056/NEJMoa1503153

 

Reinhardt JF, Ruane PJ, George WL. Intravenous catheter-associated fungemia due to Candida rugosa. J. Clin. Microbiol. 24: 490-492, 1985

 

Ruane PJ, Morgan MA, Citron DM et al.  Failure of rapid agglutination methods to detect oxacillin-resistant Staphylococci aureus also resistant to trimethoprim-sulfamethoxazole and rifampin.  J. Clin. Microbiol; 24: 490-492, 1986

 

Walker R, Ruane PJ, Rosenblatt JE et al.  Comparison of culture, cytotoxicity assays and ELISA for Toxin A and Toxin B in the diagnosis of Clostridium difficile related enteric disease.  Diag. Microbiol. Infect. Dis. 5: 61-69, 1986

 

Reinhardt JF, Johnston L, Ruane P et al. A randomized, double-blind comparison of sulbactam/ampicillin and clindamycin for the treatment of aerobic and aerobic-anaerobic infections. Rev. Infect. Dis. 86: S569-575, 1986

 

Mulligan ME, Ruane PJ, Wong P et al. Ciprofloxacin for eradication of oxacillin-resistant Staphylococci aureus colonization.  American J of Med. 1987.

 

Ruane PJ, Walker JL, George WL. Disseminated infection due to urease-negative Cryptococcus neoformans. J Clin. Microbiol. 26: 2224-2225, 1988

 

Ruane PJ, Reinhardt JF, Nakata M et al.  Spirochete-like organisms in the human gastrointestinal tract. Rev. Infect. Dis.11:184-196, 1989

 

Phillips EH, Carroll BJ, Chandra M, Sullivan LA, Ruane PJ, Decker RW, Rosenfelt FP Laparoscopic-guided biopsy for diagnosis of hepatic candidiasis. J Laparoendosc Surg. 2(1):33-8, Feb 1992

 

Kemper CA, Hostetler JS, Follansbee JE, Ruane P et al Ulcerative and plaque-like tracheobronchitis due to infection with Aspergillus in patients with AIDS  Clin Infect Dis. 17(3):344-52, Sept 1993

 

Schooley R., Ruane P, Myers R, Beall G, et al Tenofovir DF in antiretroviral experienced patients: results from a 48-week, randomized, double blind study. AIDS  16; 1257-1263, 2002

 

Ruane PJ, Parenti DM, Margolis DM, et al. Compact quadruple therapy with the lamivudine/zidovudine combination tablet plus abacavir and efavirenz, followed by the lamivudine/zidovudine/abacavir triple nucleoside tablet plus efavirenz in treatment-naïve HIV-infected adults. HIV Clin Trials 4:231–43, 2003

 

Ruane PJ, Daar ES. What’s next? Treatment options when the first antiretroviral regimen fails virologically or is not tolerated, Part 1. AIDS Read 14:421–6, 431–2, 434, 2004

 

Ruane PJ, DeJesus E. New nucleoside/nucleotide backbone options: A review of recent studies. J Acquir Immune Defic Syndr 37:S21–S29, 2004

 

Ruane PJ, Luber AD. K65R-associated virologic failure in HIV-infected patients receiving tenofovir-containing triple nucleoside/nucleotide reverse transcriptase inhibitor regimens. MedGenMed 6:31, 2004

 

Ruane PJ, Richmond GJ, DeJesus E, et al. Pharmacodynamic effects of zidovudine 600 mg once/day versus 300 mg twice/day in therapy-naive patients infected with human immunodeficiency virus. Pharmacotherapy 24:307–12, 2004

 

Ruane PJ, Kubota MK, Williams AL, et al. Safety/tolerability and efficacy of abacavir-containing combination therapy in HIV-1 infected adults in a clinical practice setting: Results of ZORRO. Infect Dis Clin Pract  2004

 

Lee NE, Taylor MM, Bancroft E, Ruane PJ, Morgan M, McCoy L, Simon PA : Risk factors for community-associated methicillin-resistant Staphylococcus aureus skin infections among HIV-positive men who have sex with men. Clin Infect Dis. 15;40(10):1529-34, May 2005

 

Ruane PJ, Joseph Lang, E De Jesus, el al, Pilot Study of Once-Dailiy Simplification Therapy with Abacavir/Lamivudine/Zidovudine and Efavirenz in HIV-1 Infection. HIV Clin Trials 7(5): 229-236, 2006

 

Borucki M, Holodniy M, Pierone G Jr, Ruane P, Steinhart C, et al.The safety and tolerability of Z-100 in patients infected with HIV-1. Antivir Ther. 11(3):297-303, 2006

 

Ruane, P, Luber, A, Wire, Lou,Y, Shelton, M, Lancaster, C, Pappa, K and COL 10053 Study Team MPHARMACOLOGYPlasma Amprenavir Pharmacokinetics and Tolerability following Administration of 1,400 Milligrams of Fosamprenavir Once Daily in Combination with either 100 or 200 Milligrams of Ritonavir in Healthy Volunteers Antimicrob. Agents Chemother. February 2007; 51:2560-565published ahead of print 6 November 2006doi:10.1128/AAC.00560-06

 

Clotet B, Bellos N, Molina JM, Cooper D, Goffard JC, Lazzarin A, Wohrmann A, Katlama C, Wilkin T, Haubrich R, Cohen C, Farthing C, Jayaweera D, Markowitz M, Ruane P, Spinosa-Guzman S, Lefebvre E; POWER 1 and 2 study groups:  Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: a pooled subgroup analysis of data from two randomised trials. POWER 1 and 2 study groups. Lancet. 7;369(9568):1143-4, Apr 2007

 

Anastasiou,D, Morgan,M, Ruane, P, Steenbergen, J, Katz, Bradley, Alder, J, Thorne,G. In vitro activity of daptomycin against multidrug-resistantStaphylococcus aureus and S. aureus with known virulence factors, includingcommunity-acquiredmethicillin-resistant isolates ☆diagmicrobio.2008.01.012 2.

 

23.  Edwin DeJesus1,*, Jacob P Lalezari2, Olayemi O Osiyemi3, Peter J Ruane4, Robert Ryan5, Thomas N Kakuda5, James Witek6. Pharmacokinetics of once-daily etravirine without and with once-daily darunavir/ritonavir in antiretroviral-naive HIV type-1-infected adults   Antiviral Therapy 2010; 15:711-720

Ruane, PJ, Brian Alas, Robert Ryan, Amy Perniciaro, and James Witek.A 48-Week Pilot Study Switching Suppressed Patients to Darunavir/AIDS Research and Human Retroviruses. November 2010, 26(11): 1215-1219.

 

Daniel J. Skiest1, 2, Calvin Cohen3, Karam Mounzer4, Zach Haigney5, David Barker6, Michael Gottlieb7, Paul C. Bellman8, Edwin Dejesus9, Homayoon Khanlou10, Peter J. Ruane11, Chiu-Bin Hsiao12, Kenneth Abriola13, Bruce Rashbaum14, Nicholaos Bellos15, Douglas.  Similar Efficacy of Raltegravir When Used With or Without a Protease Inhibitor in Treatment-Experienced Patients, Volume 12, Number 3 / May-June 2011

 

Ruane, PJ, Richmond, G, DeJesus, E, Hill-Zabala, C, Danehower,S, Qiming, L, Johnson, J, Shaefer, M.   Pharmacodynamic Effects of Zidovudine 600 mg Once/Day versus 300 mg Twice/Day in Therapy-Naïve Patients Infected with Human Immunodeficiency Virus Article first published online: 16 JAN 2012  DOI: 10.1592/phco.24.4.307.33184

Ruane, PJ; DeJesus, E; Berger, D; Markowitz, M; Bredeek, UF; Callebaut, C; Zhong, L; Ramanathan, S; Rhee, MS; Fordyce, MW; Yale, K  Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of tenofovir alafenamide (TAF) as 10-day monotherapy in HIV-1-positive adults Journal of Acquired Immune Deficiency Syndromes: April 17, 2013.

 

Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of tenofovir alafenamide as 10-day monotherapy in HIV-1-positive adults. Ruane PJ, DeJesus E, Berger D, Markowitz M, Bredeek UF, Callebaut C, Zhong L, Ramanathan S, Rhee MS, Fordyce MW, Yale K. J Acquir Immune Defic Syndr. 2013 Aug 1;63(4):449-55. doi: 10.1097/QAI.0b013e3182965d45.

 

"Sofosbuvir plus Ribavirin in the Treatment of Chronic HCV Genotype 4 Infection in Patients of Egyptian Ancestry" has been selected as a Presidential Poster of Distinction at The Liver Meeting®, AASLD's 64th Annual Meeting in Washington, DC, November 1 - November 5, 2013. Your poster was in the top 10% of all abstracts selected for poster presentation Peter J Ruane et al

 

 

WEBSITE PUBLICATIONS

 

Ruane P, Luber A, Possible Causes of Early Treatment Failure With a Novel ARV Regimen Medscape HIV/AIDS 9(2),  © 2003 Medscape http://www.medscape.com/viewarticle/460673_1, 2003

 

Ruane P:  Induction/Maintenance Strategies for HIV: An Expert Interview With Peter Ruane, MD   http://www.medscape.com/viewarticle/484322 2004, 2004

 

Ruane P.  Expert Column - Simplified Antiretroviral Regimens to Improve Quality of Life Copyright ©  Medscape. http://www.medscape.com/viewarticle/524241, 2006

 

Ruane P.J. Atypical Accumulations of fatty Tissue Abstr I-185 Presented at the 37th ICAAC Toronto 1997

         

Ruane PJ, Zakowski, PC, Sokolov RJ, Uman, SJ, Sinclair D, Impact of New Antiretroviral Therapies on CMV Disease Incidence and Costs. Abstr. N-20 37th ICAAC Toronto 1997

 

Ruane PJ, Tam T,  Zakowski PC,  Sokolov, R,  Uman S, Gaultier C, Musikanth P,  Lapin D. Effective antiretroviral therapy at six months is associated with prolonged Viral Suppression in clinical practice (Abstract I-239 Abstracts of the 38 Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego 1998

 

Gaultier C, Musikanth P, Ruane PJ , Zakowski PC, Sokolov RJ, Uman SJ.    Incidence of Avascular Necrosis of the Hip in HIV infected individuals on HAART (Abstract I-71)  Abstracts of the 38 Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego 1998

 

Miles S., Winters RE, Ruane P Salvage of Multi-drug resistance HIV infection with D4T / 3TC/ Hydroxyurea.  Paper 12205  Presented at the 12th World AIDS conference Geneva July 1998

 

Shaefer M, Eron J, Yetzer E, Ruane P, Becker S, Sawyer G, Graham N Combivir given BID plus a protease inhibitor compared to 3TC 150 BID and ZDV TID plus a protease inhibitor plus PI.  Abstr. 12220 Presented at the 12th World AIDS conference Geneva July 1998

 

Ruane PJ, Tam, JT, Zakowski PC, Uman S.J., Sokolov RJ, Sinclair D, Lappins, D. Recent advances in antiviral therapy for HIV can result in lower total costs Abstr. 24136 Presented at the 12th World AIDS conference Geneva July 1998

 

Ruane PJ, Tam JT, Libraty DL, Sokolov RT, Uman SJ, Zakowski PC. Salvage therapy using ritonavir/saquinavir with a non-nucleoside reverse transcriptase inhibitor after prolonged failure with indinavir or ritonavir.  Abstr. 32308 Presented at the 12th World AIDS conference Geneva July 1998

 

Lalazari J., Beal J., Ruane P., Cohen C., Jacobson E., Sundin D., Smith K. Low-dose subcutaneous IL-2 in combination with HAART therapy induces significant increases in NK cells and naive T-cells in patients with <300 CD4 cells / mm3: Results of randomized controlled trial MA-9801. Abstr. 381, Presented at the 7th CROI, San Francisco, 2000

 

Keerasuntonpong  A, Ruane, P.J., Pitt  J.A., Nichols S., Warford, A. and Daar ES. Cerebrospinal fluid HIV-1 RNA in patients on suppressive antiretroviral therapy. Abstr. 303, Presented at the 7th CROI,  San Francisco, 2000

 

Lalazari J, Beal J, Ruane P, et al. Low-dose subcutaneous IL-2 in combination with HAART therapy induces significant increases in NK cells and naïve T-cells in patients with <300 CD4 cells/mm3: Results of randomized controlled trial MA-9801. Presented at the 7th CROI;; San Francisco, CA. Abstract 381, April 2000

 

Zolopa A, Rice H, Young B, Ruane P, Vaamonde C, Smith P, Henry K, Ritonavir Boosting of Indinavir Regimens in clinical practice: effectiveness, safety, and exploration of phenotypic breakpoints. Presented at the 1st IAS Conference on HIV Pathogenesis and Treatment, Buenos Aires, July 2001.

 

Ruane P, Mendonca J, Timerman A et al.  Kaletra vs nelfinavir in antiretroviral-naïve subjects: Week 60 comparison in a Phase III, blinded, randomized clinical trial.  Presented at the 1st IAS Conference on HIV Pathogenesis and Treatment, Buenos Aires, July 2001.

 

Ruane P, Parenti D, Hessenthaler S, Shepp S, Yau L, St. Clair M, Hernandez J. The PI sparing compact quad regimen of Combivir/Abacavir / Efavirenz is potent and well tolerated in antiretroviral therapy naïve patients with high viral loads: 24 week data. Presented at the 1st IAS Conference on HIV Pathogenesis and Treatment, Buenos Aires, July 2001.

 

Ruane P, Mendonca J, Timerman A, et al. Kaletra vs nelfinavir in antiretroviral-naive subjects: Week 60 comparison in a Phase III, blinded, randomized clinical trial. Presented at the 1st IAS Conference on HIV Pathogenesis and Treatment; Buenos Aires, Argentina. Abstract 6, July 2001

 

Ruane P, Parenti D, Hessenthaler S, et al. The PI-sparing compact quad regimen of Combivir/abacavir/efavirenz is potent and well tolerated in antiretroviral therapy naïve patients with high viral loads: 24 week data. Presented at the 1st IAS Conference on HIV Pathogenesis and Treatment; Buenos Aires, Argentina. Abstract 221, July 2001

 

Hernandez J, Ruane P, Yau L, et al. High incidence of primary NNRTI mutations and M184V in isolates from therapy experienced adults entering the ZORRO trial. Presented at XIV World AIDS Conference; Barcelona, Spain. Abstract TuPeB4585, July 2002;

 

Ruane P, Hernandez J, Richmond G. Genotypic (GH) and virtual phenotypic (vPT) correlates of virologic response to Abacavir (ABC)-based therapy in the ZORRO trial (ESS40009). Presented at XIV World AIDS Conference; Barcelona, Spain. Abstract ThOrB1386, July 2002

 

Bancroft E, Kilgore G, Jones A, Yasuda L, Lee NE, Ruane P, et al. Four outbreaks of community-associated methicillin-resistant Staphylococcus aureus in Los Angeles County. Presented at the 41st Annual Meeting of the Infectious Diseases Society of America; San Diego, California. Alexandria (VA): Infectious Diseases Society of America; Oct 2003

 

Ruane P, Morgan M, Rapp J, et al. Outbreak of clonal MRSA infection in outpatient infectious disease clinic in Los Angeles. 2nd IAS Conference on HIV Pathogenesis and Treatment; Paris, France. Abstract 911., July 13–16, 2003;

 

Ruane P, Luber A, Akil B, et al. Factors influencing selection of K65R mutation among patients receiving tenofovir (TDF)-containing regimens. 2nd IAS Conference on HIV Pathogenesis and Treatment; July 13–16, Paris, France. Abstract 582, 2003

 

Ruane P, Luber A, Gaultier C, et al. Efficacy of trizivir (TZV) and tenofovir (TDF) as HAART for HIV-infected patients with current or underlying reverse transcriptase (RT) resistance. 2nd IAS Conference on HIV Pathogenesis and Treatment; July 13–16, Paris, France. Abstract 593, 2003

 

Ruane P, Luber A, Gaultier C, Stryker R, Anderson D, Peloquin C, Rothbard J  Maintenance therapy using Lopinavir/ritonavir (LPV/r) alone with well-controlled HIV Infection.  World AIDS Conference, Bangkok Thailand. Conference Abstract number: TuPeB4577, 2004

 

Ruane P, Wire M, Shelton Y, et al. Plasma amprenavir pharmacokinetics and safety following co-administration of fosamprenavir with a reduced ritonavir dose once daily (COL10053). 44th ICAAC,  Abstract A-449, 2004

 

Dejesus E, Berger B, Markowitz M, Cohen C, Hawkins T,  Ruane P,   Elion R, Farthing,C, Cheng A,  Kearney B.  The HIV Integrase Inhibitor GS-9137 (JTK-303) Exhibits Potent Antiviral Activity in Treatment-naïve and Experienced Patients. CROI Abstr: 160 LB, 2006

 

P. Ruane, B. Alas. Evaluation of the lipogenic benefit of Fosamprenavir (FPV) when substituted for Lopinavir/r (LPV/r), 8th Workshop on Adverse Drug Reactions and Co-morbidities in HIV, October 2006.

 

 

P Ruane, B Alas, R Ryan, S Fox, A Perniciaro and J Witek.  A Phase IIIb pilot study substituting darunavir/ritonavir (DRV/r) and etravirine (ETR) for enfuvirtide (ENF) and current PI in a suppressive regimen, Ninth International Congress on Drug Therapy in HIV Infection, November 2008.

 

The single-tablet, fixed-dose regimen of elvitegravir/GS-9350/emtricitabine/tenofovir DF (Quad) achieves a high rate of virologic suppression and GS-9350 is an …

C Cohen, D Shamblaw, P Ruane, R Elion… - 17 th Conference on …, 2010

 

Potent antiretroviral activity of the once-daily CCR5 antagonist INCB009471 over 14 days of monotherapy G Pierone Jr, P Kumar, P Ruane . Conference on HIV, 2007.

 

A Phase IIIb pilot study substituting darunavir/ritonavir (DRV/r) and etravirine (ETR) for enfuvirtide (ENF) and current PI in a suppressive regimen

P Ruane, B Alas, R Ryan, S Fox, A Perniciaro… - Headache, 2008 - medadvocates.org

 

Single-tablet, Fixed-dose Regimen of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Achieves a High Rate of Virologic Suppression and GS-9350 Is an Effective BoosterCalvin Cohen*1, D Shamblaw2, P Ruane3, R Elion4, E DeJesus5, H Liu6, L Zhong6, D Warren6, B Kearney6, and S Chuck6 CROI 2010

 

The HIV Integrase Inhibitor GS-9137 Demonstrates Potent Antiretroviral Activity in Treatment-experienced Patients

Andrew R. Zolopa*1, M Mullen2, D Berger3, P Ruane4, T Hawkins5, L Zhong6, S Chuck6, J Enejosa6, B Kearney6, and A Cheng6 CROI 2010

 

The HIV Integrase Inhibitor GS-9137 (JTK-303) Exhibits Potent Antiviral Activity in Treatment-naïve and Experienced Patients  Edwin DeJesus*1, D Berger2, M Markowitz3, C Cohen4, T Hawkins5, P Ruane6, R Elion7, C Farthing8, A Cheng9, B Kearney9, and 183-0101StudyTeam CROi2010

 

Once-Daily vs Twice-Daily Kaletra (Lopinavir/Ritonavir) in Antiretroviral-Naïve HIV+ Patients: 48-Week Follow-UpJ. J. Eron*1, B. Bernstein11, M. King11, L. Manning11, R. Bertz11, G. Beall2, F. Carpio-Cedraro3, J. Feinberg4, H. Horowitz5, D. Wheeler6, H. Kessler7, D. Mildvan8, P. Ruane9, B. Yangco10, C. Renz11, S. Mayer11, and E. Sun, CROI 2012

 

GS-7340 Demonstrates Greater Declines in HIV-1 RNA than TDF during 14 Days of Monotherapy in HIV-1-infected SubjectsM Markowitz1, Andrew Zolopa*2, P Ruane3, K Squires4, L Zhong5, B Kearney5, and W Lee5. CROI 2012

 

GS-7340 25 mg and 40 mg Demonstrate Superior Efficacy to Tenofovir 300 mg in a 10-day Monotherapy Study of HIV-1+ Patients Peter Ruane*1, E DeJesus2, D Berger3, M Markowitz4, F Bredeek5, C Callebaut6, L Zhong6, S Ramanathan6, M Rhee6, and K Yale6  Croi 2012.

 

SPIRIT: Switching to Rilpivirine/Emtricitabine / Tenofovir DF Single-Tablet Regimen from boosted boosted protease inhibitor maintains HIV suppression through week 48 in patients co-infected with HBV or HCV Frank Pallella, Martin Fisher, Pablo tebas, Brian Gazzard, Peter Ruane , Jan van Lunzen et al 9th international workshop on HIV and Hepatitis C Co-infection, May 2013, Rome, Italy, SPIRIT: Switching to Rilpivirine/Emtricitabine / Tenofovir DF Single-Tablet Regimen from boosted boosted protease inhibitor maintains HIV suppression in the black subgroup. ICAAC 2013

 

SPIRIT: Switching to Rilpivirine/Emtricitabine / Tenofovir DF Single-Tablet Regimen from boosted boosted protease inhibitor maintains HIV suppression in the Hispanic/Latino subgroup. Javier Morales-Ramires, martin Fisher, Frank Palella, Pablo tebas, Peter Ruane, David Shamblaw et al Pan-American Infectious Disease Conference 2013, Santiago, Chile

 

Retrospective Comparison of Etravirine and Darunavir/Ritonavir as Dual Therapy in Early Treatment-Experienced Subjects (INROADS) to a Matched Historical Control Cohort Peter Ruane,1 Javier Morales-Ramirez,2 Harold Katner,3 Chiu-Bin Hsiao,4 Bruce Coate,5 Robert Ryan,5 Michelle Cho,6 David Anderson6 EACS 2013 Brussels Belgium

 

 

 

BATON Study (GS-US-164-0115) – “A Phase 4, Prospective, Open-Label, Multi Center Study of the Safety, Efficacy and Adherence In HIV-1 Infected,  Antiretroviral Naïve Subjects Treated With A Simple Once-Daily Regimen of Boosted Atazanavir and Truvada.” 2005

 

TMC125C229 – “An Open-Label Trial of TMC125, In HIV-1 Infected Subjects, who were Randomized To a TMC125 Treatment Arm In A Sponsor-Selected TMC125 trial and Were Treated for At Least 48 Weeks.” 2005

 

TMC114C215 – “An Open-Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-Experienced Subjects.” 2005

 

TMC114C214 – “A Randomized, Controlled, Open-label Trial to Compare the Efficacy, Safety and Tolerability of TMC114/RTV versus LPV/RTV in Treatment-experienced HIV-1 Infected Patients.” 2005

 

TNX-355.03 – “A Phase 2, Multi-center, Randomized, Double-Blinded, Placebo-Controlled, Three-Arm study of the anti-CD4 Monoclonal Antibody TNX-355 with Optimized Background Therapy in Treatment-Experienced Subjects Infected with HIV-1.” 2005

 

Rit-Saq PK Study – Pharmacokinetic Evaluation of Duration of Ritonavir Boosting Among Healthy Volunteers Taking Once-Daily Saquinavir-Ritonavir (SAQ-RTV).” 2005

 

P03672 – “Phase III Trial To Demonstrate Viral Efficacy of Vicriviroc (SCH 417690) Compared To Placebo In Combination With An Optimized ART Regimen In CCR5 Tropic HIV Infected Individuals Failing A Standard Three-Drug ART Regimen.”  2005

 

P04285 – “Phase III Trial To Demonstrate Viral Efficacy of Vicriviroc (SCH 417690) Compared To Placebo In Combination With An Optimized ART Regimen In CCR5/CXCR4 Mixed-Tropic HIV Infected Individuals Failing A Standard Three-Drug ART Regimen.” 2005

 

Vertex 1001 – “Evaluation of the Lipogenic Benefit of fos-Amprevavir (Lexiva) Unboosted When Substituted for Lopinavir/r (Kaletra;LPV/r) in Patients Without Underlying  PI Resistance??? (2005)

 

GRZ107460 –  A Phase 2a, Multicenter, Randomized, Parallel, Double-Blind,  Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK364735 Monotherapy Versus Placebo Over 10 days in HIV-1 Infected Adults.” 2006

 

AI266073 – Phase IV, Open-label, Randomized, Multicenter, Study Evaluating Efficacy and Tolerability of Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir DF Compared to Unmodified HAART in HIV-1 Infected Subjects Who Have Achieved Virological Suppression on their HAART Regimen.” 2006

         

INCB 9471-201 – A randomized, double-blind, placebo-controlled study exploring the safety, tolerability, pharmacokinetics and virological effect of once daily oral dosing of INCB009471 as monotherapy for 14 days in ARV-naïve or limited ARV-experienced, HIV-1 infected subjects.” 2006

 

GS-US-183-0105 – “A Phase 2, Randomized Study of the Treatment of Antiretroviral Treatment-Experienced, HIV 1 Infected Subjects Comparing Ritonavir-Boosted GS 9137 (GS 9137/r) Versus a Comparator Ritonavir-Boosted Protease Inhibitor (CPI/r) in Combination with a Background Antiretroviral Therapy.”  2006

 

A4001028 – “A Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Trial Of A Novel CCR5 Antagonist, UK-427,857, In Combination with Optimized Background Therapy Versus Optimized Background Therapy Alone For The Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects.”  2006

 

TMC125c206 – “Phase III randomized, double-blinded, placebo-controlled trial to investigate the efficacy, tolerability and safety of TMC 125 as part of an ART including TMC 114/RTV and an investigator-selected OBR in HIV-1 infected subjects with limited to no treatment options.”  2006

 

GS-US-183-0101 – “A Double-Blind, Randomized, Placebo-Controlled Phase 1/2 Study of the Safety, Pharmacokinetics, and Antiviral Activity of GS‑9137 Following Oral Administration in Subjects Infected with.”  2006

 

TMC125 -C206 –“Phase III randomized, double-blinded, placebo-controlled trial to investigate the efficacy, tolerability and safety of TMC 125 as part of an ART including TMC 114/RTV and an investigator-selected OBR in HIV-1 infected subjects with limited to no treatment options.”  2006

 

A4001028 – “A Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Trial Of A Novel CCR5 Antagonist, UK-427,857, In Combination with Optimized Background Therapy Versus Optimized Background Therapy Alone For The Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects.”  2006

 

GS-US-183-0105 – “A Phase 2, Randomized Study of the Treatment of Antiretroviral Treatment-Experienced, HIV 1 Infected Subjects Comparing Ritonavir-Boosted GS 9137 (GS 9137/r) Versus a Comparator Ritonavir-Boosted Protease Inhibitor (CPI/r) in Combination with a Background Antiretroviral Therapy.”  2006

 

INCB 9471-201–“A randomized, double-blind, placebo-controlled study exploring the safety, tolerability, pharmacokinetics and virological effect of once daily oral dosing of INCB009471 as monotherapy for 14 days in ARV-naïve or limited ARV-experienced, HIV-1 infected subjects.” 2006

 

AI266073 – “Phase IV, Open-label, Randomized, Multicenter, Study Evaluating Efficacy and Tolerability of Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir DF Compared to Unmodified HAART in HIV-1 Infected Subjects Who Have Achieved Virological Suppression on their HAART Regimen.” 2006

 

TMC114-C226 –“Early Access of TMC114 In Combination With Low-Dose Ritonavir (RTV) and Other Antiretrovirals (ARV’s) In Highly Treatment Experienced HIV-1 Infected Subjects With Limited To No Treatment Options.” 2006

 

TMC125-C214 – “Early Access of TMC125 in combination with other antiretrovirals in treatment-experienced HIV-1 infected subjects with limited treatment options.” 2007

 

V520-027 – Sub-PI “A Phase IIa Dose-Refinement Study of the Merch Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5-HIV-1 Trivalent Vaccine in Healthy Adults.” 2006

 

A4001050 – “A Multicenter, Open Label, Expanded Access Trial of Maraviroc.” 2007

 

P04999-058 (COVER) – “A non-randomized, prospective, observational, multi-site registry for subjects with HIV who discontined participation in Phase 2 and 3 VCV studies.” 2007

 

GS-US-183-0130 – “A Phase 2, Open-Label, Multicenter Study of the Safety of Ritonavir-Boosted GS 9137 (GS 9137/r) Administered in Combination with Other Antiretroviral Agents for the Treatment of HIV 1 Infected Subjects.” 2007

 

MK-0518 Protocol 023 – “Early Access of MK-0518 in Combination with an Optimized Background Antiretroviral Therapy (OBT) in Highly Treatment Experienced HIV-1 Infected Patients with Limited to No Treatment Options.” 2007

 

TMC114HIV3009 – “Open label Phase 3b, 48 week pilot study of the antiviral efficacy and tolerability of the combination of PREZISTA/r and TMC125 when substituted for enfuvirtide, current protease inhibitor(s) and NNRTI(s) in antiretroviral resistant patients with viral suppression but who are intolerant of enfuvirtide.” 2007

 

TMC114-TiDP31-C229 – “A randomized, open-label trial to compare the efficacy, safety and tolerability of DRV/rtv (800/100 mg) q.d. versus DRV/rtv (600/100 mg) b.i.d. in early treatment-experienced HIV-1 infected subjects.” 2007

 

TMC125HIV2032 – “A multicenter study to evaluate the pharmacokinetic profile and safety of TMC125 plus tenofovir DF / emtricitabine all dosed once daily with and without darunavir (PREZISTA™) / ritonavir once daily in antiretroviral naïve HIV-1 infected subjects.” 2008

 

KD-1002 – “A Study of the safety, tolerability and pharmacokinetics of KD-247, a humanized monoclonal antibody that recognizes the principal neutralizing determinant of HIV-1, in asymptomatic HIV-1 seropositive individuals who are not receiving concurrent antiretroviral therapy.” 2008

 

 

“A Phase 2a, Randomized, Double-Blind, Placebo-controlled Study of PRO 140 by Subcutaneous Administration in Adult Subjects with Human Immunodeficiency Virus Type 1 Infection.” 2008

 

P04889 – “Vicriviroc in Combination Treatment With an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E4).” 2008

 

MK-0518 Protocol 032 – “A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Kaletra in HIV-Infected Patients Switched from a Stable Kaletra-Based Regimen-Study A.” 2008

 

MK-0518 Protocol 033 – “A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Kaletra in HIV-Infected Patients Switched from a Stable Kaletra-Based Regimen-Study B.” 2008

 

TMC278-C215 – “A Phase III, randomized, double-blind trial of TMC278 75 mg q.d. versus efavirenz 600 mg q.d. in combination with a fixed background regimen consisting of abacavir and lamivudine in antiretroviral-naïve HIV-1 infected subjects.” 2008

 

IISP #33040 – “Open label Phase 4, 48 week pilot study of the antiviral efficacy and tolerability of the combination of Isentress™ and Reyataz™ when substituted for current antiviral regimen in patients with viral suppression but who are experiencing adverse events related to their current antiviral regimen.” 2008

 

SWIFT Study (GS-US-164-0216) – “A Prospective, Randomized, Open-Label Phase IV Study to Evaluate the Rationale of Switching from Fixed-Dose Abacavir (ABC)/Lamivudine (3TC) to Fixed-Dose Tenofovir DF (TDF)/Emtricitabine (FTC) in Virologically-Suppressed, HIV-1 Infected Patients Maintained on a Ritonavir-Boosted Protease Inhibitor-Containing Antiretroviral Regimen.” 2008

 

GS-US-183-0144 – “A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV 1 Infected, Antiretroviral Treatment-Experienced Adults.” 2008

 

MK-0518 Protocol 071 – “A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK-0518) Versus Twice Daily Raltegravir, Each in Combination With TRUVADA, in Treatment-Naïve HIV Infected Patients.” 2008

 

TMC114HIV4023  – “A multicenter, open-label, randomized study to assess the metabolics, efficacy, and safety of once-daily darunavir versus atazanavir in HIV-infected treatment-naïve adult patients.” 2008

 

PRO 140 2101 – “A multicenter, open-label, randomized study to assess the metabolics, efficacy, and safety of once-daily darunavir versus atazanavir in HIV-infected treatment-naïve adult patients.” 2008

 

GS-US-183-0144/0145

“A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults” 2009

 

45. GS-US-216-0105

“A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9350-boosted Atazanavir (ATV/GS-9350) compared to Ritonavir-boosted Atazanavir (ATV/R) in Combination with Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults” 2009

 

46.  GS-US-236-0104

“A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Atripla (Efavirenz 600mg/Emtricitabine 200mg/Tenofovir Disoproxil Fumarate 300mg) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults” 2009

 

47. 08-072 (Bravo Study)

 “Outcomes of the Early Raltegravir Experience: Comparison of Virologic Response In Regimens Not Containing a Protease Inhibitor in the Antiretroviral Background Regimen versus regimens containing a protease inhibitor in the background regimen” 2008

 

48.  Progenics

“A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of Pro 140 by Subcutaneous Administration in Adult Subjects with Human Immunodeficiency Virus Type 1 Infection” 2008

 

49.  COL11294 (Bullet Study)

“Boosted Lexiva with Lovaza Adjunctive Therapy in HypERTriglyceridemic, HIV-Infected Subjects (BuLLET Study)” May2009

 

50.  P04875  “Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects” Jan2009

 

51. Tobira 652-2-201  “A Proof of Concept, Multiple Dose-Escalating Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of the CCR5 Antagonist TAK-652 in HIV-1-Infected, Antiretroviral Treatment-Experienced, CCR5 Antagonist-Naïve Patients” 2009

 

52.GS-US-164-0216 (SWIFT Study)  “A Prospective Randomized, Open Label Phase IV Study to Evaluate the Rationale of Switching from Fixed Dose Abacavir (ABC)/Lamivudine (3TC) to Fixed-Dose Tenofovir DF (TDF)/Emtricitabine (FTC) in Virologically-Suppressed, HIV-1 Infected Patients Maintained on a Ritonavir-Boosted Protease Inhibitor Containing Antiretroviral Regimen” 2009

 

53. ING111762 (Sailing Study) – “A Phase III Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50mg Once Daily Versus Raltegravir 400mg Twice Daily, Both Administered with an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naive, Antiretroviral Therapy-Experienced Adults" Dec2009

 

54. NK-105.4.05 US (KOWA Study)

“A 12-Week, Randomized, Double-Blind, Active-controlled, Parrallel-Group Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects with Dyslipidemia, followed by a 40-Week Safety Extension Study” Dec2009

 

55. GS-US-236-0102

“A Phase 3, Randomized, Double-Blind Study to Evaluate the Sfety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment Naïve Adults” Dec2009

 

56. GS-US-236-0103

“A Phase 3, Randomized, Double -Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment Naïve Adults” Dec2009

 

57. GS-US-216-0114 (July2010)

“A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered with Emtricitabie/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment Naïve Adults” Dec2009

 

 

58.TMC278-TiDP6-C222

“An open-label trial with TMC278 25mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in HIV-1 Infected subjects, who participated in TMC278 clinical trials” Dec2010

 

59.ING111762 (Sailing Study) –

“A Phase III Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50mg Once Daily Versus Raltegravir 400mg Twice Daily, Both Administered with an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naive, Antiretroviral Therapy-Experienced Adults" Dec2009

 

60. GS-US-264-0106

“A Phase 3B Randomized, open-Label Study to Evaluate Swithching from Regimens Containing a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Combination Tablets in Virologically-Suppressed, HIV-1 Infected Patients” Jan2011

 

61. GS-US-292-0102

“A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen in HIV-1 Infected, Antiretroviral Treatment-Naive Adults” Nov2011

 

62. GS-US-236-0121

“A Phase 3b randomized, Open-Label study to Evaluate Switching from Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor plus Truvada to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (EVG/COBI/FTC/TDF) Single Tablet Regimen in Virologically-Suppressed, HIV-1 Infected Patients” Oct2011

 

63. GS-US-236-0115

“A Phase 3b Randomized, Open-Label Study to Evaluate Switching from Regimens Consisting of a Ritonavir-boosted Protease Inhibitor plus Emtricitabine/Tenofovir Fixed-Dose Combination (FTC/TDF) to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically-Suppressed, HIV-1 Infected Patients”

 

64. GS-US-216-0130

“A Phase 3b, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Cobicistat-boosted Darunavir Plus Two Fully Active Nucleoside Reverse Transcriptase Inhibitors in HIV-1 Infected, Antiretroviral Treatment-Naïve and –Experienced Adults with No DRV Resistance-associated Mutations” Aug2011

 

65. GS-US-236-0118

“A Phase 3 Open-label Safety Study of Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients with Mild to Moderate Renal Impairment” Jul2011

 

66. GS-US-264-0111

“A Phase 2B Open-Label Pilot Study to Evaluate Swithcing from a Regimen Consisting of a Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Single Tablet Regimen (STR) to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) STR in Virologically-Suppresed, HIV-1 Infected Subjects” Jan2011

 

67. GS-US-264-0110

“A Phase 3B, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of a single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared with Single Tablet Regimen of Efavirenz/Emtricitabine.Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive adults” Jan2011

 

68. GS-US-120-0104

“A Phase I Randomized, Partially-Blinded, Active and placebo-Controlled Study of Safety,

 

69. GS-US-236-0123

“A Phase 3B Open-Label Pilot study to Evaluate Switching from a Regimen Consisting of Raltegravir plus Emtricitabine/Tenofovir Fixed-Dose Combination (FTC/TDF) to the

Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) (EVG/COBI/FTC/TDF) in Virologically-Suppressed, HIV-1 Infected Patients” Dec2011

 

 70. GS-US-299-0102

“A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Darunavir/Cobicistat /Emtricitabine/GS-7340 Single Tablet Regimen Versus Cobicistat-boosted Darunavir plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults” Mar2012

 

 

Hepatis C Research Studies

 

71. GS-US-248-0131

“A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection” Mar2012

 

72. Protocol ID: P7977-1231

A Phase 3, Multicenter, Randomized, Active-Controlled Study

to Investigate the Safety and Efficacy of PSI-7977 and

Ribavirin for 12 Weeks Compared to Pegylated Interferon and

Ribavirin for 24 Weeks in Treatment-Naïve Patients with

Chronic Genotype 2 or 3 HCV Infection          July 2011

 

73. Protocol BI 1220.47

A phase III, randomised, double-blind and placebo-controlled study of

once daily BI 201335 120 mg for 24 weeks and BI201335 240 mg for

12 weeks in combination with pegylated interferon-? and ribavirin in

treatment-naive patients with genotype 1 chronic hepatitis C infection.

June 2011

 

74. TMC435-TiDP16-C212

A Phase III open-label study to evaluate the safety, tolerability and

efficacy of TMC435 plus PegIFN?-2a (Pegasys®) and ribavirin

(Copegus®) triple therapy in chronic hepatitis C genotype-1 infected

subjects who are co-infected with human immunodeficiency virus type 1

(HIV-1).  July 2011

 

75. GS-US-334-0110

A Phase 3, Multicenter, Open-Label Study to Investigate the

Efficacy and Safety of GS-7977 with Peginterferon Alfa 2a and

Ribavirin for 12 Weeks in Treatment-Naïve Subjects with

Chronic Genotype 1, 4, 5, or 6 HCV Infection  May 2012

 

 76. GS-US-334-0114

A Phase 2, Randomized, Open-Label Study to Evaluate the

Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered

for Either 12 or 24 Weeks in Treatment-Naïve and

Treatment-Experienced Egyptian Adults with Chronic

Genotype 4 HCV Infection..   July 2012