NAME: Gerald Pierone, Jr., M.D.

OFFICE ADDRESS: Treasure Coast Infectious Disease Consultants
Cardiology & Medicine Associates
3715 7th Terrace
Vero Beach, FL 32960

AIDS Research & Treatment Center
of the Treasure Coast
706 North 7th Street
Ft. Pierce, FL 34952

TELEPHONE: (772) 770-2664 (Vero Beach)
(772) 468-9900 (Fort Pierce)

DATE OF BIRTH: October 16, 1957

PLACE OF BIRTH: Newark, New Jersey

CITIZENSHIP: United States

EDUCATION:

COLLEGE: Carnegie-Mellon University
Pittsburgh, Pennsylvania
September 1975 – May 1976

University of Florida
Gainesville, Florida
B.S., Basic Biological and Medical Science 1980
Graduated with high honors, Phi Beta Kappa

MEDICAL SCHOOL: University of Florida
Gainesville, Florida
M.D., 1983
Junior Honors Medical Program
Alpha Omega Alpha

POST DOCTORAL TRAINING:

RESIDENCY: Internal Medicine
University of Medicine and Dentistry
New Brunswick, New Jersey
PGY I, II, III July 1983-1986
Chief Resident in Internal Medicine
Medical Center at Princeton
Princeton, New Jersey
July 1985 – January 1986

FELLOWSHIP: Infectious Disease
Mount Sinai Medical Center
New York, New York
July 1986 – July 1988

FACULTY APPOINTMENTS: Mount Sinai School Medicine
New York, New York
July 1988 – May 1990
Instructor of Medicine
May 1990 – June 1990
Assistant Professor of Medicine

Florida State University
Tallahassee, Florida
August 2008 – present
Assistant Professor of Medicine

HOSPITAL APPOINTMENTS: July 1988 – June 1990
Assistant Attending Physician
Division of Infection Diseases

October 1988 – June 1990
AIDS Program Coordinator
Mount Sinai Services
City Hospital Center at Elmhurst
Elmhurst, New York

July 1990 – Present
Staff Physician
Indian River Memorial Hospital
Vero Beach, Florida
January 2001 – December 2002
Chairman, Department of Medicine
Indian River Memorial Hospital
Vero Beach, Florida

CERTIFICATION: National Board of Medical Examiners – 1986
American Board of Internal Medicine – 1987
American Board of Internal Medicine
(Infectious Diseases) — 1989

LICENSURE: Florida: ME 57755

PROFESSIONAL SOCIETIES: American Society for Microbiology
Infectious Disease Society of America
International AIDS Society
Physicians Association for AIDS Care
American Academy of HIV Medicine
American Heart Association

PROFESSIONAL ACTIVITIES: ARTCTC:
Founder and Executive Director, 1997 – Present

PUBLICATIONS:

PEER REVIEWED REPORTS:

1. Pierone, Gerald. Candiduria in hospitalized patients. Infections in Med. Pp C-H May 1990.
2. Wheat L.J., Fathering C., Cohen C., Pierone G., et al. for the TIDBID (NR 15520/M61018) study team. Efficacy and safety of twice-daily versus three-times daily saquinavir soft gelatin capsules as part of triple combination therapy for HIV-1 infection. Antiviral Therapy 2002; 7(3): 199-209.
3. Squires K. Pozniak AL, Pierone G., et al. Tenofovir disoproxil flymarate in nucleoside-resistant HIV infection. Ann Intern Med 2003; 139:313-320.
4. Borucki M., Holodiny M., Pierone G., Ruane P., Steinhart C., et al. The safety and tolerability of Z-100 in patients infected with HIV-1. Antiviral Therapy 2006; 11:297-303.
5. Joseph Gathe, David A. Cooper, Charles Farthin, Dushyantha Jayaweera, Dorece Norris, Gerald Pierone, Jr., et al. Efficacy of the Protease Inhibitors Tipranavir plus Ritonavir in Treatment-Experienced Patients: 24-Week Analysis from the RESIST-1 Trial. HIV/AIDS Clinical Infections Diseases 15NOV2006; 43:1337- 46.
6. Pierone G. Jr., Mieras J., Bulgin-Coleman D., Kantor C., Shearer J., Fontaine L., Fath M., Norton M. A pilot study of switch to lopinavir/ritonavir (LPV/r) monotherapy from nonnucleoside reverse transcriptase inhibitor-based therapy. HIV Clin. Trials. 2006 Sep-Oct; 7(5):237-45.
7. Gathe JC., Pierone G., Piliero P., Arasteh K., Rubio R., Lalonde RG., Cooper D., Lazzarin A., Kohlbrenner VM., Dohnanyi C., Sabo J., Mayers D. Efficacy and Safety of Three Doses of Tipranavir Boosted with Ritonavir in Treatment- Experienced HIV Type 1-Infefected Patients. AIDS Research and Human Retroviruses. February 1, 2007, 23(2)L 216-223.
8. Haubrich R., Berger D., Chiliade P., Colson A., Conant M., Gallant J., Wilkin T., Nadler J., Pierone G., Saag M., VanBaelen B., Lefebvre E. Week 24 efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients. AIDS 2007, 21:F11-F18.
9. Walmsley S., Katlama C., Lazzarin A., Areste’h K., Pierone g., Blick G., Johnson M., Meier U., MacGregor T., Leith J. Pharmacokinetics, Safety and Efficacy of Tipranavir Boosted With Ritonavir Alone or in Combination With Other Boosted Protease Inhibitors as Part of Optimized Combination Antiretroviral Therapy in Highly Treatment-Experienced Patients (BI Study 1182.51). J. Acquir Immune Defic. Syndr. 2008;47:429-440.

ADVISORY COMMITTEE PUBLICATIONS:

1. Fichtenbaum CJ., Hadigan CM., Kotler DP., Pierone G., Jr., SAX PE., Steinhart CR., Tebas P.; International Association of Physicians in AIDS Care. Treating morphologic and metabolic complications in HIV-infected patients on antiretroviral therapy. A consensus statement of an advisory committee of the International Association of Physicians in AIDS care. IAPAC Mon. 2005 Feb.; 11(2):38-46.

LETTERS:

1. Pierone Gerald, Turrett Glenn, Masci Joseph, Nicholas Peter. Inhaled Pentamidine in Pneumocystis carinii pneumonia. Lancet 1989; ii:559.
2. Pierone Gerald, Masci Joseph, Nicholas Peter. Pentamidine and Hypoglycemia. Lancet 1989; ii:864.
3. Pierone Gerald, Masci Joseph, Nicholas Peter. Prophylaxis against Pneumocystis carinii pneumonia. Internal Medicine World Report 1989; 4:2.

ABSTRACTS:

1. Pierone Gerald, Masci Joseph, Nicholas Peter, Larson Carol. Long-term use of Zidovudine in AIDS patients. Mount Sinai Research Day. New York, New York. September 27, 1988.
2. Pierone Gerald, Masci Joseph, Nicholas Peter. Trimethoprim-sulfamethoxazole for secondary prophylaxis of Pneumocystis carinii pneumonia in AIDS. V. International AIDS Conference. Montreal, June 7, 1989.
3. Pierone Gerald, Turet Glenn, Masci Joseph, Nicholas Peter. Pyrimethamine- sulfadiazine in the prophylaxis of Pneumocystic carinii pneumonia in AIDS patients with cerebral toxoplasmosis. V. International AIDS Conference. Montreal, June 7, 1989.
4. Masci Joseph, Pierone Gerald, Nicholas Peter. Serum cryptococcal antigen screening in early diagnosis of cryptococcal infection in patients with HIV infection. V. International AIDS Conference. June 7, 1989.
5. Pierone Gerald, Lin Janet, Pottipati Ananthram, Turett Glen, Masci Joseph, Nicholas Peter. The absence of hematologic toxicity of Zidovudine in on-AIDS patients. Mount Sinai Research Day. New York, New York. September 12, 1989.
6. Turett Glen, Pierone Gerald, Masci Joseph, Nicholas Peter. Failure of Doxycycline for cerebral toxoplasmosis in the Acquired Immunodeficiency Syndrome. VI. International Conference on AIDS. San Francisco, California, June 21, 1990.
7. Nicholas Peter, Pierone Gerald, Lin Janet, Gurtman Alejandra, Schechter Clyde, Masci Joseph. Trimethoprim/sulfamethoxazole in the prevention of cerebral toxoplasmosis. VI. International Conference on AIDS. San Francisco, California, June 21, 1990.
8. Pierone Gerald, Lin Janet, Masci Joseph, Nicholas Peter. Fever of Unknown Origin in AIDS. VI. International Conference on AIDS. San Francisco, California, June 21, 1990.
9. Gutman Alejandra, Masci Joseph, Pierone Gerald, Nicholas Peter. The significance of isolated positive CSF cryptococcal antigen tests in HIV-infected patients. VI International Conference on AIDS. San Francisco, California, June 21, 1990.
10. Masci Joseph, Hoffman Howard, Pierone Gerald, Nicholas Peter. Immunological profiles of patients testing HIV+ at an anonymous testing site in New York City. VI. International Conference on AIDS. San Francisco, California, June 20-24, 1990.
11. Farthing C., Norris D., Slater L., Pierone G., Siemon-Hryczyk P., Pilson R., Phillips k., Palleja S. Fortovase (SQV) SGC BID regimens in combination with 2 nucleosides or nelfinavir (NFV) plus 1 nucleoside in HIV-1 infected patients. ICAAC, September 6, 1998.
12. Jemsek, S., Kaga S., Martin G., Pierone G., Labriola D., Manion D.J., Ruiz N.M. Phase II, open label, multicenter study to characterize the effectiveness, safety, and pharmacokinetics of Nelfinavir in combination with DMP 266 in antiretroviral therapy naive or nucleoside analogue experienced HIV infected patients. ICAAC, San Diego, CA, September 6, 1998.
13. B. Dutta, R. Sherer, R. Anderson, G. Pierone, R. Pollard, T. Cooley, Z. Xu. Preliminary results of phase b study on (+) – Calanolide A, a naturally occurring novel NNRTI in treatment of HIV-1 infected patients. 5th International Congress on AIDS in Asia and the Pacific. October 23-27, 1999.
14. Rachlis, S. Becker, J. Gill, E. DeJesus, G. Pierone, J. Kirkland, S. Koosian, D. Farina, N. Ruiz, L. Bessen, S. Villano, and the study 049 team. Successful substitution of protease inhibitors with Sustiva (efavirenz) in patients with undetectable plasma HIV-1 RNA levels – results of a prospective, randomized, multicenter, open-label study (DMP 366-049). ICAAC, Toronto, Ontario, Canada, September 17-20, 2000.
15. S. Becker, A. Rachlis J. Gill, E. Villano. Successful substitution of protease inhibitors with efavirenz in patients with undetectable plasma HIV-1 RNA levels – results of a prospective, randomized, multicenter, open-label study (DMP 266- 049). 5th International Congress on Drug Therapy in HIV Infection, Glasgow, UK., October 22-26, 2006.
16. S. Becker, A. Rachlis, J. Gill, E. DeJesus, G. Pierone, J. Kirkland, S. Koosian, D. Farina, D. Labriola, N. Ruiz, L. Bessen, S. Villano. Successful substitution of protease inhibitors with efavirenz in patients with undetectable viral loads – a prospective, randomized, multicenter, open-label study (DMP 266-049). Slide presentation #20) 8th Conference on Retroviruses and Opportunistic Infections, Chicago, IL. February 4-8, 2001.
17. A. Rachlis, S. Becker, J. Gill, E. DeJesus, G. Pierone, N. Ruiz, E. Aznar. Successful substitution of protease inhibitors with efavirenz in patients with undetectable viral loads – a prospective, randomized, multicenter, open-label study (DMP 266-049). Poster presentation, 1st IAS Conference on HIV Pathogenesis and Treatment, Buenos Aires, Argentina. July 8-11, 2001.
18. K. Squires, G. Pierone, D. Berger, C. Steinhart, N. Bellos, S.L. Becker, S.S. Chen, M.D. Miller, D.F. Coakley, A. Cheng. Tenofovir DF: A 48-week final analysis from a phase III randomized, double-blind, placebo controlled, study in antiretroviral experienced patients. Poster presentation, 9th Conference on Retroviruses and Opportunistic Infections, Seattle, WA, February 24-28, 2002.
19. G. Pierone, J. Mieras, C. Kantor, D. Bulgin-Coleman, D. Wright. Successful switch from stavudine to once daily tenofovir based regimen in patients with fully suppressed HIV. Poster presentation, 40th annual meeting of Infectious Disease Society of America, Chicago, IL, October 24-27, 2002, Abstract 449.
20. Pierone G., Mieras J., Kantor C., Bulgin-Coleman D., Ebrahimi R. Improvements in lipid levels in patients after change from stavudine to tenofovir. Poster presentation, HIV DART 2002, Naples, FL, December 15-19, 2002. Abstract 007.
21. Pierone G., Mieras J., Kantor C., Bulgin-Coleman D., Shearer J., Moore R., Fontaine L., Robinson M. Kaletra (LPV/r) monotherapy for treatment of HIV infection. Poster presentation, HIV DART 2002, Naples, FL, December 15-19, 2002. Abstract 076.
22. Gathe J., Kohlbrenner V., Pierone G., et al. Tipranavir/ritonavir demonstrates potent efficacy in multiple protease inhibitor experience patients: BI 1182.52. Program and abstracts of the 10th Conference on Retroviruses and Opportunistic Infections; February 10-14, 2003; Boston, Massachusetts. Abstract 179.
23. Pierone G., Mieras J., Kanto C., Bulgin-Coleman D., Shearer J., McCabe, J. Lopinavir/r As Sole Therapy for HIV-infection. Oral presentation 9th European AIDS Conference (EACS), Warsaw, Poland, October 25-29m 2003 Forum 1/5.
24. Horban A., Staszewski S., Walmsley S., Pierone G., Sexton A., Stark T. Favorable increases in high-density lipoprotein cholesterol (HDL-C) concentrations in chronic HIVE-infected therapy naive subjects receiving 908/r QD in the SOLO study. Oral presentation 9th European AIDS Conference (EACS) Warsaw, Poland, October25-29, 2003, Forum 8/3.
25. Pierone G., Cho N., Norconk J., Hatten P., Mieras J., Kantor C., Bulgin- Colman D., Shearer J., Platt B. Determination of subclinical atherosclerosis in patients on long-term nevirapine, efavirenz, and protease inhibitor-based antiretroviral therapy by ultrasound measurement of carotid artery intima-media thickness and multislice cardiac CT measurement of coronary artery calcium. Oral presentation XV International AIDS Conference, Bangkok, Thailand, July 11-16, 2004. Abstract 1355.
26. Pierone G., Mieras J., Fontaine L., Fath M., Kanter C., Bulgin-Coleman D., Shearer J., Norton M. Simplification to lopinavir/ritonavir monotherapy from MNRTI-based HAART in HIV-infected patients with complete viral suppression; 24-week interim analysis. Presentation at the XV International AIDS Conference, Bangkok, Thailand, July 11-16, 2004. Abstract 4595.
27. Henry D. Lambiase L., Pierone G., Woodward W., Slim J., LaMarca A., Hoffman-Terry M., Bowers P., Leitz G. Natural history of anemia associated with interferon/ribavirin 9IRN/RBV) therapy for HIV/HCV coinfected patients. Presented at the XV International AIDS Conference, Bangkok, Thailand, July 11- 16, 2004. Abstract 1355.
28. Walmsley S., Leith J., Katlama C., Arasteh K., Pierone G., Blick G., Lazzarin A., Johnson M., Samuels C., Jones P., Chaves R., Quinson A., Kohlbrenner V, McCallister S., Mayers D., Curry K. Pharmacokinetics and safety of tipranavir/ritonavir (TPV/r) alone or in combination with saquinavir (SQV), amprenavir (APV), or lopinavir (LPV): interim analysis of BI1182.51. Presented at the XV International AIDS Conference, Bangkok, Thailand, July 11-16, 2004. Abstract 1236.
29. G. Pierone, J. Mieras, C. Kantor, D. Bulgin-Coleman, J. Shearer, L. Fontaine, M. Fath, M. Norton Genotypic and Phenotypic Resistance Observations Among Patients with Viremia while on Lopinavir/Ritonavir “Monotherapy.” 44th Annual ICAAC, Washington DC, USA, October 3 – November 2, 2004. Abstract H-183.
30. G. Pierone, M. Drulak, K. Arasteh, S. Walmsley, C. Katlama, A. Lazzarin, J. Miki, D. Mayers. A long-term, open-label rollover trial assessing the safety and tolerability of combination tipranavir and ritonavir (TPV/r) use in HIV-1 infected patients. 3rd IAS Conference on HIVE, Rio de Janeiro, Brazil, July 24-27, 2005, Poster BEPe6.2C05.
31. C. Cohen, E. DeJesus, A. Mills, G. Pierone, Jr., P. Kumar, P. Rune, R. Elion, G. Fusco, R. Levy, K. Solomon, S. Erickson-Viitanen. Potent Antiretroviral Activity of the Once-Daily CCR5 Antagonist INCB009471 Over 14 Days of Monotherapy. 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention. Sydney, Australia, July 24, 2007. Abstract TUAB106.

CLINICAL RESEARCH:

HIV/AIDS

Open-label compassionate use of Nitazoxanide for the treatment of Cryptosporidiosis in AIDS patients. (Unimed) 1994.

Noncomparative, multisite, open-label, 48-week study to monitor the safety and tolerability of MK-0639 (Indinavir) 800mg Q8h administered as monotherapy or in combination with reverse transcriptase inhibitor therapy for the treatment of HIV-1 infection in advanced AIDS patients (patients with CD4 counts < 50 cells/mm3) (Merck). Open-label international compassionate treatment program for the use of Saquinavir either as monotherapy or in combination with other anti-retroviral drugs in patients with proven HIV infection. (Roche). Vistide (Cidofovir) intravenous treatment IND protocol for relapsing CMV retinitis in patients with AIDS (Gilead). Double-blind study of Timunox (Thymopentin) in asymptomatic HIV infected patients receiving either mono or combination anti-retroviral therapy. (Immunobiology Research Institute). A randomized, double-blind, active controlled, dose ranging study of the safety and efficacy of chronically administered MDL28574A in the treatment of HIV infected patients. (Hoechst Marion Roussel). Compassionate release program for Lamivudine (3TC) for the treatment of severely immune-compromised HIV infected patients who are intolerant to other approved therapies. (Glaxo). A randomized, blinded evaluation of two doses of Stavudine (d4T) to make treatment available to severely immune-compromised patients with HIV infection who have failed or are intolerant of alternative anti-retroviral therapy. (Bristol-Myers Squibb). A Phase II trial to evaluate the safety and efficacy of recombinant human granulocyte- macrophage colony-stimulating factor (rhu GM-CSF) plus fluconazole vs. fluconazole alone in HIV positive patients with oral candidiasis resistant or refractory to fluconazole. (Immunex). A Phase II trial of recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) and amphoteric in B vs. amphotericin B alone in HIV positive patients with refractory oral candidiasis. (Immunex). Double-blind placebo-controlled study comparing the combination of 15% sp-303 gel with acyclovir vs. acyclovir alone for the treatment of recurrent herpes simplex virus (HSV) infections in subjects with acquired Immunodeficiency syndrome (AIDS). (Shaman/PPD). A Phase II, randomized, double-blind placebo-controlled study of combination drug anti- retroviral therapy to include a reverse transcriptase inhibitor and a protease inhibitor plus HIV-IT (V) or placebo in HIV patients with CD4 counts ? 100, and HIV RNA ? IK, but ? 10K. (Chiron Technologies Center for Gene Therapy). A 1592U89 open-label protocol for adult patients with HIV-1 infection Part B. (Glaxo Wellcome/Clin Trials Research). Sustiva (efavirenz) expanded access program. (DuPont Merck Pharmaceutical Company). Preveon (adefovir dipivoxil) expanded access program for the treatment of patients with AIDS who have failed other antiretroviral therapy and have limited treatment options. (Gilead Sciences). Phase II, open-label, multi-center study to characterize the effectiveness, safety, and pharmacokinetics of Nelfinavir in combination with DMP 266 in antiretroviral therapy naive or nucleoside analogue experienced HIV infected patients. (DuPont Pharmaceuticals/NDS). A Phase IIIB open-label protocol to evaluate Saquinavir Soft Gel (SGC) treatment in combination with other antiretrovirals in HIV positive antiretroviral naive patients. (Hoffmann LaRoche/Barton & Polansky). A phase IB dose-range study to evaluate the safety, pharmacokinetics, and effects of Calanolide A on surrogate marker in HIV-positive patients with no previous antiretroviral therapy. (Sarawak Medichem/Quintiles). A phase III, multicenter, randomized, open-label study to compare antiretroviral activity and tolerability of three different combination regiments (DMP266+zidovudine+larnivudine, Indinavir+zidovudine+lamivudine) in HIV-infected patients. (DuPont Pharmaceuticals). Extended safety evaluation in subjects who have participated in Chiron Technologies Center for Gene Therapy retrovirus protocols. (Chiron Technologies). Evaluation of HIV RNA suppression produced by a triple combination regimen containing an enteric coated formulation of didanosine (ddI EC) administered once daily compared to a reference combination regimen. (Bristol-Myers Squibb). A phase IV, open-labeled, randomized, multicenter 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 regiment versus substitution therapy with efavirenz + the same two nucleoside analogue reverse transcriptase inhibitors in HIV infected patients. (DuPont Pharmaceuticals). An open-label study to evaluate the efficacy and safety of Amprenavir (141 W94) combination therapy in protease inhibitor experience subjects who are intolerant (hyperlipidemia with or without lipodystrophy) but not failing their current protease inhibitor therapy. (Glaxo Wellcome). An open-label study to evaluate the safety and tolerance of Amprenavir (141W94) combination therapy in protease inhibitor experienced subjects who are intolerant (hyperlipidemia with or without lipodystrophy) but not facility their current protease inhibitor therapy. (Glaxo Wellcome). A randomized, double-blind, phase III study of ABT-378/Ritonavir plus stavudine and lamivudine vs. nelfinavir plus stavudine and lamivudine in antiretroviral-naive HIV- infected subjects (Abbot/PPD). A randomized, open-label, phase III study of ABT-378/Ritonavir in combination with nevirapine and two nucleoside reverse transcriptase inhibitors (NRTI's) vs. investigator selected protease inhibitor(s) in combination with nevirapine and two NRTI's in antiretroviral-experienced HIV-infected subjects. (Abbot/PPD). Evaluation of HIV RNA suppression produced by a triple combination regimen containing an enteric coated formulation of didanosine (ddI EC) administered once-daily compared to a reference combination regimen (Bristol-Myers Squibb). A phase III, double-blind, randomized, placebo-controlled multi-center study of the safety and efficacy of tenofovir disoproxil fumarate in combination with other antiretroviral agents for the treatment of HIV-1 infected patients. (Gilead Sciences/PharmaResearch). A randomized, double-blind, placebo-controlled study of AGI549 in combination with Viracept (nelfinavir mesylate) and Combivir (zidovudine + lamivudine) in treatment- naive HIV-infected patients. (Agouron Pharmaceuticals). A phase 3, randomized, double-blind, multicenter study of the treatment of antiretroviral naive, HIV-1 infected patients comparing Tenofovir Disoproxil Fumarate administered in combination with lamivudine and efavirenz versus stavudine, lamivudine and efavirenz. (Gilead Sciences/PharmaResearch). A randomized, open-label study to compare the effect of PROCRIT^® (Epoetin alfa) three times weekly versus once weekly in the treatment of anemia on the quality of life of HIV- infected patients. (Ortho Biotech).

A phase Ib Multicenter, Double-Blind, Placebo-Controlled, Randomized Study on the Safety and tolerability of Z-100 in Early HIV-1 Infected Patients. (Zeria/Quintiles).

A phase III multicenter 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. (Chiron).

A randomized, open-labeled, two arm trial to compare the safety and antiviral efficacy of GW433908/ritonavir QD to nelfinavir BID when used in combination with abacavir and lamivudine BID for 48 weeks in antiretroviral therapy naive HIV-1 infected subjects. (GlaxoSmithKlime).

A randomized partially blinded, multicenter, phase II study investigating the efficacy and safety of Peginterferon alfa-2a (RO 25-8310) and Peginterferon alfa-2a with ribavirin (RO 20-9963) in treatment naive patients with chronic hepatitis C coinfected with human immunodeficiency virus. (Roche/Barton & Polansky)

Double-blind, randomized, dose optimization trial of three doses of tipranavir boosted with low dose ritonavir (TPV/RTV) in multiple antiretroviral drug-experienced subjects. (Boehringer Ingelheim).

An Open-Labeled Study to Evaluate the Effect of every Other Week PROCRIT (Epoetin alfa) Dosing on Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients. (Ortho Biotech/Pharmanet).

Atazanavir 9BMS-232632) for HIV Infected Individuals: An Early Access Program. (Bristol-Myers Squibb).

A Study of Evaluate the Erythropoietic Response to Anemia in HCV/HIV Co-Infected Patients Receiving Combination Ribavirin/Interferon Therapy. (Ortho Biotech).

An open-label, early access program of Fuzeon (Enfuvirtide T-20/RO29-9800, HIV-1 fusion inhibitor) in combination with free choice antiretroviral regimen to access serious adverse events, serious AIDS defining events, and tolerability in patients with advanced HIV-infection. (Roche/Barton & Polansky)

An open-label, randomized, parallel-group study comparing the effectiveness of Procrit (Epoetin alfa) administered once weekly versus standard of care in Hepatitis C/HIV co- infected patients treated with combination of Ribavirin/Interferon. (Ortho Biotech/PharmaResearch).

A randomized open-label study of 800 mg lopinavir/200mg ritonavir QD in combination with tenofovir and emtricitabine vs. 400 mg lopinavir/100mg ritonavir BID in combination with tenofovir and emtricitrabine in HIV infected antiretroviral naive subjects. (Abbott/Covance).

Comparison of Subclinical Atherosclerosis in HIV-Infected Patients Treated with Long- Term Nevirapine versus Efavirenz versus Protease Inhibitor-Based Therapy. (Pierone).

Randomized, open-label, comparative safety and efficacy study of tipranavir boosted with low-dose ritonavir (TPV/RTV) versus genotypically-defined protease inhibitor/ritonavir (PI/RTV) in multiple antiretroviral drug-experienced patients (RESIST 1: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir). (Boehringer Ingelheim)

A Long-Term Open-Label Rollover Trial Assessing the Safety and Tolerability of Combination Tipranavir and Ritonavir use in HIV-1 Infected Subjects. (Boehringer Ingelheim) 2003.

An open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regiment, in multiple antiretroviral (ARV) experienced patients. (Boehringer Ingelheim).

A phase IV, open-labeled pilot study to determine the safety and duration of viral suppression after substitution therapy with Lopinavir/r monotherapy or non-nucleoside reverse transcriptor inhibitor + two nucleoside reverse inhibitors in HIVE-infected patients. (Pierone) 2003.

A Phase III, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of Efavirenz versus Tenofovir when Administered in Combination with the Abacavir/Larmvudine Fixed-Dose Combination Tablet as Once-Daily Regimen in Antiretroviral-Naive HIV-1 Infected Subjects. (GlaxoSmithKline).

A large, simple trial comparing two strategies for management of anti-retroviral therapy (the SMART Study). (CPCRA).

A Phase 3, Randomized, Open-Label, Multicenter Study of the Treatment of Antiretroviral-Naive, HIV1- Infected Subjects Comparing Tenofovir Disoproxil Fumarate and Emtricitabine in Combination with Efavirenz Versus Combivir^® (lamivudine/zidovudine) and Efavirenz. (Gilead/Pharma/Research) 2003.

A Phase IV, Open-Label Pilot Study to Determine the Efficacy of Lopinavir/r and Tenofovir DF as First Salvage in HIV-Infected Patients Experiencing Virologic Failure on a Non-nucleoside-Based Regimen. (Pierone) 2003.

A Phase II randomized, controlled, partially blinded, 48-week trial to investigate dose response of TMC114/RTV in 3-class-experienced, multi PI-experienced HIV-1 infected subjects. Tibotec/PharmaResearch/Medisearch) 2003.

A randomized, double-blind, placebo-controlled, multicenter, dose ranging study to evaluate the efficacy and safety of prosaptide over 6 weeks of treatment for the relief of neuropathic pain associated with HIV-1. (Savient) 2004.

A Randomized, Open-Label Study Assessing Safety, Tolerability, Efficacy, and Metabolic Effects of a Simplified Lopinavir/ritonavir-Based Induction/Maintenance Therapy in Antiretroviral-Naive HIV-Infected Subjects. (Abbott) 2004.

A randomized, double-blind, controlled dose finding study of NGX4010 for treatment of painful HIV-associated distal symmetrical polyneurophathy. (Neurogesx) 2004.

A placebo-controlled, double-blind, parallel dose group study exploring the safety, tolerability, and virological effect of 50, 100, and 200 mg Reverset^TM (RVT) in HIV- infected antiretroviral therapy experienced subjects when used in combination with other antiretroviral agents. (Incyte/Quintiles) 2004.

A Phase IIb, 96-week, randomized, partially double-blinded, multicenter, parallel group, repeat does study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of GW873140 in combination with COMBIVIR (lamivudine and zidovudine) open selected immunological and virological markers of HIV-1 infection in antiretroviral therapy naive adults. (GSK) 2005.

An open-label trail of TMC114/RTV in HIV-1 infected subjects who failed trial treatment in the sponsor selected trials with TMC114. (Tibotec) 2005.

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 subjects. (Tibotec) 2005.

A long-term, open-label, non-randomized study to evaluate the safety of 100 and 200 mg Reverset^TM 9RVT) in HIV-infected antiretroviral therapy-experienced subjects when used in combination with other antiretroviral agents. (Incyte/Quintiles) 2005.

A Multicenter, Randomized, Double-Blind, 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. (Pfizer/Quintiles) 2005.

A Multicenter, Randomized, Double-Blind, 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, Non CCR5-Tropic HIV-1 Infected Subjects. (Pfizer/Quintiles) 2005.

A 12-week, Prospective, Open-label, Multicenter, Cohort Study to Assess HIV-Patient QUALITY of LIFE and Tolerability After Administration of Enfuvirtide-Containing HAART. (Roche) 2005).

Open-label safety study of TMC114 in combination with low dose RTV and other ARVs in highly experienced HIV-1 infected patients with limited or no treatment options. (Tibotec) 2005.

A phase IV, multicenter, cross-sectional study to evaluate the 15OL substitution among subjects experiencing virologic failure on a HAART regimen containing atazanavir. (Bristol Myers-Squibb/PPD) 2005.

A randomized, controlled, open-label trial to compare efficacy, safety and tolerability of TMC114/ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1 infected subjects. (Tibotec) 2005.

A Phase 4, Single-Arm Study to Evaluate the Safety, Antiretroviral Activity and Pharmacokinetics of Tenofovir Disoproxil Fumarate in Combination with Emtricitabine in HIV-1 Infected Patients Experiencing Various degrees of renal Impairment. (Gilead Sciences) 2005).

A 48-week, randomized, open-label, two arm study to compare the efficacy of saquinavir/ritonavir bid plus emtricitabine/tenofovir qd versus lopinavir/ritonavir bid plus emtricitabine/tenofovir qd in treatment-naive HIV-1 infected patients. (Roche/Pharmanet) 2005.

A phase III randomized, double-blinded, placebo-controlled trial to investigate the efficacy, tolerability and safety of TMC125 as a part of ART including TMC114/RTV and an investigator selected OBR in HiV-1 infected subjects with limited or no treatment options. (Tibotec) 2006.

Safety, Pharmacokinetics, and Efficacy of MK-0518 plus Optimized Background Therapy (OBT) vs. OBT alone in HIV Infected Highly Treatment-Experienced Patients. (Merck) 2006.

Phase IV, Open-Labeled, Randomized, Multicenter Study Evaluating Efficacy and Tolerability of Single Table Regimen of Efavirenz/Emtricitabine/Tenofovir DF Compared to Unmodified HAART in HiV-1 Infected Subjects Who Have Achieved Virological Suppression on their HAART Regimen. (Gilead-Bristol Myers-Squibb) 2006.

A phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of a 2mg dose of TH9507, a growth hormone releasing factor analog, in HIV patients with excess of abdominal fat accumulation. (Theratechnologies) 2006.

Early access of MK-0518 in combination with an optimized background antiretroviral therapy (OBT) in highly treatment experienced HIV-1 infected patients with limited or no treatment options (Merck) 2006).

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-naive, or limited ARV-experienced HIV-1 infected subjects. (Incyte) 2006.

An Open-Label Registry Study of the Facial Lipoatrophy Correction Experience with SCULPTRA^® in Subjects with Human Immunodeficiency Virus. (Dermik) 2006.

Early Access of TMC125 in combination with other antiretrovirals in treatment- experienced HIV-1 infected subjects with limited treatment options. (Tibotec) 2007.

A randomized, controlled trial of a weekly schedule of five consecutive days on treatment with efavirenz, tenofovir, and emtricitabine followed by two days off treatment (5/2 intermittent treatment schedule) versus continuous treatment in individuals with virologic suppression on this combination. (Community Research Initiative of New England) 2007.

A Phase 3, Randomized, Open-Labeled Study of Lopinavir/ritonavir Tablets 800/200 mg Once-daily Versus 400/100 mg Twice-daily when Co-administered with Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-experienced, HIV-1 Infected Subjects. (Abbott) 2007.

An Open-label, Multicenter, Mechanism Validation Study to Evaluate the Safety, Efficacy, and Tolerability of KP-1461 as Monotherapy for 124 Days in ARV- experienced, HIV-1-Infected Subjects. (Koronis) 2007.

A Phase 2a, Multicenter, Randomized, Parallel, Double-Blind, Dose Ranging, Pacebo- Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK1349572 Monotherapy Versus Placebo Over 10 days in HIV-1 Infected Adults. (GlaxoSmithKline) 2008.

CLINICAL RESEARCH
ANTIVIRAL

A comparative trial of 256U87 (Valacyclovir) and Acyclovir for the suppression of anogenital herpes infections in HIV infected patients. (Glaxo Wellcome).

A double-blind, randomized, placebo-controlled trial of pleconaril in the treatment of picornavirus respiratory tract disease (viral syndrome caused by picornaviruses). (ViroPharma/Scirex).

An international, randomized, double-blind, placebo-controlled study of valaciclovir for the suppression of recurrent ano-genital HSV infections in HIV-infected subjects. (Glax Wellcome).

A randomized, double-blind, placebo-controlled study to evaluate the impact of inhaled Zanamivir treatment on workplace attendance and healthcare outcomes due to Influenza A and B infections. (Glaxo Wellcome/Clin Trials).

A double-blind, randomized, placebo-controlled trial of a table formulation of pleconaril in treatment of viral respiratory infection. (ViroPharma).

CARDIOVASCULAR

A randomized, double-blind, placebo-controlled trial of the effect of weekly azithromycin on the incidence of coronary artery disease in subjects with evidence of exposure to C. Pneumonia. (Pfizer).

Efficacy and safety study of the oral direct thrombin inhibitor H 376-95 compared with dose-adjusted warfarin (coumadin) in the prevention of stroke and systemic embolic events in patients with atrial fibrillation. (AstraZeneca/Covance) 2002.

Omapatrilat cardiovascular treatment assessment versus enalapril – OCTAVE. (Bristol Myers-Squibb).

REVERT: A multicenter, double-blind, placebo-controlled, randomized trial to evaluate the effect of extended release metoprolol succinate (Toprol-XL^®) on cardiac remodeling in asymptomatic heart failure patients (NYHA Class I) with left ventricular dysfunction. (AstraZeneca/OmniCare) 2002.

TRANSCEND: Telmisartin Randomized Assessment Study in ACE intolerant subjects with cardiovascular Disease. (Boehringer Ingelheim) 2002.

CARDIOVASCULAR

Ongoing telmisartan alone and in combination with ramipril global endpoint trial: A large, simple randomized trial of an angiotension II receptor antagonist (telmisartan) and ACE-inhibitor (ramipril) in patients at high risk for cardiovascular events and including a parallel study. (Boehringer Ingelheim) 2002.

A phase III, multi-center, randomized, double-blind, placebo-controlled, parallel group factorial study of metoprolol succinate extended-release tablets (Toprol-XL), hydrochlorothiazide and their combination in patients with essential hypertension. (AstraZeneca) 2003.

Atrial fibrillation Clopidogrel trial with Irbesartan for prevention of vascular events. (Sanofi) 2003.

Efficacy and safety of Dabigatran Etexilate for the prevention of stroke and systemic embolic events with patients with non-valvular AF in comparison to Warfarin. A prospective randomized, open-label, controlled, multicenter, parallel-group trial. (Boehringer Ingelheim) 2005.

NEUROPATHY

A randomized, double-blinded, controlled dose finding study of NGX4010 for the treatment of painful HIV-associated distal symmetrical polyneuropathy. (Neurgesx) 2004.

A multicenter, open-label, phase II study of NGX-4010 for the treatment of neuropathic pain in patients with painful HIV-associated neuropath (HIV-AN) or postherpetic neuralgia (PHN). (Neurogesx) 2005.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-center trial of Pregabalin versus placebo in the treatment of Neuropathic pain associated with HIV neuropathy. (Pfizer) 2006.

An Open-Label, Extension Safety and Efficacy Trial of Pregabalin in Subjects with Neuropathic Pain Associated with HIV neuropathy. (Pfizer) 2006.

A Multicenter, Randomized, Double-Blind, Controlled Study of NGX-4010 for the Treatment of Painful HIV-Associate Neuropathy. (Neurogesx) 2006.

ANTIBIOTIC

Open-label, single patient emergency protocol for Amphotericin B Lipid Complex in patients with progressive, potentially fatal, fungal diseases. (Liposome Co.).

Double-blind, randomized, comparative, multicenter study of RP-64206 (Sparfloxacin) vs Ciprofloxacin in the treatment of community acquired complicated skin and skin structure infection. (Rhone-Poulenc Rorer).

Dose ranging, double-blind, randomized, multicenter study of Synercid (RP57669/RP4476) vs Ceftriaxone in the treatment of acute bacterial pneumonia. (Rhone-Poulenc Rorer).

A multicenter, three arm comparative study of Cefprozil (250mg BID or 500 mg BID) vs. Amoxicillin/Clavulanate Potassium (500mg TID) in treatment of acute and uncomplicated maxillary sinusitis. (Bristol-Myers Squibb).

Multicenter, double-blind comparative study of intravenous Merrem (Meropenem) and Primaxin (Imipenem-Cilastatin) for the treatment of nosocomial lower respiratory tract infections. (Zeneca).

Ceftibutin vs. Augmentin in the treatment of acute maxillary sinusitis. (Schering Plough).

A randomized, double-blind, multicenter, comparative phase II study of gatifloxacin versus levofloxacin in the treatment of community acquired pneumonia. (Bristol-Myers Squibb).

Comparative safety and efficacy of Cefditoren Pivoxil and Cefuroxime Axetil in the treatment of acute bacterial exacerbation of chronic bronchitis. (TAP Holdings/Paragon).

A randomized, double-blind, multicenter, comparative phase III study of gatifloxacin versus levofloxacin in the treatment of community-acquired pneumonia. (Bristol-Myers Squibb).

Caparison of the safety and efficacy of Clarithromycin IR (250mg BID) or ER (1000mg QD) to Trovafloxacin (200mg QD) for the treatment of community-acquired pneumonia. (Abbott/PPD Pharmaco).

A randomized, double-blind, multicenter, comparative study of gatifloxacin versus clarithromycin in the treatment of acute exacerbation of chronic bronchitis. (Bristol- Myers Squibb).

PULMONARY

A phase II multicenter, randomized, placebo-controlled, double-blind, parallel-group clinical trial to evaluate the safety and efficacy of two doses of Synsorb Cd (8g/day, 16g/day) for the treatment of recurrent Clostridium difficile-associated disease (CDAD). (Synsorb Biotech/CroMedica).

A multinational, multicenter, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of aerosolized recombinant human DNAse I in hospitalized patients with chronic obstructive pulmonary disease experiencing a pulmonary exacerbation. (Genentech).

A 12-week, randomized, double-blinded, positive control, crossover study of albuterol, ipratropium, and the combination, as an inhaled solution in patients with chronic obstructive pulmonary disease. (Dey Pharmaceuticals).