Hospital Affiliations

• Mercy Hospital
• South Miami Hospital
• Baptist Hospital
• Larkin Hospital

Clinical Research Studies:

2002: Investigator Training Course for Medical Research sponsored by University of Rochester School of Medicine and Western Institutional Review Board

2009-Present Protocol no. CQMF149A2210 A randomized, multi-center, parallel group, double blind study to assess the safety of QMF Twisthaler (500/400 µg) and mometasone furoate Twisthaler (400 µg) in adolescent and adult patients with persistant asthma.

2009-Present Protocol no. CIGE025AUS33, A 26-week randomized, double-blind, placebo-controlled, multi-center study to evaluate the effect of omalizumab on markers of asthma impairment in patients wirh persistent allergic asthma.

2009-Present Protocol no. CQAB149B2351, A randomized, double-blind, controlled, parallel group, 12-weel treatment study to compare the efficacy and safety of the combination of indacaterol 150 µg once daily with open label titropium 18 µg once daily versus open label tiotropium 18 µg once daily in patients with moderate-to-severe COPD.

2009-Present Protocol no. CQAB149B2350, A 12-week treatment, multi-center, randomized, parallel group, blinded, double-dummy study to compare the efficacy and safety of indacaterol (150 µg o.d.) delivered via a SDDPI with Tiotropium (18 µg o.d.) delivered via a Handihaler, in patients with moderate-to-severe COPD.

2009-Present Protocol no. CQAB149B2349, A 12-week treatment, multi-center, randomized, parallel group, blinded, double-dummy study to access the superiority of indacaterol (150 µg o.d.) via a SDDPI in patients with moderate to severe COPD, using salmeterol (50 µg bid) as an active comparator delivered via DISKUS.

2007- 2008 Protocol no. CQAB149B2346, A 12-week treatment, multi-center, randomized, double blind, placebo controlled, parallel group study to assess the efficacy and safety of indacaterol (150 ug o.d.) in patients with chronic obstructive pulmonary disease.

2007- 2008 Protocol no. CQAB149B2338, A 26 -week treatment, randomized, multi-center, double blind, double dummy, parallel-group study to assess the safety of indacaterol (300 and 600 ug o.d.) in patients with moderate to persistent asthma, using salmeterol (50 ug bid) as an active control.

2007- 2008 Protocol no. CNVA237A2206, A randomized, double-blind, placebo controlled, parallel group, multi-center study, to assess the safety and tolerability of 28 days treatment with NVA237 (100 or 200ug once a day) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

2007- 2009 Protocol no. CQAB149B2335S / Extension, A 26-week treatment, multicenter, randomized, double-blind, double dummy, placebo-controlled, adaptive, seamless, parallel-group study to assess the efficacy, safety and tolerability of two doses of indacaterol (selected from 75, 150, 300 & 600 ug o.d.) in patients with chronic obstructive pulmonary disease using blinded formoterol (12ug bid) and open label tiotropium (18 ug o.d.) as active controls.

2006- Present Protocol no. D5896C00022, A Phase IIIB, A 52-week, randomized, double-blind, parallel-group, multi-centre, comparing the long term safety of SYMBICORT pMDI 160/4.5 µg x 2 actuations twice-daily to budesonide HFA pMDI 160 µg x 2 actuations twice-daily, in adult and adolescent (= 12 years) African American subjects with asthma.

2006- 2007 Protocol no. F-GT06-153, A Phase III, a randomized, multicenter, double-blind, a Allopurinol-Controlled study assessing the efficacy and safety of oral Febuxostat in subjects with Gout.

2006- Present Protocol no. 01-05-TL-322OPI-002, A Phase III, a multicenter, double-blind study to determine the efficacy and safety of SYR-322 plus Pioglitazone HCl (Actos), SYR-322 Alone or Pioglitazone HCl Alone in Subjects with Type 2 Diabetes.

2006- 2008 Protocol no. LEV106718/BAY12165, A Phase IV, a randomized, double-blinded, placebo-controlled, parallel-group study evaluating the efficacy, safety, and duration of erection of flexible-dose vardenafil administered for 12 weeks compared to placebo in subjects with erectile dysfunction and dyslipidemia.

2006- 2008 Protocol no. 01-05-TL-322OPI-001, A Phase III, Multicenter, Double-Blind, Placebo-Controlled study to determine the efficacy and safety of the combination of SYR-322 (SYR-322) and Pioglitazone HCL (Actos) in subjects with Type II Diabetes.

2006- 2008 Protocol no. TMC125-C214, Early Access of TMC125 in combination with other antiretrovirals in treatment-experienced HIV-1infected subjects with limited treatment options.

2006- 2007 Protocol no. TMC125-C206, A 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.

2006-2006 Protocol no. TMC114-C226, Early access of TMC114 in combination with low-dose ritonavir (RTV) and other antiretrovirals (ARVs) in highly treatment experienced HIV-1 infected subjects with little to no treatment options.

2005-2006 Protocol no. A1481230, Phase IV, Multicenter randomized double-blind, placebo-controlled parallel study of men with mild to moderate Erectile Dysfunction (ED) to evaluate the efficacy of VIAGRA 8 hours post-dose.

2005-2006 Protocol no. A1481240, Phase IV, Multicenter randomized double-blinded, placebo-controlled, parallel study of men with mild to moderate Erectile Dysfunction (ED) to evaluate the efficacy of VIAGRA 8 hours post-dose.

2005-2006 Protocol no. A1481236, Phase IV, A multi-center, double-blind placebo-controlled, flexible-dose study with an open-label phase to assess the efficacy of Sildenafil Citrate on Erectile Dysfunction and intercourse satisfaction as well as to validate the sexual experience questionnaire and its treatment responsiveness in men with Erectile Dysfunction.

2005-2006 Protocol no. A4001027, Phase IIB/III, A Multicenter, randomized double-blind, placebo-controlled trial of 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.

2005-2006 Protocol no. ML 18596/ENF-404, Phase IV, A randomized, open-label, two-way crossover study to assess the tolerability of the B2000 Needle-Free Injection Device (NFID) for administration of Enfuvirtide (ENF).

2004- Present Protocol no. NV17751, Prospective Observational Cohort Study of Pneumonia in Fuzeon-exposed and Non-exposed Patients.

2004-2005 Protocol no. VAR102108, Phase IIIB randomized, double-blinded, crossover study to evaluate the duration of erection following vardenafil (10 mg) administration for 4 weeks in a fixed-dosed regimen compared to placebo in males with Erectile Dysfunction.

2004-2005 Protocol no. ML18018, Phase IV, open-label, Multicenter, cohort study to assess HIV-patient Quality of Life and tolerability after administration of Enfuvirtide-Containing HAART (QUALITE).

2004-2005 Protocol no. ESS101822, Phase IIIB, open-label Multicenter, parallel-arm study designed to evaluate the short-term safety and tolerability of abacavir/lamivudine fixed-dose combination table administered once-daily or the separate abacavir and lumivudine tablets administered twice-daily, as part of the three or four drug regimen, in antiretroviral-naïve HIV-1 infected subjects.

2004-2005 Protocol no. AI424121, A Phase IIIB, open-label, randomized study evaluating the safety and antiretroviral efficacy of Nucleoside Reverse Transcriptase Inhibitor sparing regimens containing Atazanavir, Ritonavir and Efavirenz Once Daily, in the treatment of antiretroviral Naïve HIV-1 infected adults.

2004-2005 Protocol no. 1182.58, A Phase IV open-label safety study to evaluate the safety of Tipranavir plus Ritonovir when used in combination with other agent for the treatment of patients with HIV infection who have failed and/or are intolerant to combination antiretroviral therapy and have limited treatment options.

2003-2005 Protocol no. AI424100, A Phase IIIB, Open-label, Randomized, Multi-center Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir/Ritonovir in HIV-1 Infected Subjects Who Have Achieved Virologic Suppression on a Lopinavir/Ritonavir Based regimen.

2003-2005 Protocol no. A4301010, An Open-label Study of the Pharmacokinetics, Safety and Efficacy of Optimized Viracept Therapy as a Component of HARRT in Treatment-Naïve Subjects.

2003-2004 Protocol no. AUX-TG-214.01, A Phase IV multiple-center, open-label study in males with baseline testosterone levels =300 ng/dL. The objective of this study is to establish the time of onset of sexual function and mood in hypogonadal males with use of Testim 1% gel.

2003-2004 Protocol no. SB-782528/022 (BAY38-9456/100536), A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Reliability of 10 mg Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects with Erectile Dysfunction and Demonstrated Successful First Response to 10 mg Vardenafil.

2003-2004 Protocol no. 4522US/011, A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study of Rosuvastatin (Crestor) 20 mg in the Primary Prevention of Cardiovascular Events Among Subjects with Low Level of LDL-Cholesterol and Elevated Levels of C-Reactive Protein.

2003-2003 Protocol no. MDT3-003, A Four-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once a Day 100, 200, 300 mg Versus Placebo for the Treatment of Pain due to Osteoarthritis of the Knee.

2003-2003 Protocol no. MV16812A, Multicenter, Open-Label, Early Access Program of Fuzeon (Enfuvirtide T-20/Ro 29-9800, HIV-1 Fuzeon Inhibitor) in Combination with Free Choice Antiretroviral Regimen to Assess Serious Adverse Events, Serious AIDS Defining Events, and Tolerability in Patients with Advanced HIV-Infection.

2002-2003 Protocol no. A1481137, A Multicenter, Open-label, Flexible Dose Escalation Study to Evaluate the Correlation Between Event Log Parameters, Self Esteem/Overall Relationship, and Efficacy of Viagra (Sildenafil Citrate) in Men with Erectile Dysfunction.

2002-2003 Protocol no. AI424900, An Open-Label, Muticenter, Non-Comparator early Access Program (EAP) Which Provides Atazanavir to HIV Infected Patients.

2002-2003 Protocol no. C02-010, A Randomized, Multicenter, Double-Blind, Parallel-Designed , 3 Arm study Designed to Compare the Safety and Efficacy of TMX-67 versus Allopurinol. The Study Consist of a 14 day Washout/Run-in Period Followed by a 52 Week Double-Blind Treatment Period.

2002-2004 Protocol no. PR01-29-024, an Open-label Study to Evaluate the Effect of Every Other Week Protocrit (Epoetin alfa) Dosing on maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients.

2002-2004 Protocol no. AI266-406, An Open-Label, Randomized, Multicenter Study Switching HIV-1 Infected Subjects with Viral Load < 50 Copies/mL on a First PI-Based Regimen to Efavirenz Substitute Regimen.

2002-2003 Protocol no. ESS30005, A Phase IV, Open-Label, Multicenter Study of Treatment with Trizivir (Abacavir 300 mg/Lamivudine 150 mg/Zidovudine 300 mg) Twice Daily and Tenofovir 300 mg Once-Daily for 48 Weeks in HIV-Infected Subjects Experiencing Early Virologic Failure (Ziagen Intensification Protocol)

2002-2003 Protocol no. UMD-95-009, Open-Label, Compensated Use of Nitazoxanide for the Treatment of Crytosporidiosis in AIDS Patients.

2002-2003 Protocol no. T-20-305/NV16391, A Phase III open-label safety study of T-20-305/ro 29-9800 (HIV-1 fusion inhibitor) in combination with oral antiretroviral in patients who are unable to construct a viable regimen.

2001-2003 Protocol no. FTC-301 A Randomized Double-Blind, Equivalence Trial Comparing Emtricitabine to Stavudine within a Triple Drug Combination Containing Didanosine Plus Efavirenz in Antiretroviral-Drug Naïve HIV-1 Infected Patients

2001-2003 Protocol no. NR1596, A Randomized, Partially Blinded, Multicenter, Phase III, Three Arm Study Evaluating the Efficacy and Safety of Pegylated-Interferon alfa-2a (Ro 25-8310) Monotherapy versus Combination

Therapy of Pegylated-Interferon alfa 2a with Ribavirin (Ro-209963) versus Combination Therapy of Interferon alfa-2a (Ro-22-8181) with Ribavirin for 48 Weeks of Follow-up in Patients with Chronic Hepatitis C Co-infected with Human Immunodeficiency Virus.

2001-2003 Protocol no. SLGA5011, A Double-Blind, Randomized, Placebo-Controlled Surveillance Study of Asthma Event Outcomes in Subjects Receiving Either Usual Pharmacotherapy of Asthma or Usual Pharmacotherapy Plus Salmeterol 42 MCG (2 Puffs) Twice Daily (SLGA5011).

1987-present ALL EXPANDED ACCESS PROGRAMS FOR HIV DRUGS

2002-2002 Protocol no. HMR3647A/3014, Randomized, Open-Label, Multicenter Trial of the Safety and Effectiveness of Oral Telithromycin (Ketek) and Amoxicillin/Clavulanic Acid (Augmentin) in Outpatients with Respiratory Tract Infection in Usual Care Setting.

2001-2002 Protocol no. GS-00-955, Expanded Access Program for Tenofovir Disoproxil Fumarate (Tenofovir DF) in the Treatment of HIV-1 Infected Patients Who Have Limited Treatment Options.

1999-2000 , Protocol 024, A Non-Comparative, Open, Multisite, Compassionate Use Study to Evaluate the Safety and olerability of MK-0991 for the Treatment of Oropharyngeal and Esophageal Candidiasis, and Invasive Candidiasis and Invasive Aspergillosis in Adults Who are Refractory to or Intolerant of Amphotericin B Lipid Formulations.

1999-2000 ABT-378/r (ABT-378/ritonavir) Early Access Program. Protocol M99-046

1998-1999 The Effect of Weekly Dosing Regimen of Procrit (Epoetin Alfa) on the Quality of Life in the Treatment of Anemia in HIV-Infected Patients on Antiretroviral Therapy - PR 98-29-002.

1997-1999 A Randomized, Open-Label Expanded Access Program to Evaluate the Safety of Preveon (Adefovir diprvoxil) at two dose levels when used in Combination with Other Antiretroviral Agents for the Treatment of Patients with HIV Infection who have Limited Treatment Options. Protocol GS-97-423.

1995-1997 A Phase III Comparative Trial of ABT-538 Alone, AZT alone or the combination of the two in HIV-infected patients without prior antiretroviral therapy (Abbot Protocol M94-247)

1995-1996 A Phase III Safety and Efficacy Trial of ABT-538 plus current vs. Placebo plus Current Therapy in HIV-infected patients (Abbot Protocol M94-247)

1997-1998 A study of the Effect of Two Doses of RS-79070-194 (Gancyclovir ProDrug) on Survival and the Incidence of CMV Disease in HIV Positive patients with asymptomatic CMV Viremia ("PGI"-protocol WV-15377)

1997-1998 A Phase IIIb open-label trial replacing Saquinavir HCG(Ro-31-8959) with Saquinavir SGC (Ro31-8959) in combination with other anti-retroviral drugs in patients with HIV infection(SAQ Protocol Dated February 8,1997)

1997-1998 A Phase II, randomized, Double Blind Placebo-Controlled Study of Combination Drug Anti-Retroviral Therapy to include a reverse transcriptase inhibitor and a prtease inhibitor plus HIV-IT(V) or Placebo in HIV Patients with CD counts>100 ,and HIV RNA>1000 but <10,000.(CS-GT003 dated January 15,1997)

1997-1998 A Phase III Study to evaluate the safety , and antivaril efficacy of 141W94 in combination with AZT and 3TC compared to AZT and 3TC alone in patients with HIVinfection (protocol PRO-AB3001) 1-24-97.

1996-1998 A Phase II Study to investigate the safety, tolerability, pharmacodynamics and antiviral activity of multiple dosing of 141W94 in combination with AZT/3TC in patiemts with HIV infection (PRO-A2002 7/10/96).

1996-1998 A Phase III, Randomized , Double-Blind , Placebo-controlled Study of Viracept in combination with d4T vs d4T alone in HIV positive patients (Protocol AG1343-506 dated 12/27/95).

1996-1998 An Open-Label Study of the safety of oral Gancyclovir for the prevention of CMV disease in people infected with HIV(Protocol GANS 2648 dated 4/23/96).

1996-1997 A pilot PhaseII study of Liarozole in Kaposi's Sarcoma (Protocol LIA-USA34B).

1994-1997 A Randomized open label trial of high dose Atoaquone vs. Low dose Atovaquone vs. Aerosolized Penamidine for prphylaxis of PCP in patients with HIVinfection who are intolerant of Batrim (ATO Protocol 203 dated 6/2/95).

1993-1998 Double blind study of Thymopentin in asymptomatic, HIV-infected patients receiving either mono (AZT or DDI) or combination (AZT/DDI or AZT/DDC) antiretroviral therapy(TP5 study).

1993-1996 A randomized, double-blind study of the efficacy and safety of oral gancyclovir for the prevention of CMV disease in people infected with the HIV.

1993-1994 A pilot randomized , double-blind placebo controlled , paralled design, multi-center trial to evaluate the effect of Ranitidine on Immunologic indicators in asymptomatic HIV infected subjects with a CD4 cell count of between 400-700mm3.

1993-1995 Cervical Disease in HIV-infected Women (AMFAR)

1992-1995 A double-blind comparison of AZT vs. D4T for the treatment of HIV-infected patients with absolute CD4 counts between 50 and 500cells/mm3 following at least 6 months of AZT therapy.

1992-1994 Multi-center, open label study of TLC G 65 single agent loading dose with Subsequent combination therapy in the treatment of disseminated MAC in AIDS patients ( Gentamicin Study TLC91CGO6).

1992-1994 Open-labeled trial of Paromomycin for Cryptosporidiosis in HIV positive patients.

1991-1994 A study of prophylactic Pyrimethamine therapy for the prevention of toxoplasmosis infection in individuals with advanced HIV infection.

1991-1994 Phase II randomized study to evaluate the safety and activity of combination therapy with AZT and IntronA versus AZT alone in patients with asymptomatic to mildly symptomatic HIV infection.

1993-1994 The Observational Data Base Project: A community-based longitudinal study of HIV-infected Individuals (sponsored by AMFAR).

1992-1993 Rifabutin Therapy for the Prevetion of MAC Bacteremia in HIV positive patients with CD4 counts, 200: Treatment IND Study.

1990-1992 Rifabutin therapy for the prevention of MAC Bacteremia in AIDS patients with CD4 counts, 200: A double-blind, placebo controlled trial.

HIV Medical Advisory Boards:

• Abbott Pharmaceutical
• Auxilium Pharmaceutical
• Boehringer Ingelheim Pharmaceutical
• Bristol-Myers Squibb Company
• Gilead Pharmaceutical
• GlaxoSmithKline Pharmaceutical
• Roche Pharmaceutical
• Solvay Pharmaceutical
• Tibotec Pharmaceutical