Therafirst Medical Centers
Research
Participation in the following Clinical Protocols as Principal Investigator
CEPHALON, INC
Protocol# CEP-10953 C10953/3023/ES/MN. A 12 month, Open label, Flexible Dosage (100-250 mg/ day) Study of
the safety and Efficacy of CEP-10953 in the Treatment of Patients with Excessive Sleepiness Associated with
narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or in Chronic Shift Work Sleep Disorder.
DERMIK.
Protocol#DL6049-0417 - An Open-Label Registry Study of the Facial Lipoatrophy Correction Experience with
SCULPTRA in Subjects with Human Immunodeficiency Virus (FACES Study)
ADRIA LABS.
Protocol #: 087023--Rifabutin Therapy for the Prevention of Mycobacterium-avium
Complex (MAC) Bacteremia in AIDS Patients with CD4+ Counts < 200: A Double-
Blind, Placebo-Controlled Trial
Protocol # 087027----Rifabutin Therapy for the Prevention of Mycobacterium-avium
Complex (MAC) Bacteremia in AIDS Patients with CD4+ Counts < 200: A Double-
Blind, Placebo-Controlled Trial
Protocol # 087065-- A Double Blind, Random Clinical Trial of a Rifabutin regimen in
Treatment of MAC Bacteremia in Patients with AIDS
Protocol # 087085--Rifabutin Therapy for the Prevention of Mycobacterium-avium
Complex (MAC) Bacteremia in HIV Positive Patients with CD4 Counts < 200:
Treatment IND Study
Protocol # 087250--A Three-Arm Comparative Trial for the Treatment of MAC
Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (900
mg) of Rifabutin (600 mg) or Placebo
Protocol # 112010--Study of the Activity of THF-gamma 2 on HIV Load in HIV
Positive Individuals with CD4+ Cell Counts in the Range of 200 - 500/uL
ABBOTT LABORATORIES.
Protocol #: M91-561--A Prospective, Randomized, Double-Blind, Multicenter, Placebo-
Controlled Study of the Safety and Efficacy of Clatithromycin for the Prevention of
Disseminated Mycobacterium-avium Complex (MAC) Infection in HIV-Infected Patients
with CD4+ Counts < 100 Cells/mm3
Protocol # M91-561X--An Open-Label Extension of the Multicenter Study (M91-561) of
the Safety and Efficacy of Clarithromycin for the Prevention of Disseminated
Mycobacterium-Avium Complex (MAC) Infection in HIV-Infected Patients with CD4+
Counts < 100 cells/mm3
Protocol # M92-806--An Open-Label, Multicenter Study of the Safety and Efficacy of
Clarithromycin Plus Clofazimine With or Without Ethambutol in the Treatment of
Disseminated Mycobacterium-avium Complex (MAC) Infection in HIV-Infected Patients
with CD4+ Counts < 100 Cells/mm3
Protocol # M93-134--Evaluation of Antiviral Activity, Pharmacokinetics, and Safety of
Orally-Administered ABT-538 in HIV-Infected Patients
Protocol # M93-134X--A Long-Term Safety and Antiviral Activity Study of ABT-538
When Administered Orally as Maintenance Therapy to HIV-Infected Patients
Protocol # M94-247 A phase II safety and efficacy trial of ABT-538 plus current
therapy vs placebo plus current therapy in HIV infected patients.
Protocol # M94-245 A comparative trial of ABT-538 alone, zidovudine alone, or the combination of ABT-538
and zidovudine in HIV-infected patients.
AGOURON PHARMACEUTICALS.
Protocol # AG-1343-505
A phase II randomized, double blind, placebo controlled,
dose range-finding study of Viracept as monotherapy in HIV positive patients.
Protocol # AG-1343-511
A phase II, randomized, double blind, placebo controlled,
study of Viracept in combination with Zidovudine and Lamivudine vs Zidovudine and
Lamivudine alone in HIV positive patients with little or no prior antiretroviral treatment
Protocol # AG1549-509 – Title – A Phase II, Single-blind, Randomized, Plecebo-controlled Study of Capravirine
(AG1549) in Combination with VIRACEPT and Two Nucleoside Reverse Transcriptase Inhibitors in HIV-infected
Subjects Who Failed and Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen
Protocol # AG1661-202 – Title – A Randomized, Double-blind, Adjuvant-controlled, Multicenter, Study to Compare
the Virologic and Immunologic Effect of Highly Active Antiretroviral Therapy (HAART) Plus REMUNE Versus
HAART Plus Incomplete Freund’s Adjuvant (IFA) in Antiretroviral-naïve Patients Infected with Human
Immunodeficiency Virus type 1 (HIV-1)
Protocol # AG1343-1260 "A Long Term Safety and Efficacy Study of Viracept in Combination With 2 Nucleoside
Reverse Transcriptase Inhibitors as Initial Treatment in HIV-infected Patients"
Protocol # A4301004 A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of
Nelfinavir-Associated Diarrhea
ALEXION
Protocol# PO6-001. EXamination of PNH, by Level Of CD59 on REd and white blood cells, in bone marrow failure
syndromes (EXPLORE)
ALZA PHARMACEUTICALS.
Protocol# C95-012 A placebo-controlled evaluation on the effect of chronic
testosterone replacement therapy (Testoderm Testosterone Transdermal
System) on body cell mass and body weight in hypogonadal males with AIDS.
Personally involved with nutritional counseling, body composition analysis, and dietary
analysis.
Protocol# C-2002-013 A Placebo-Controlled, Double-Blind, Randomized, Parallel Study of the Efficacy and Safety
of Dapoxetine HCl in the Treatment of Rapid Ejaculation –
Protocol# C-2002-014A Placebo-Controlled, Double Blind, Randomized, Parallel Study of the Efficacy and Safety of
Dapoxetine HCl in the Treatment of Rapid Ejaculation –
Protocol # C2004-004 An Observational Study to Evaluate patient reported Outcomes in Subjects with and without
Premature Ejaculation.
ALEXION
Protocol# PO6-001. Examination of PNH, by Level of CD59 on Red and white blood cells, in bone marrow failure
syndromes (EXPLORE).
AMGEN.
Protocol # GCSF-930101--A Randomized, Controlled, Multicenter Trial of Filgrastim
(Recombinant-methionyl Human Granulocyte Colony Stimulating Factor) for the
Prevention of Grade 4 Neutropenia in Patients with HIV Infection
ASTELLAS
ISN Protocol 3606-CL-3010 “A Phase 4, Multicenter, Double-Blind, Randomized, Placebo-controlled, Study of the
Safety and Tolerance of Regadenoson in Subjects with Renal Impairment”
BIOALLIANCE
Protocol# BA/2004/01/04 - A Comparative Randomized, Double-Blind, Double-Dummy, Multicenter Study of the
Efficacy and Safety of miconazole Lauriad® 50 mg Administered Once a Day and Mycelex® Troches (clotrimazole
10 mg) Administered Five Times a Day in the Treatment of Oropharyngeal Candidiasis in Immunocompromised
Patients
BRISTOL-MYERS SQUIBB.
Protocol # 454-999-01--A Treatment IND (Investigational New Drug) Protocol For
The Use of Videx (2', 3'-Dideoxyinosine, ddI) In Patients With Acquired
Immunodeficiency Syndrome (AIDS) Or AIDS Related Complex (ARC) Who Are
Intolerant To Zidovudine (Retrovir)
Protocol # 454-999-02--An Open-Label Study Regimen of Videx (2', 3'-Dideoxyinosine,
ddI) In Patients With Acquired Immunodeficiency Syndrome (AIDS) Exhibiting
Significant Deterioration While Taking Zidovudine (Retrovir)
Protocol # AI455-019--A Double Blind Comparison of Zidovudine (ZDV) Versus
Stavudine (d4T) (BMY 27857) for the Treatment of HIV-Infected Patients with Absolute
CD4+ Lymphocyte Counts Between 50 and 500 cells/mm3 Following at Least 6 Months
of Zidovudine Therapy.
Protocol # AI455-096004 – Title – Evaluation of the safety and antiviral activity of Stavudine extended release
formulation, as compared to Stavudine immediate release formulation, each as part of potent antiretroviral
combination therapy.
Protocol # A1454-148 – Title – A Randomized Study for the Long-Term Suppression of Plasma HIV RNA Levels by
Triple Combination Regimens in Treatment Naïve Subjects.
Protocol # AI455-900--A Randomized Blinded Evaluation of Two Doses of d4T
(Stavudine) to Make Treatment Available to Severely Immunocompromised Patients with HIV Infection Who Have
Failed or Are Intolerant of Alternative Antiretroviral Therapy.
Protocol # AI424-037: A Phase III Study Comparing the Antiviral Efficacy and Safety of Atazanavir with
Nelfinavir; Each in Combination with Dual Nucleoside Therapy in HIV-Infected Subjects Who Have Failed a
Regimen Not Containing a Protease Inhibitor
Protocol# AI266-406 "VEST-QD: A Phase IV, Open-Label, Randomized, Multicenter Study Switching HIV-1
Infected Subjects with a Viral Load <50 Copies/mL on a First PI-Based Regimen to an Efavirenz Substitution
Regimen"
Protocol#AI424103: “A Phase IIIB, Open-Label, Randomized, Multi-center Study Comparing the Antiviral Efficacy,
Safety, and Effect on Serum Lipids of Atazanavir/Ritonavir Versus Lopinavir/Ritonavir, each in Combination with
Tenofovir and either Didanosine EC or Stavudine XR in HIV-1 Infected Subjects Receiving a NNRTI-Containing
HAART Regimen who are Experiencing their First Virologic Failure”
Protocol# I4243128: A Phase IV, Multi-center, Cross Sectional Study to Evaluate the 150L Substitution Among
Subjects Experiencing Virologic failure on a HAART Regimen Containing Atazanavir (ATV)
Protocol# AI433003Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate
the Antiviral Activity, Safety, Tolerability and Pharmacokinetics of BMS-538158 in HIV-1 Infected Subjects
BOEHRINGERINGLEHEIM PHARMACEUTICALS. INC.
Protocol # 1182.52 TipranavirDouble-blind, randomized, dose optimization trial of three doses of tipranavir boosted
with low dose ritonavir (TPV/RTV) in multiple antiretrovial drug-experienced subjects
Protocol # 1182.17 A Long-Term Open-Label Rollover Trial Assessing the Safety and Tolerability of Combination
Tipranavir and Ritonavir use in HIV-1 Infected Subjects.
Protocol 1182.98 Safety, efficacy and Pharmacokinetics of tipRanavir boosted with low-dose ritonavir (TPV/r) 500
mg/200 mg BID IN a racially and Gender diverse HIV-positive treatment experienced population with a pilot
evaluation of therapeutic drug monitoring (TDM). The SPRING study is an open-label, multicenter, multinational
trial with randomisation to standard of care (SOC) or TDM TPV/r therapy
BIPI Protocol 1182.99: safety and efficacy study of TPV boosted with low dose ritonavir (TPV/r) 500mg/200mg BID
in antiretroviral treatment experienced HIV-positive patients with HCV or HBV co-infection, with a pilot evaluation
of therapeutic drug monitoring (TDM). An open-label, multicenter, multinational trial with randomisation to standard
of care (SOC) or TDM TPV/r therapy.
Protocol 1100.1512-A Phase IV, open-label, randomized clinical trial to compare the virologic efficacy and safety of
nevirapine vs.atazanavir boosted with ritonavir on a background of truvada (tenofovir and emtricitabine), in HIV-1-
infected patients who have received no previous antiretroviral treatment (NEwArT)
Protocol BIPI 1100.1486: A randomised, double blind, double dummy, parallel group, active controlled trial to
evaluate the antiviral efficacy of 400 mg QD nevirapine extended release formulation in comparison to 200 mg BID
nevirapine immediate release in combination with Truvada® in antiretroviral therapy naïve HIV-1 infected patients
GILEAD SCIENCES, INC.
Protocol # GS-97-415 – Title – A Randomised, Double-Blind, Placebo Controlled, Multicenter Study of the Safety
and Efficacy of Adefovir Dipivoxil as Intensification Therapy in Combination With Highly Active Anti-Retroviral
Therapy (HAART) in Patients with HIV-1 RNA >50 and <400 Copies Per ML.
Protocol # 1182.52 TipranavirDouble-blind, randomized, dose optimization trial of three doses of tipranavir boosted
with low dose ritonavir (TPV/RTV) in multiple antiretrovial drug-experienced subjects
Protocol # 1182.17 A Long-Term Open-Label Rollover Trial Assessing the Safety and Tolerability of Combination
Tipranavir and Ritonavir use in HIV-1 Infected Subjects.
Protocol 1182.98 Safety, efficacy and Pharmacokinetics of tipRanavir boosted with low-dose ritonavir (TPV/r) 500
mg/200 mg BID IN a racially and Gender diverse HIV-positive treatment experienced population with a pilot
evaluation of therapeutic drug monitoring (TDM). The SPRING study is an open-label, multicenter, multinational
trial with randomisation to standard of care (SOC) or TDM TPV/r therapy
BIPI Protocol 1182.99: safety and efficacy study of TPV boosted with low dose ritonavir (TPV/r) 500mg/200mg BID
in antiretroviral treatment experienced HIV-positive patients with HCV or HBV co-infection, with a pilot evaluation
of therapeutic drug monitoring (TDM). An open-label, multicenter, multinational trial with randomisation to standard
of care (SOC) or TDM TPV/r therapy.
Protocol 1100.1512-A Phase IV, open-label, randomized clinical trial to compare the virologic efficacy and safety of
nevirapine vs.atazanavir boosted with ritonavir on a background of truvada (tenofovir and emtricitabine), in HIV-1-
infected patients who have received no previous antiretroviral treatment (NEwArT)
Protocol BIPI 1100.1486: A randomised, double blind, double dummy, parallel group, active controlled trial to
evaluate the antiviral efficacy of 400 mg QD nevirapine extended release formulation in comparison to 200 mg BID
nevirapine immediate release in combination with Truvada® in antiretroviral therapy naïve HIV-1 infected patients
GILEAD SCIENCES, INC.
Protocol # GS-97-415 – Title – A Randomised, Double-Blind, Placebo Controlled, Multicenter Study of the Safety
and Efficacy of Adefovir Dipivoxil as Intensification Therapy in Combination With Highly Active Anti-Retroviral
Therapy (HAART) in Patients with HIV-1 RNA >50 and <400 Copies Per ML.
Protocol # - GS-99-907 – Title – A Phase III, Double-Blind, Randomized, Placebo-Controlled Multi-Center Study of
the Safety and Efficacy of Tenefovir Disoproxil Fumarate in Combination with Other Antiretroviral Agents for the
Treatment of HIV-1 Infected Patients.
Protocol# GS-99-910 A Phase III, Open-label, Multicenter Study of the Safety of Tenofovir Disoproxil Fumarate
Administered in Combination with Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients
Protocol 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 600
mg/Emtricitabine 200 mg/Tenofovir Disoproxil Fumarate 300 mg) in HIV-1 Infected, Antiretroviral Treatment-Naive
Adults
Protocol 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-Naive Adults
Protocol GS-US183-0144 : 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
Protocol GS-US183-0145 : 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
GLAXOSMITHKLINE .
Protocol # 107422 A retrospective case-control study to estimate the sensitivity and specificity of a pharmacogenetic
marker (HLA-B*5701) in subjects with and without hypersensitivity to abacavir
Protocol # APV30002. "A Randomized, Open-Label, 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 Naïve HIV-1 Infected Subjects"
Protocol # APV30003: A Phase III, Randomized, Multicenter, Parallel Group, Open-label, Three Arm Study to
Compare the Efficacy and Safety of Two Dosing Regimens of GW433908/ritonavir (700mg/100mg twice daily or
1400mg/200mg once daily) versus lopinavir/ritonavir (400mg/100mg twice daily) for 48 Weeks in Protease Inhibitor
Experienced HIV-Infected Adults Experiencing Virological Failure.
Protocol # APV30005: An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908
Containing Regimens in HIV-1 Infected Subjects
Protocol #APV10017: A Phase I, Parallel, Open-Label, Multicenter, Two Week, Repeat-dose Study Evaluating
Plasma Amprenavir Pharmacokinetics in HIV-1-infected Adult Subjects with Mild or Moderate Hepatic Impairment
Receiving Fosamprenavir + Ritonavir Compared to Matched Control Subjects with Normal Hepatic Function.
Protocol # CAL30001: A Phase III, Randomized, Open-Label, Parallel, Multicenter Study to Evaluate Treatment
with Fixed-Dose Combination of Abacavir/Lamivudine (600 mg/300 mg) Once-Daily versus Abacavir (300 mg)
Twice-Daily and Lamivudine (300 mg) Once-Daily in Combination with Tenofovir Once-Daily and a New PI or
NNRTI for 48 weeks in ART-Experienced HIV-1 Infected Patients.
CCR104627: “A screening protocol to determine eligibility for one of three Phase III treatment studies evaluating
the efficacy and safety of GW873140 in R5-tropic and R5/X4-tropic HIV-1 infected, treatment-experienced subjects
with drug-resistant virus or an observational study in X4-tropic or non-phenotypeable HIV-1 infected, treatment-
experienced subjects with drug-resistant virus”
Protocol#CCR100136: “A Phase IIb, 96 week, randomized, open-label, multicenter, parallel group, repeat dose study
to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of different doses and regimens of
GW873140 in combination with Kaletra (lopinavir and ritonavir) in HIV-1 infected antiretroviral therapy naïve
subjects
Protocol#CCR102709: “A Phase III, randomized, double-blind, placebo-controlled, multicenter, parallel group study
to compare the efficacy and safety of GW873140 400mg BID in combination with a ritonavir-containing optimized
background therapy (OBT) regimen versus placebo plus OBT over 48 weeks in HIV-1 infected, treatment-
experienced subjects with drug-resistant CCR5-tropic virus”
Protocol#CCR104458: “ A Phase III, randomized, double-blind, placebo-controlled, multicenter, parallel group study
to compare the efficacy and safety of GW873140 400 mg BID in combination with a ritonavir-containing optimized
background therapy (OBT regimen versus placebo plus OBT over 48 weeks in HIV1 infected, treatment-experienced
subjects with drug-resistant CCR5/CXCR4-tropic virus”.
Protocol#CCR104629; “ Prospective, Observational Study of Subjects with CXCR4-tropic or Non-phenotypeable
HIV to Assess Changes in Tropism Over Time”.
Protocol # CNA30021: A phase III, 48-week, randomised, double-blind, multicentre study to evaluate the safety and
efficacy of abacavir (ABC) 600mg once-daily (QD) vs abacavir 300mg BID in combination with lamivudine (3TC)
(300mg QD) and efavirenz (EFV) (600mg QD) in antiretroviral therapy naïve HIV-1 infected subjects
Protocol # CNA30024, "A phase III, 1:1 randomized, double-blind, controlled, multicenter trial comparing the
efficacy and safety of abacavir versus zidovudine when combined with lamivudine and efavirenz for treatment of
HIV-1 infection in antiretroviral therapy naive adults"
Protocol # CNA30032: A Retrospective, Case-Control Study to Investigate Genetic Polymorphisms in HIV Infected
Subjects Who Developed Hypersensitivity Following Treatment With Abacavir.
Protocol # COLA4005 – Title – A Phase II, Open-Label, Randomized Study of the Efficacy and Safety of EPIVIR
150mg BID versus EPIVIR 300mg Once Daily when Administered for 24 Weeks in Combination With FDA-
Approved Dosage Regimens of ZERIT and Either CRIXIVAN or VIRACEPT in Subjects With HIV-1 Infection.
Protocol # EPV 20001 - Title – A Phase II/III 48 Week Randomized, Double-Blind, Controlled, Multicenter Study to
Evaluate the Efficacy and Safety of Lamivudine 150mg BID in Combination with Zidovudine 300mg BID and
Efavirenz 600mg Once Daily in Antiretroviral-Naïve Adults with HIV infection
Protocol# EPZ104057: A 96-Week, Phase IV, Randomized, Double-Blind, Multicenter Study of the Safety and
Efficacy of EPZICOM Versus Truvada Administered in Combination with Kaletra in Antiretroviral-Naive HIV-1
Infected Subjects
EPZ#108859, Safety and Efficacy of Atazanavir/Ritonavir for 72 weeks versus a Regimen of Atazanavir/Ritonavir
for 36 weeks followed by Atazanavir for 36 weeks, each in Combination with the Abacavir/Lamivudine Fixed-Dose
Combination for the Initial Treatment of HIV-1 Infection.
Protocol #ESS40003 – Title – Randomized, Multicenter, Open-Label Trial to Evaluate the Reversibility of
Dyslipidemia upon Substitution of Abacavir for a Protease Inhibitor in Virologically Controlled HIV(+) Subjects
with Elevated Cholesterol.
Protocol #ESS30008 A Phase III, 48-Week, Open-Label, Randomized, Multicenter Study of the Safety and Efficacy
of the Abacavir/Lamivudine Fixed-Dose Combination Tablet Administered QD Versus Abacavir + Lamivudine
Administered BID in Combination with a PI or NNRTI in Antiretroviral Experienced Patients.
Protocol# ESS30009: A Phase III, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of
Efavirenz versus Tenofovir when Administered in Combination with the Abacavir/Lamivudine Fixed-Dose
Combination Tablet as a Once-Daily Regimen in Antiretroviral-Naïve HIV-1 Infected Subjects
Protocol #ESS100290-A Phase IIIB/IV, Open-Label, Multi-Center Trial to Evaluate the Safety, Tolerability, and
Efficacy of HIV-1 Infected Subjects Switching Their Current Protease-Inhibitor Therapies for a Fosamprenavir
Therapy Over 48 weeks
Protocol #ESS100327: - A Phase IV Randomized, Multicenter, Open-Label Study to Compare the Safety,
Tolerability and Efficacy of TRIZIVIR (Abacavir 300mg, Lamivudine 150mg, and Zidovudine 300mg) BID vs
COMBIVIR (Lamivudine 150mg and Zidovudine 300mg) BID plus Atazanavir 400mg QD in Antiretroviral Naive
HIV-1 Infected Subjects over 48 Weeks
Protocol #ESS100732: A Phase IIIB, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of
GW433908 (700mg BID) plus ritonavir (100mg BID) Versus Lopinavir/ritonavir (400mg/100mg BID) when
Administered in Combination with the Abacavir/Lamivudine (600mg/300mg) Fixed-Dose Combination Tablet QD
in Antiretroviral-Naïve HIV-1 Infected Adults Over 48 Weeks
Protocol# FBX104114: A Double-Blind, Randomized, Placebo-Controlled Multi-Center, Phase II Parallel Dose-
Ranging Study to Assess the Antifibrotic Activity of GI262570 in Chronic Hepatitis C Subjects with Hepatic Fibrosis
Who Have Failed Prior Antiviral Therapy.
Protocol #HPR10006: “A Pilot, Phase II, Open-Label, Single-Arm Study to Evaluate the Efficacy, Safety,
Tolerability, and Pharmacokinetics of GW640385X when Administered with Ritonavir in combination with
Nucleoside Reserve Transcriptase Inhibitors for 48 weeks in HIV-1 Infected Adults”
Protocol# HPR20001: A Phase IIB, Randomized, Multicenter, Parallel Group Study to Evaluate the Short-Term
Safety, Pharmacokinetics and Antiviral Activity of Four Blinded Dosing Regimens of GW640385/Ritonavir Therapy
Compared to Open-label Current Protease Inhibitor Therapy in HIV-1 Infected, Protease Inhibitor-Experienced
Adults for 2 weeks with Long-Term Evaluation (>48 weeks) of Safety, Pharmacokinetics and Antiviral Activity of
Selected GW640385/Ritonavir Dosing Regimen(s) vs. a Ritonavir-boosted, Protease Inhibitor Containing Regimen
ING112276A Phase IIb study to select a once daily oral dose of GSK1349572 administered with either
abacavir/lamivudine or tenofovir/emtricitabine in HIV-1 infected antiretroviral therapy naïve adult subjects
ING 112961A Phase IIb pilot study to assess the antiviral activity of GSK1349572 containing regimen in
antiretroviral therapy (ART)-experienced, HIV-1 infected adult subjects with raltegravir resistance
Protocol# LESS106430 A Phase IIIB, randomized, open-label, parallel group, multi-center, non-inferiority, 24-week
study to evaluate the safety, efficacy and tolerability of switching from a 200mg ritonavir-boosted regimen of
LEXIVA (700mg/100mg BID or 1400mg/200mg QD) to a once-daily, 100mg ritonavir-boosted regimen of LEXIVA
(1400mg/100mg QD)
Protocol# NN210005: “A Phase I, Multicenter, Randomized, Parallel, Double-Blinded Dose Ranging, Placebo-
Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Dosage
Regimens of GW695634G Monotherapy Versus Placebo Over 7 days in NNRTI-experienced HIV-1 Infected
Adults.”
TOC110978: A Randomized, Double Blind, Double Dummy, Compartative Study to Assess the Safety and Efficacy
of Topical Retapamulin Ointment, 1%, versus Oral Linesolid in the treatment of Secondarily-Infected Traumatic
Lesions and Impetigo Due to Methicillin-Resistant Staphylococcus aureus
HOECHST ROUSSEL PHARMCEUTICALS.
Protocol # 455A A Multicenter, Non-Comparative Trial of the Efficacy of Outpatient
Parenteral Cefotaxime Sodium (Claforan) in the Treatment of HIV Positive Patients with
Infections Caused by Susceptible Pathogens
INTERCOMPANY COLLABORATION FOR AIDS DRUG DEVELOPMENT.
Protocol ICC 001 A master protocol to evaluate the safety and efficacy of multidrug
combination antiretroviral therapy for the treatment of HIV infection.
Protocol ICC 002 A master protocol to evaluate the safety and efficacy of multidrug
combination antiretroviral therapy for the treatment of HIV infection
JANSSEN RESEARCH FOUNDATION
Protocol #: ITR-USA-105--A Third-Party Blinded, Randomized Pilot Study of the
Effect of Sporanox Capsules for the Treatment of Oropharyngeal Candidiasis in HIV-
Positive Subjects
JOHNSON & JOHNSON
PRD R096769-PRE3002 A Placebo-Controlled, Double-Blind, Randomized, Parallel Study of the Withdrawal
Effects of Chronic Daily and as Needed Dosing with Dapoxetine in the Treatment of Premature Ejaculation.
LIGAND PHARMACEUTICALS, INC.
Protocol # L1057T-31 - Title – Randomized Phase 3 Vehicle Controlled Trial of ALRT1057 Topical Gel in Patients
with AIDS related Cutaneous Kaposi’s Sarcoma.
MERCK
Protocol# 004 A Muticenter, Randomized, Double-Blind, Placebo Controlled, Sequential-Design Study to ebaluate
the Lipid Altering Efficacy and Tolerability of MK0354 in Patients with Dyslipidemia.
Protocol 008-00 “A Study to Evaluate the Safety, Tolerability and Immunogenicity of the Human Immunodeficiency
Virus Type 1 (HIV-1) gag DNA Vaccine Formulated with Phosphate Buffered Saline (PBS), or with Aluminum
Phosphate (AIP04), Followed by Ad 5 HIV-1 gag Vaccine (Adenovirus Serotype 5 gag Vector) in a Prime Boost-
Regimen in Healthy Adults”.
Protocol#019 A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and
Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus
Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in
Each of the 3 Classes of Licensed Oral Antiretroviral Therapies
Protocol 112/CRX497“A Muticenter, Open-Label Randomized Study to Compare the Efficacy and Safety of
Indinavir 800 mg b.i.d.. Plus Ritonovir 100 mg b.i.d. Plus Two NRTI’s vs Nelfinavir 1250mg b.i.d. Plus Two NRTI’s
in HIV1 Seropositive Patients Who Have failed an NNRTI Containing Regimen”.
V520-027. A phase IIa Dose-refinement Study of the safety and Immunogenicity
of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 gag/pol/nef/Vaccine in Healthy Adults
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 (protocol # 023-00)
NAPO
Protocol No. NP303-101 (Advent) Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Two-Stage
Study to Assess the Efficacy and Safety of Crofelemer 125mg, 250 mg, and 500 mg Orally Twice Daily for the
Treatment of HIV-Associated Diarrhea (ADVENT Trial)
NEUROGESX.
Protocol C107. A randomized, double blind, controlled dose finding study of NGX-4010 for the treatment of
painful HIV associated distal symmetrical polyneuropathy.
NORVARTIS PHARMACEUTICAL.
Title-SFI-353. A prospective, open-label, multicenter, evaluation of short druation therapy with oral terbinafine
(250mg qd) in the treatment of HIV subjects with tinea cruris/corporis
Title- SFI-355. A prospective, open-label, multicenter, evaluation of short druation therapy with oral terbinafine
(250mg qd) in the treatment of HIV subjects with tinea pedis
Protocol: CFAM810A US07 “ A six month open label, randomized, multi center study to evaluate the comparative
efficacy and safety of oral Famvir (famciclovir in the episodeic (125 mg bid for 5 days) and suppressive treatment
(250 mg bid) of recurrent genital herpes.
NUMICO
A Randomised, Double-blind, Controlled Study on the Effect of One Year Administration of a Nutritional Concept
on Immunological Status in HIV-1 Positive Adults not on Antiretroviral Therapy
ORTHO BIO-TECHNOLOGY.
Protocol # PR97-29-010 PROCRIT (Epoetin alfa).Three Times Weekly Versus Once Weekly In The Treatment of
Anemia on the Quality of Life of HIV-Infected Patients
Protocol PR01-29-024: 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
Protocol # PR00-30-035 A Study to Evaluate the Erythropoietic Response to Anemia in HCV/HIV Co-Infected
Patients Receiving Combination Ribavirin/Interferon Therapy
ORASHURE TECHNOLOGIES
Protocol # PS-072-2 Assessment of the OraQuick HIV ½ Assay for use with Oral Fluid, Whole Blood and
Serum/Plasma Specimens.
Protocol # PS-075-3 Assessment of the OraQuick Rapid HIV-1Antibody Test for use with Plasma Specimens and
Oral Fluid in Known HIV positive Population (April 16, 2003).
ProtocolOQ-HCV-WB-16-Clinical Investigation of the Suitability of the OraQuick Rapid HCV Antibody Test as a CLIA
waived Test
Protocol OQ-HCV-OF-FS-17: Clinical Investigation to Evaluate the Performance of the OraQuick® Rapid HCV
Antibody Test in Fingerstick Whole Blood and Oral Fluid
PFIZER.
A4001027 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.
Protocol #A4001050: A MULTICENTER, OPEN LABEL, EXPANDED ACCESS TRIAL OF MARAVIROC
SAMARITAN PHARMACEUTICALS.
Protocol # SP01A-105-04 A multi-center, double-blind, randomized, placebo-controlled, study of orally
administered SP01A a monotherapy treatment of HIV-infected patients.
Protocol # SP01A-111-05- A multi-center, double-blind, randomized, placebo-controlled, study of orally
administered SP01A for 28 days as monotherapy treatment of HIV-infected patients with evidence of resistance to
currently available antiretroviral therapy.
SCHERING PLOUGH
Protocol# P03672 – 19 Vicriviroc (SCH 417690 ) in Combination Treatment with Optimized ART Regimen
(VICTOR-E1)
P04889-10 Vicriviroc in Combination Treatment with an Optimized ART regimen in Experienced Subjects
(VICTOR-E4; Protocol PO4889).
SERA CARE LABORATORIES.
Clinical Sample Collection
SERONO LABORATORIES.
Protocol # 5341--A Randomized, Parallel Group, Double-Blind, Placebo Controlled
Multicenter Study of Recombinant Growth Hormone (Saizen) in the Treatment of HIV
Associated Catabolism/Wasting
Protocol # 5511--Therapy with Recombinant Human Growth Hormone (Saizen) For
HIV Associated Weight Loss as Continuation Treatment after Serono Study 5341
Serono Laboratories, Inc.
Protocol # 7033--A Randomized, Parallel Group, Double-blind, Placebo-controlled
Multicenter Study With Mammalian Cell-derived Recombinant Human Growth Hormone
(mhGH) in Adults With AIDS-Associated Catabolism/Weight Loss
Protocol # 7305--Therapy With Mammalian Cell-derived Recombinant Human Growth
Hormone (mhGH) for AIDS-associated Catabolism/Weight Loss
Protocol # 9037 – Title – A Phase IV, randomized, parallel group, double blind,
Placebo-controlled, dose-ranging, multicenter study of Serostim, mammalian cell-derived recombinant human growth
hormone (r-hGH[m]), in the treatment of HIV-associated catabolism/wasting.
Protocol # 21747 – Title – A Phase III, multicenter, double blind, randomized, placebo controlled, dose-finding study
of subcutaneously administered Serostim (mammalian cell-derived recombinant human growth hormone, r-h-GH) in
the treatment of Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS).
SHAMAN PHARMACEUTICALS.
Protocol # SP303T-A-01--A Pilot Study to Determine the Safety and Efficacy of
Topically Applied SP-303T in Patients with Acquired Immunodeficiency Syndrome and
Concomitant Herpes Simplex Virus (HSV) Infection Unresponsive to Acyclovir
SYNTEX DEVELOPMENT RESEARCH.
Protocol # GANS2224--An Open-Label Safety Study of Oral Ganciclovir Maintenance
Treatment of CMV Retinitis in People with Limited Venous Access
TAKEDA.
Protocol#01-02-TL-375-022. A Phase III, Open-Label, Fixed –Dose Study to determine the Safety of Long Term
Administration of TAK375 in subjects with Chronic Insomnia.
Protocol# 01-04-TL-375-041 A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Subjective
Response To Treatment With Ramelteon(TAK-375) in Adult Subjects With Chronic Insomnia by Utilizing an
Interactive Voice Response Sytem (IVRS) For Collecting Diary Data
TERAGENIX.
TERA-GC2003V.2 (RMS) Clinical sample Collection
TIBOTEC PHARMACEUTICALS.
Protocol#TMC114-C202. 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.
Therafirst Medical Center
