Therafirst Medical Centers Research Participation in the following Clinical Protocols as Principal Investigator 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 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) 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.