CLINICAL TRIAL HISTORY LIST

Clinical Research Coordinator III
Phase I, II, III and IV.

bioLytical:

Protocol: CLS-011 A Study to Evaluate the Clinical Performance, Usability and Readability of the iStatis Covid-19 Ag Rapid Test performed with Anterior Nasal Swabs.

CBCC:

CBCC HUMAN FACTOR Pramilintide Acetate Pen Injectors: Comparative Human Factors Study Protocol for SUN Pramlintide Acetate Pen Injector compared to SymlinPen® (AstraZeneca Pharmaceuticals LP) in Subjects with Type 1 and Type 2 Diabetes: A Randomized, Four-Sequence, Crossover, Multiple-Site, Study to Evaluate the Use Success Rate of Pramlintide Acetate Pen (Sun Pharmaceutical Industries Ltd.) Compared to SymlinPen® (AstraZeneca Pharmaceuticals LP) in Subjects with Type 1 and Type 2 Diabetes

CEPHEID:

Protocol: CEPHEID-199 A Study to Evaluate the Clinical Performance, Usability and Readability of the Cepheid Xperta® MRSA NxG Assay. Protocol: CEPHEID- 007A A Study to Evaluate the Clinical Performance, Usability and Readability of the Cepheid Fingerstick HCV VL Assay

DIABETIC FOOT ULCERS:

Protocol: DBC-PUL-02 A Multic-center, Randomized Controlled Clinical Investigation Evaluating Wound Closure with OptiPulseTM versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
Protocol:
RD006SG RedDress Ltd. / “A Multi-Center, Prospective, Randomized, Controlled Trial, Comparing the Safety and Efficacy of ActiGraftTM to Standard of Care inPatients With Chronic Neuropathic Diabetic FootUlcers

GBT: *

Protocol: GBT021601-021 A Phase 2/3 Randomized, Multicenter Study of GBT021601 Administered Orally to Participants with Sickle Cell Disease and an Open-Label Pharmacokinetics Study in Pediatric Participants with Sickle Cell Disease


GILEAD SCIENCES:


GS-US-528-9023 - A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children. Study to Assess the Effectiveness and Safety of Lenacapavir for Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PURPOSE 2) ClinicalTrials.gov Identifier: NCT04925752


GS-US-412-2055 - A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection (DISCOVER) ClinicalTrials.gov Identifier: NCT02842086

 

GS-US-412-2055 - A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection (DISCOVER) ClinicalTrials.gov Identifier: NCT02842086

 

GS-US-380-4030 - A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine /Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed ClinicalTrials.gov Identifier: NCT03110380

 

GS-US-380-4580 - A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants ClinicalTrials.gov Identifier: NCT03631732

 

GS-US-380-1844 - A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed ClinicalTrials.gov Identifier: NCT02603120

 

 GS-US-380-1961- A Phase 3, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Switching to a Fixed Dose Combination (FDC) of GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) From Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF), Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (E/C/F/TDF) or Atazanavir + Ritonavir + Emtricitabine/Tenofovir Disoproxil Fumarate (ATV+RTV+FTC/TDF) in Virologically Suppressed HIV-1 Infected Women ClinicalTrials.gov Identifier: NCT02652624

 

GS-US-380-1489 A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naive Adults ClinicalTrials.gov Identifier: NCT02607930

 

GS-US-380-1490- A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults ClinicalTrials.gov Identifier: NCT02607956

 

GS-US-366-1992 - A Phase 3b Randomized, Open-label, Controlled Study of the Efficacy, Safety and Tolerability of 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Subjects Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment, the HIV/HCV Co-STARs Study (Co-infection Treatment With Single Tablet Antiviral Regimens) ClinicalTrials.gov Identifier: NCT02707601

 

GS-US-380-1878- A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults ClinicalTrials.gov Identifier: NCT02603107

GS-US-311-1717- A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed on Regimens Containing ABC/3TC ClinicalTrials.gov Identifier: NCT02469246

 

GS-US-366-1216- A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) ClinicalTrials.gov Identifier: NCT02345252

 

GS-US-366-1160- A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/ Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Subjects ClinicalTrials.gov Identifier: NCT02345226

 

GS-US-311-1089- A Phase 3, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Positive Subjects Who Are Virologically Suppressed on Regimens Containing FTC/TDF ClinicalTrials.gov Identifier: NCT02121795

 

 GS-US-236-0102: QUAD A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Efavirenz/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment Naive Adults.

 

GS-US-236-0103: QUAD A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment Naive Adults

 

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

 

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 GS-US 292-0109: A Phse 3, Open Label Study to Evaluate Switching from a TDF containing Combination Regimen to a TAF Containing Combination Single Table regimen (STR) in Virologically suppressed, HIV 1 Positive Subjects.

 

GS-US-236-0114: QUAD A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir versus Ritonavir-Boosted Atazanavir Each Administered with /Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment Naive Adults.

 

GS-US-292-0117 A Phase 3, Two Part Study to Evaluate he Efficacy of tenofovir Alafenamide versus Placebo Added to a Falling Regimen Followed by Treatment with Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Positive. Antiretroviral Treatment Experienced Adults.

 

GS-US-292-0119 A Phase 3 Open-Label Study to Evaluate Switching from optimized Stable Antiretroviral Regimens Containing Daranavir to Elvitgravir/ Cobicistat/Emtricitabine/Tenofovir Alafenamide(E/C/F/TAF) Single Tablet regimen (STR) plus Daravir (DRV) in Treatment Experienced HIV-1 Positive Adults.

 

GS-US-164-0216 The SWIFT Study: A Prospective, Randomized, Open-Label Phase IV Study to Evaluate the Rationale of Switching from Fixed-Dose Abacavir (ABC)/Lamivudine (3TC) to Fixed-Dose Tenofovir DF (TDF)/Emtricitabine (FTC) in Virologically-Suppressed, HIV-1 Infected Patients Maintained on a Ritonavir-Boosted Protease Inhibitor-Containing Antiretroviral Regimen 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 Identifier NCT00708162

 

GS-US-311-1089/IND No:111,851: A Phase 3, Randomized, Open Label, Switch Study to Evaluate F/TAF in HIV-1 Positive Subjects who are Virologically Suppressed on Regimens containing FTC/TDF

 

GS-US-366-1160: A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching from a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/ Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Subjects.

 

GS-US-366-1216: A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Erntricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects who are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RP V/TDF)

 

GS-US-311-1717/ IND 111,851: A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in H1V-1 Infected Subjects who are Virologically Suppressed on Regimens containing ABC/3TC


GLAXO: GlaxoSmithKline / ViiV Healthcare

Protocol: GSK 204862 - A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Lamivudine in HIV-1 Infected Adults Who Are Virologically Suppressed (TANGO) Sponsor: ViiV Healthcare Collaborator: GlaxoSmithKline ClinicalTrials.gov Identifier: NCT03446573

Protocol:  LAI116482 (Latte) A Phase IIB, dose ranging study of oral GSK1265744 in combination with nucleoside reverse transcriptase inhibitors for induction of HIV-1 virologic suppression followed by an evaluation of maintenance of virologic suppression when oral GSK 1265744 is combined with oral rilpivirine in HIV-1 infected, antiretroviral therapy naive adult subjects.

Protocol: 11679 TH HIV-008 - A Phase randomized, observer-blind, placebo controlled, multicenter primary/booster therapeutic vaccination study to determine efficacy and safety of F4co/ AS01B vaccine, administered intramuscularly according to either a two dose (0, 4 weeks) or a three dose (0, 4, 28 weeks) schedule in ART-naïve HIV-1 infected persons aged 18-55 years Protocol Title (Study Name 114083 (TH HIV-011) Long-term follow up of participants from studies evaluating the HIV vaccine 732462

KOWA:
Protocol: NK-104-4.05US. A 12 week, randomized, Double Blind, Active-Controlled, Parallel-Group Study Comparing Pitavastatin 4md vs Pravastatin 40 mg in HIV infected Subjects with Dyslipidemia, followed by a 40-Week safety Extension Study.

MEDMIRA:


MCP002

MedM5779 – Rapid Diagnostic Tests - AptivAdvantage Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test for the Detection of HIV-1 Antibodies in Fingerstick and Venous Whole Blood Samples MRSA Study

MERCK:

MK-8591A - 018- A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV- 1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) ClinicalTrials.gov Identifier: NCT04925752

NAPO/SALIX

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)

NEOTRACT


Protocol: CP00014 I.M.P.A.C.T. Investigating Medication versus Prostatic Urethral Lift: Assessment and Comparison of Therapies for Benign Prostatic Hyperplasia NeoTract, Inc.

ONCOLOGY: 


GO40515 (20180638) - A Phase Ib/Ii, Open-Label, Multicenter, Randomized, Controlled Study Investigating The Safety,Tolerability, Pharmacokinetics, And Efficacy Of Mosunetuzumab (BTCT4465A) In Combination With CHOP Or CHPPolatuzumab Vedotin In Patients With B-Cell Non-Hodgkin Lymphoma

S1918 (20210957) - A Phase II/III Randomized Study of R-MiniCHOP With or Without CC-486 (Oral Azacitidine) inParticipants Age 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma, Transformed Lymphoma, and High-Grade B-Cell Lymphomas With MYC AND BCL2 and/or BCL6 Rearrangements

GSK204653 (20180040) - A phase I, open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK3326595 in subjects with solid tumors and non-Hodgkin’s lymphoma.

A51901 (20210950) - Phase I Trial of Methotrexate, Rituximab, Lenalidomide, and Nivolumab (Nivo-MR2) Induction Followed by Lenalidomide and Nivolumab Maintenance in Primary CNS Lymphoma

Duvelisib/Venetoclax (20191273) - A Phase I/II Study of Duvelisib and Venetoclax in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma or Patients With Richter's Syndrome

LOXO338 (20210481) - A Phase 1 Study of Oral LOXO-338, a Selective BCL-2 Inhibitor, in Patients with Advanced Hematologic Malignancies Pembro-ISRT (20190758) – Pembrolizumab and Involved Site Radiation Therapy for Early Stage Relapsed or Primary Refractory Hodgkin Lymphoma

AZD7789 (20220026) - A Phase I/II Open-label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, an anti-PD-1 and anti-TIM-3 Bispecific Antibody, in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma.


ORASURE:


Protocol: USURE US001
Protocol: USURE US002

OQ-OTC-5 SOLITAIRE

A Multi-Center, Actual Use Clincal Trial of the OraQuick ADVANCE® HIV 1/2 Antibody Test Over-the-Counter (OTC) Product Performance in Untrained Users; ProtocolOQ-HCV-WB-16-Clinical Investigation of the Suitability of the OraQuick Rapid HCV Antibody Test as a CLIA waived Test

REPROS THERAPEUTICS:

Protocol: ZA-300: An Open Label, Escalating Dose, 6 Month Phase III Safety Study of Enclomiphene Citrate in the Treatment of Men with Secondary Hypogonadism (NCT01534208)
Protocol: ZA-301 A Randomized, Double Blind, Placebo and Active Controlled, Dose Titration, Parallel, Multi-Center Phase lll Study to Evaluate Normalization of Morning Testosterone Levels in Younger (<60) Overweight (BMI>25) Men with Secondary Hypogonadism with Confirmed Morning Testosterone Levels 300ng/dL that wish to Preserve their Reproductive Status and are Not Currently being Treated with Topical Testosterone ZA301 Ext An Open Label, 6 Month Phase 1I1 Extension Study of Enclomiphene Citrate in the Treatment of Men with Secondary

Hypogonadism

Protocol: ZA-303: An Open Label, 12 Month, Single-Blind Placebo Controlled Phase III Study to Assess the Effects of Enclomiphene Citrate Treatment on Bone Density in Men with Secondary Hypogonadism (NCT 016119683)


ROCHE:

Protocol ROCHE RD2843

VISBY MEDICAL / CLICK DIAGNOSTICS:

Protocol: VISBY TP279:
Protocol: VISBY TP312:
Protocol: TP-000172:
Protocol: TP-000224:

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