Florida Clinical
Trials By City

Fort Pierce Florida Clinical Trials

A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)
This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in HIV-1 infected, ART-naïve [more...]  women over 48 weeks. This study will also characterize the safety and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC. Sufficient number of subjects will be screened in order to ensure a total of approximately 474 subjects will be randomized (237 in each study arm)
Status: Recruiting Start Date: August 2013 Completion Date: March 2018
Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
The primary objective of this study is to evaluate the effect of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) on renal parameters at Week 24. To measure the proportion of subjects achieving virologic response of HIV-1 RNA < [more...]  50 copies/mL.
Status: Recruiting Start Date: March 2013 Completion Date: December 2015
Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects
The purpose of this study is to evaluate the non-inferiority of switching to a TAF-Containing Combination single tablet regimen (STR) relative to maintaining TDF-containing combination regimens in virologically-suppressed HIV-1 positive subjects as determined by having HIV-1 RNA < 50 [more...]  copies/mL at Week 48 following the switch.
Status: Recruiting Start Date: March 2013 Completion Date: July 2015
Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults
The purpose of this study is to evaluate the efficacy of a single-tablet regimen (STR)containing elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus a STR containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment naïve adult subjects as determined [more...]  by the achievement of HIV-1 RNA < 50 copies/mL at Week 48
Status: Recruiting Start Date: February 2013 Completion Date: September 2015
Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults
The purpose of this study is to evaluate the efficacy of a single-tablet regimen (STR)containing elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus a STR containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment naïve adult subjects as determined [more...]  by the achievement of HIV-1 RNA < 50 copies/mL at Week 48.
Status: Recruiting Start Date: December 2012 Completion Date: August 2015
A Follow up Study Designed to Obtain Long Term Data on Subjects Who Either Achieved a Sustained Virologic Response or or Did Not Achieve a Sustained Virologic Response in an Abbott Sponsored Hepatitis C Study
A follow up study designed to obtain long term data on subjects who either achieved a sustained virologic response or did not achieve a sustained virologic response in an Abbott sponsored hepatitis C study.
Status: Recruiting Start Date: June 2013 Completion Date: May 2016
Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women
To evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate in HIV-1 infected, antiretroviral treatment-naïve adult women as determined by the achievement of HIV 1 RNA <50 [more...]  copies/mL at Week 48
Status: Recruiting Start Date: October 2012 Completion Date: March 2016
A Dose-Ranging Study to Compare MK-1439 Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007 AM9)
Part 1 - Dose-Ranging. Part 1 will evaluate the (1) safety and tolerability and (2) efficacy (antiretroviral activity) of 4 doses of MK-1439 compared with efavirenz, when each is given in combination with TRUVADA® for at least 24 weeks in approximately 200 participants. A [more...]  single dose of MK-1439 will be selected for further study after all participants complete the Week 24 visit in Part 1. Participants receiving any dose of MK-1439 in Part 1 will be switched to the selected MK-1439 dose and continue in the study for up to 96 weeks. Part 2 - Selected Dose. Part 2 will be initiated after the MK-1439 dose has been selected as indicated above for Part 1. Approximately 120 additional participants will be randomized in 1:1 ratio to the selected dose of MK-1439 or efavirenz, each in combination with TRUVADA® for 96 weeks of blinded treatment. Part 2 will evaluate the safety of the selected dose compared with efavirenz, particularly with regard to central nervous system adverse events (CNS events). The hypothesis tested in this study is that MK-1439 at the final dose selected is superior to efavirenz, each given in combination with TRUVADA®, as measured by the proportion of participants with CNS events by Week 8. If superiority is established at Week 8, the same hypothesis will be tested for Week 24.
Status: Recruiting Start Date: October 2012 Completion Date: March 2016
A Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea
608 patients with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study and receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will last for 10 days and participants will be followed up for at least 40 days and a maximum [more...]  of 100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as compared to vancomycin.
Status: Recruiting Start Date: May 2012 Completion Date: December 2014
Phase 3b Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
The purpose of this study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naïve and -experienced adult subjects with no Darunavir (DRV) resistance-associated [more...]  mutations.
Status: Recruiting Start Date: September 2011 Completion Date: May 2013
Prospective Observational Epidemiologic Study of Maraviroc's Safety
The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.
Status: Recruiting Start Date: March 2008 Completion Date: October 2018
A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study
A study to evaluate the safety and effect of treatment with experimental antiviral drugs in combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who did not respond to treatment in a previous AbbVie/Abbott combination study.
Status: Enrolling by invitation Start Date: December 2012 Completion Date: June 2017
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection
This is a study to evaluate chronic hepatitis C infection in adults with genotype 1a infection.
Status: Active, not recruiting Start Date: March 2013 Completion Date: November 2014
IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1
The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.
Status: Active, not recruiting Start Date: December 2012 Completion Date: October 2015
A Study to Evaluate Chronic Hepatitis C Infection
A study to evaluate chronic hepatitis C infection.
Status: Active, not recruiting Start Date: November 2012 Completion Date: September 2014
Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine
The study is designed to select a dose of GSK1265744 primarily on the basis of antiviral activity and tolerability in HIV-1 infected, antiretroviral naive subjects. This study consists of two parts: Induction Phase: Approximately 200 subjects will be randomized [more...]  (50 subjects in each of the 4 treatment arms). The Induction Phase consists of a 24 week dose-ranging evaluation of GSK1265744 at blinded doses of 10 mg, 30 mg and 60 mg once-daily and a control arm of open-label efavirenz (EFV) 600 mg once daily. The background dual nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral therapy (ART) for all arms will be either abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) as selected by the Investigator. Subjects randomized to a GSK1265744 containing arm, who successfully complete 24 weeks on study and demonstrate virologic suppression (defined as having a plasma HIV-1 ribonucleic acid [RNA] <50 copies per milliliter [c/mL] before Week 24, with no signs of virologic rebound) will become eligible for the Maintenance Phase of this study. Maintenance Phase: The background NRTIs will be discontinued and the subjects will continue their randomized dose of GSK1265744 in combination with rilpivirine (RPV) 25 mg once-daily for an additional 72 weeks. The Maintenance phase will evaluate the ability of this two drug ART regimen to maintain virologic suppression through Week 48, Week 72 and Week 96. Subjects randomized to the EFV arm will continue on their randomized regimen through Week 96. After completion of the maintenance phase, subjects could enroll in the Open-Label Phase to continue GSK1265744 + RPV treatment as long as they continue to derive clinical benefit and until it is locally approved and commercially available.
Status: Active, not recruiting Start Date: August 2012 Completion Date: December 2016
Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir
Study ING116529 is a multicenter, randomized, study with an initial 7 day placebo- controlled, functional monotherapy phase to quantify the antiviral activity attributable to dolutegravir (DTG) in HIV-1 infected, ART-experienced adults who are experiencing virological failure on an Integrase [more...]  inhibitor containing regimen (current RAL or ELV failures), with evidence of genotypic resistance to RAL or ELV at study entry. Thirty subjects will be randomized (1:1) to receive either DTG 50mg BID (Arm A) or Placebo (Arm B) with the current failing regimen for 7 days (RAL or ELV should be discontinued prior to dosing with DTG). At Day 8, subjects from both arms will enter an open label phase and receive open label DTG 50mg BID with an optimized background regimen containing at least one fully active drug.
Status: Active, not recruiting Start Date: April 2012 Completion Date: June 2015
Phase 3b Open Label Study to Evaluate Switching From Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV 1 Infected Patients
The purpose of this study is to evaluate the non-inferiority of Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) relative to regimens consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) plus Emtricitabine and Tenofovir DF (FTC/TDF) in maintaining HIV 1 [more...]  RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV 1 infected subjects.
Status: Active, not recruiting Start Date: November 2011 Completion Date: December 2014
Phase 3b Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV 1 Infected Patients
To evaluate the non-inferiority of Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI/r) plus Emtricitabine/Tenofovir Fixed-Dose Combination (FTC/TDF, Truvada) in maintaining HIV 1 RNA < 50 copies/mL at Week [more...]  48 in virologically suppressed, HIV 1 infected subjects.
Status: Active, not recruiting Start Date: November 2011 Completion Date: December 2014
Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment
The purpose of this study is to characterize the effect of Cobicistat based regimens on parameters of renal function in HIV infected patients with mild to moderate renal impairment, and also, to assess the safety and tolerability of those regimens in order to [more...]  generate appropriate dosing recommendations.
Status: Active, not recruiting Start Date: May 2011 Completion Date: March 2014
A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.
The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with current or historical failure on an integrase inhibitor (INI) containing regimen. The [more...]  study will assess DTG 50mg twice daily administered initially with the current failing ART regimen but then with an optimised background ART regimen (OBR) after Day 7. The first analyses will be conducted after the last subject enrolled has completed 24 weeks. Subjects may remain on study after Week 24.
Status: Active, not recruiting Start Date: May 2011 Completion Date: January 2016
Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults.
The purpose of the study is to evaluate the safety and efficacy of a single tablet regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate compared with a single tablet regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV 1 Infected, Antiretroviral Treatment-Naïve Adults. [more...]  The FTC/RPV/TDF single tablet regimen could offer an alternative treatment option to patients who wish to simplify or improve the tolerability of their treatment but want to avoid using efavirenz due to concerns about central nervous system side effects, rash, elevations in plasma lipids as well as to women of childbearing potential.
Status: Active, not recruiting Start Date: February 2011 Completion Date: July 2013
A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48 weeks; non-inferiority [more...]  will also be tested at Week 96. This study will be conducted in HIV-1 infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and development of viral resistance will be evaluated.
Status: Active, not recruiting Start Date: February 2011 Completion Date: March 2015
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF
The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study was to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens consisting of [more...]  a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment. Participants were randomized into 2 groups, the FTC/RPV/TDF STR group, in which participants switched treatment regimens at the start of the study, and the Stay on Baseline Regimen group, in which participants remained on their baseline regimen during the first 24 weeks of the study (designed to provide an initial active control), and may have switched to the FTC/RPV/TDF STR at the Week 24 visit. After the 48-week study analysis period, participants may have continued to receive the FTC/RPV/TDF STR per protocol before switching to a commercially available source.
Status: Active, not recruiting Start Date: November 2010 Completion Date: December 2013
A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults
ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 [more...]  mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an investigator selected background regimen consisting of at least one fully active agent plus no more than one second single agent which may or may not be active. Antiviral activity, safety, pharmacokinetics (PK), and development of viral resistance will be evaluated.
Status: Active, not recruiting Start Date: October 2010 Completion Date: November 2015
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Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Participants often receive the best healthcare available for their condition.

Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. Trials are federally regulated with strict guidelines to protect participants.

Fort Pierce Florida Clinical Trials Information presented on ClinicalTrialsSearch.org is not intended to be a substitute for qualified medical advice visit or treatment with a real physician. We are not physicians. Always consult with a medical doctor (MD). ClinicalTrialsSearch.org is a website dedicated to listing clinical research studies in human subjects, including those specifically related to Fort Pierce Florida. Clinical research trials and medical trials take place in hundreds of cities across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectiveness of new treatments and drugs. The purpose of the studies is to answer specific human health questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions. Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Many times the participants receive treatment for free, and sometimes they are paid for their time. Participants often receive the best healthcare available possible for their condition. Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. U.S. - based Fort Pierce Florida studies are federally regulated with strict guidelines to protect patients.

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