NOT CURRENTLY RECRUITING
10-06-11
The purpose of this pilot study is to evaluate the efficacy and safety of FTC/RPV/TDF STR after switching from EFV/FTC/TDF at baseline in maintaining HIV-1 RNA < 50 copies/mL at week 12. HIV-infected patients who have been receiving EFV/FTC/TDF for greater than or equal to 3 months and are experiencing safety or tolerability concerns (in particular, efavirenz-related intolerance) may wish to change to an alternate, better tolerated regimen.
|
|
Clinical Trial
Basic Science/Virology
|
Pilot Assessment of Lopinavir/Ritonavir and Maraviroc in Experienced Patients
NCT00981318
|
Abbott,
Barry M. Rodwick, M. D.
Contact: Barry M. Rodwick, M. D. 727-725-9931 Doc@DrRodwick.com 727-725-9931 Doc@DrRodwick.com
Contact: Tiffany D. Ross, MA CRC 727-725-9931 Tiffany@DrRodwick.com 727-725-9931 Tiffany@DrRodwick.com
|
This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no nucleoside medications) in HIV patients failing their initial antiviral therapy.
|
|
Clinical Trial
|
Intensive Pharmacokinetic Studies of New Classes of Antiretroviral Drug Combinations in Children, Adolescents and Young Adults
NCT00977756
Contact: Patricia Bryan 305-243-4447 pbryan@med.miami.edu
Principal Investigator: Charles D. Mitchell, MD
Contact: Tammy A. Myers 813-259-8786 Tmyers@health.usf.edu
Contact: Zulma Eysallenne, R.N. 954-728-1125 Zeysallenne@browardhealth.org
|
Jennifer R. King, Pharm. D.,
U of A at Birmingham;
Ram Yogev, MD,
Northwestern University
Feinberg School of Medicine
International Maternal
Pediatric Adolescent AIDS
Clinical Trials Group
National Institute of Allergy
and Infectious Diseases (NIAID)
|
This study will examine drug and body interactions in children receiving anti-HIV treatment regimens using new medications. Drug regimens to be examined will feature the medications raltegravir (RAL), maraviroc (MVC), and etravirine (ETV). These drugs will not be provided through the study.
|
|
Clinical Trial
|
A Multicenter, Single Arm, Open-Label Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients
NCT01199939
|
Tibotec, Inc. Clinical Trial
Responsible Party: Vice President, Clinical Affairs, Tibotec, Inc
info1@veritasmedicine.com
|
This study is a Phase II single arm, open-label, multicenter, study of 50 human immunodeficiency virus-1 (HIV) infected adult patients, all of whom will receive etravirine (ETR) 400mg and DRV/r 800/100mg each given orally once daily. This trial is designed to evaluate the efficacy of the aforementioned ARV regimen, as measured by the percentage of patients with HIV RNA <50 copies/mL at 48 weeks, in early treatment-experienced HIV-infected patients. In addition to general safety parameter measurements, this trial will also assess changes in metabolic, inflammatory, immune restoration, and bone markers. Screening will occur over a 6-week period. The primary endpoint will be assessed at Week 48, and the treatment period is 48 weeks. The end of study endpoint will be met by either completing the Week 48 visit, or by early termination from the study for any reason.
|
|
Clinical Trial
|
A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects With Dyslipidemia, Followed by a 40-Week Safety Extension Study
NCT01301066
|
Kowa Research Institute, Inc.
Roger E Morgan, MD, FACS
Contact: Roger E Morgan, MD, FACS 919-433-1600 RMorgan@KowaUS.com
|
A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
|
|
Clinical Trial
Basic Science/Virology
|
Safety and Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A in Adult HIV-infected Subjects
NCT01165203
|
Contact: US GSK Clinical Trials Call Center 877-379-3718
GSKClinicalSupportHD@gsk.com
|
This observer-blind study will evaluate the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational Herpes Zoster (HZ) vaccine GSK1437173A in Human Immunodeficiency Virus (HIV) infected subjects, firstly enrolling subjects treated with antiretroviral therapy (ART) and with high CD4 T cell counts, and subsequently ART-treated subjects with low CD4 T cell counts, and ART-naïve subjects with high CD4 T cell counts. This Protocol Posting has been updated following Amendment 1 of the Protocol, August 2010. The impacted section is exclusion criteria.
|
|
Clinical Trial
Behavioral/Epidemiological
|
Maraviroc Plus Darunavir/Ritonavir Study for Treatment-Naïve Patients Infected With R5-tropic HIV-1 Based on Enhanced Sensitivity Trofile
NCT00993148
|
Principal Investigator: Jose Castro, M.D. (U of Miami);
Babafemi Taiwo, MD, Northwestern University
Pfizer
Tibotec, Inc
This study is ongoing, but not recruiting participants
10-06-11
Babafemi Taiwo, MD, Northwestern University (no contact information provided)
|
The objective of this study is to evaluate the safety and efficacy of a novel combination antiretroviral therapy regimen consisting of maraviroc plus darunavir/ritonavir in treatment-naive patients infected with R5-tropic HIV-1. The hypothesis is that in treatment-naive subjects infected with R5-tropic HIV-1, combination antiretroviral therapy with maraviroc plus darunavir/ritonavir is well tolerated and efficacious.
|
|
Clinical Trial
|
An Observer- and Subject-Blinded, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intramuscular and Subcutaneous Long Acting GSK1265744 in Healthy Subjects
NCT01215006
|
GSK Investigational Site, Daytona Beach, Florida
VIIV Healthcare – Study Sponsor
This study is ongoing, but not recruiting participants.
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure (no contact information given)
|
A single dose escalation study to determine the safety, tolerability, and pharmacokinetic profile of intramuscular and subcutaneous injections of GSK1265744 long acting parenteral (LAP) in healthy subjects. This study consists of a screening visit, a single injection, and follow-up evaluations for a minimum of 12 weeks following the injection.
|
|
Clinical Trial
Behavioral/Epidemiological
|
A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging
NCT00822120
|
M.D. Anderson Canter Center at Orlando
Recruiting
Orlando, FL
M.D. Anderson Cancer Center at Orlando, Florida, United States, 32806
Contact: Julio J. Hajdenberg, MD 321-841-7219
Contact: Julio J. Hajdenberg, M.D.
321-841-7219
Southwest Oncology Group National Cancer Institute (NCI)
|
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. G-CSF may help lessen the side effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F 18-PET/CT imaging, may help doctors predict how patients will respond to treatment.
PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing response to combination chemotherapy and allow doctors to plan better additional further treatment in treating patients with stage III or stage IV Hodgkin lymphoma.
|
|
Clinical Trial
|
A Randomized, Double Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial of An Investigational Medication VS. Placebo in The Treatment of Neuropathic Pain Associated With HIV Neuropathy
|
Email: cahlstrom@southfloridamedicalresearch.com
Cheryl Ahlstrom, Patient Liaison/Recruitment
South Florida Medical Research
21150 Biscayne Blvd , Suite 300
Aventura, FL 33180
Phone: 305-931-8080
Fax: 305-931-8088
|
The study is being done to find out the good and bad effects of an investigational drug that is not approved for sale to treat peripheral neuropathic pain associated with HIV. The purpose is to see if the study drug relieves peripheral neuropathic pain associated with HIV. The study will also evaluate any side effects and whether or not they might be related to the study drug. Lastly, the study will assess whether patients will experience improvement in sleep , general health, and on symptoms of anxiety and depression. There will be about 422 people in this study. You will be in the study for about 127 days.
|
|
Clinical Trial
|
HIV-Neuropathy Study- Phase three trial which lasts for 5 months with 12 visits for patients who suffer from neuropathic pain associated with HIV.
Phase 3B, randomized, double-blind, placebo-controlled, parallel group, study of drug vs. a placebo in the treatment of neuropathic pain associated with HIV-1 infection. It is a 5 month, 12 visit study to compare the effects of the study medication to placebo.
|
Email:cahlstrom@southfloridamedicalresearch.com
Cheryl Ahlstrom, Patient Liaison
South Florida Medical Research
21150 Biscayne Blvd, Suite 300
Aventura, FL 33180
Phone: 305-931-8080
Fax: 305-931-8088
|
Men or women 18 years or older with documented evidence of HIV-1 infection who have distal symmetrical polyneuropathy with subjective sensory symptom of pain. (physician rated)
Pain started in the feet
Must have moderate to severe neuropathy symptoms in the feet for at least 3 months due to HIV neuropathy
Pain is constant every day
HIV treatment is stable
|
|
Clinical Trial
Behavioral/Epidemiological
|
An International Observational Study to Characterize Adults Who Are Hospitalized With Complications of Influenza A – Pandemic H1N1 (H1N1v); NCT01056185
|
University of Minnesota – Clinical and Translational Science Institute
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Infectious Diseases Associates NW FL, PA
Pensacola, Florida, United States, 32504
Contact: Barbara He Wade, MD, FACP
-
bwade@infectioncenter.com
Principal Investigator: Barbara He Wade, MD, FACP
|
The “flu” is a common disease and usually mild, but severe disease and death may occur. There are several types of flu viruses and they change over time. Recently, a new influenza A virus known commonly as swine flu or H1N1v has emerged. This flu has spread rapidly around the world. It is important to understand the course of illness for those who have H1N1v and the characteristics of people who do not do well. The investigators will also try to learn more about how different treatments and prior vaccination for the flu affects the course of the illness. Approximately 1,000 individuals will be enrolled in several countries around the world. The results of this study will be used to advise on the management of patients who are hospitalized with the flu.
|
|
Clinical Trial
Behavioral/Epidemiological
|
INSIGHT H1N1v Outpatient Study (FLU 002)
Official Title: An International Observational Study to Characterize Adults With Influenza A – Pandemic H1N1 (H1N1v); NCT01056354
|
University of Minnesota - Clinical and Translational Science Institute;
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH) Infectious Diseases Associates NW FL, PA
Not yet recruiting
Pensacola, FL
P.I.: Barbara Wade, M.D.
Contact Barbara Wade, MD
850-476-3131
bwade@infectioncenter.com
|
The "flu" is a common disease and usually mild but severe disease and deaths may occur. There are several types of flu viruses and they change over time. Recently, a new influenza A virus known commonly as swine flu or H1N1v has emerged. This flu has spread rapidly around the world. It is important to understand the course of illness for those who have H1N1v and the characteristics of people who do not do well. The investigators will also try to learn more about how different treatments and prior vaccination for the flu affect the course of the illness. Approximately 5,000 individuals with swine flu will be enrolled in several countries around the world.
|
|
Clinical Trial
|
A Blinded, Randomized, Placebo-controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-450 With Ritonavir (ABT-450/r), ABT-333 or ABT-072 Each Administered Alone and in Combination With Peginterferon α-2a and Ribavirin (PegIFN/RBV) in Treatment- Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
NCT01074008
|
ABBOTT Contact: Christian Naylor
(847) 935-2492
christian.naylor@abbott.com
Contact: Victoria M Mullally
847-935-1406
tori.mullally@abbott.com
Orlando area
|
A 12-week study of combination direct-acting antiviral agent (DAA) and pegIFN/RBV in subjects with chronic HCV.
|
|
Clinical Trial
|
A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection
NCT01220947
|
Hoffmann-La Roche
Recruiting Orlando and South Miami, FL
Study ID #: NV22776
888-662-6728 (U.S. only)
Genentechclinicaltrials@druginfo.com
|
This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C
|
|
Clinical Trial
Behavioral/Epidemiological
|
Isotretinoin With or Without Monoclonal Antibody, Interleukin-2, and Sargramostim Following Stem Cell Transplantation in Treating Patients With Neuroblastoma
Official Title: Phase III Randomized Study Of Chimeric Antibody 14.18 (CH14.18) In High Risk Neuroblastoma Following Myeloablative Therapy And Autologous Stem Cell Rescue
NCT00026312
|
Numerous locations throughout Florida
Children's OncologyGroup; National Cancer
Institute (NCI)
Under 30 yrs old
Study Chair:
Alice L. Yu, M.D., Ph.D.
UC at San Diego (no contact information provided)
Gregory H. Reaman, Children's Oncology Group - Group Chair Office
|
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without monoclonal antibody therapy, interleukin-2, and sargramostim following stem cell transplantation in treating neuroblastoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without monoclonal antibody, interleukin-2, and sargramostim following stem cell transplantation in treating patients who have neuroblastoma
|
|
Clinical Trial
|
Study on The Combination of RO5024048 And Ritonavir-Boosted Danoprevir With And Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)
Official Title: INFORM-SVR: A Randomized, Multi-Center Study of Interferon-Free Treatment With a Combination of a Polymerase Inhibitor (RO5024048) and a Ritonavir Boosted HCV Protease Inhibitor (RO5190591/r, DNV/r) With or Without Copegus® in Interferon Naïve HCV Genotype 1 Infected Patients
NCT01278134
|
HOFFMAN-LA ROCHE
Will be recruiting in Orlando, FL
Please reference Study
ID # PP25213
888-662-6728
genentechclinicaltrials@druginfo.com
|
This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1 who are treatment-naïve for interferons. Patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response, the assigned treatment will be continued for a further 12 weeks. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up
|
Community AIDS Network, Sarasota, FL
Tanya Schreibman, M.D., Medical Director
|
Clinical Trial
|
Title: A pilot randomized, open-label study comparing the safety and efficacy of a Raltegravir based NRTI sparing regimens "No Nukes Study".
|
Site Investigator: Tanya Schreibman, M.D. (PI is Yale based: Michael Kozal, MD)
Community AIDS Network
941-366-0134
|
Study primary site is Yale University with our site (Community AIDS Network/Comprehensive Care Clinic) as a satellite site
|
HIV, antiretroviral therapy
|
Orlando immunology center, orlando, FL
Edwin Dejesus, M.D., medical Director
|
Clinical Trial
|
Title: Evolution of L74V or K65R Mutations in Vlremic Subjects on TDF or ABC (EVITA)
|
Study Director: Edwin Dejesus, MD, FACP
(407) 647-3960
|
This is a multicenter, open-label, non-randomized, dual-arm pilot study to investigate the prevalence of the reverse transcriptase (RT) resistance mutations, K65R/x or L74V/x, in HIV-1 plasma from subjects experiencing confirmed first-time incomplete virologic suppression during treatment with an initial antiretroviral (ARV) regimen consisting of at least 12 weeks of TDF or ABC + emtricitabine (FTC) or lamivudine (3TC) + non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Subjects will be followed until a substantial loss of virologic or immunologic control requires a treatment switch. Confirmed first-time incomplete virologic suppression is defined as an initial plasma HIV-1 RNA response < 400 copies/mL, and subsequent virologic rebound > 400 copies/mL measured at two consecutive times.
Subjects will have a screening genotype to establish adherence to their non-suppressive TDF- or ABC-containing regimen by the presence of M184V (or other treatment-related primary) mutation and to demonstrate that the evolution of treatment-emergent RT mutations can be characterized.
Twenty subjects (a maximum of 10 per arm) will be enrolled at 10-20 United States (U.S.) sites. If fewer than 20 subjects can be enrolled, the study may be discontinued early by the sponsor. Equal numbers of subjects on Arm A versus Arm B will be a goal.
|
|
Yüklə 1.25 Mb.