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Treatment Naïve or Treatment Experiences and Virologically Failing

Donna Mildvan, MD, Chief, Division of Infectious Disease
Beth Israel Medical Center

GS-US-216-0130: A Phase 3b, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Cobicistat-boosted Darunavir Plus Two Fully Active Nucleoside Reverse Transcriptase Inhibitors in HIV 1 Infected, Antiretroviral Treatment-Naïve and -Experienced Adults With No Darunavir Resistance-associated Mutations

Treatment Naïve: No prior use of any approved or investigational antiretroviral drug for any length of time OR
Treatment Experienced: Stable antiretroviral regimen for at least 12 weeks prior to screening
Plasma HIV 1 RNA levels ≥ 1000 copies/mL at screening
Screening genotype report shows full sensitivity to two nucleoside analogue reverse transcriptase inhibitors (NRTIs) and no darunavir resistance associated mutations
No previous or current use of darunavir

Study Arm - Cobicistat boosted darunavir (cobicistat 150 mg tablet with food daily for 48 weeks)

Study Location: Beth Israel Medical Center, AIDS Clinical Trials Unit, 350 East 17th Street, 3rd Floor, New York, NY 10003
Contact Information: (212) 420-4519 or 800-483-7339
Email: Trials@BethIsraelNY-HIVtrials.org

Cetuximab With or Without Chemotherapy

Dr. Zujun Li
Beth Israel Medical Center, West Side Campus, 325 West 15th Street, New York, NY 10011

Randomized, Open-Label, Stratified Phase 2 Trial of Gemcitabine, Carboplatin, an dCetuximab With Vs. Without IMC-A12 in Chemotherapy-Naïve Patients with Advanced/Metastatic Non-Small Cell Lung Cancer.

The main purpose of this study is to see if adding cixutumumab to a regimen of cetuximab and chemotherapy is more effective than cetuximab and chemotherapy alone. This study will evaluate the effects of cixutumumab and cetuximab (good or bad) on the body and test how long these drugs remain in the blood and how the body rids these drugs from its system. This study will investigate the growth or spread of lung cancer by measuring the size of tumors to see if they have decreased in size or increased in size or disappeared. The study will also look at what side effects subjects may have and how subjects feel when receiving study drugs.

Several criteria must be met to be eligible for this study, including but not limited to the following:

- Stage IIIb – IV non-small cell lung cancer
- No prior chemotherapy unless adjuvant chemotherapy that was given over 6 months ago
- Adequate cardiac, liver and kidney function
- Age 18 or older

For more information or to see if you are eligible for this study, please contact: Zujun Li, MD at (212)604-6013

START – Stimulating Targeted Antigenic Responses to NSCLC

Dr. Zujun Li
Beth Israel Medical Center, West Side Campus, 325 West 15th Street, New York, NY 10011

A multi-center phase III randomized, double-blind placebo-controlled study of the cancer vaccine Stimuvax® (L-BLP25 or BLP25 liposome vaccine) in non-small cell lung cancer (NSCLC) subjects with unresectable stage III disease. The purpose of this research study is to find out whether taking a new cancer drug called Stimuvax (or L-BLP25 or BLP25 liposome vaccine) in addition to best supportive care can extend your life and provide you with a good quality of life.

We hope to learn what effects Stimuvax has on you and your type of cancer. The purposes of this study are to look at the effect of Stimuvax on survival, determine the safety of Stimuvax for people with lung cancer and find out how Stimuvax affects the quality of life

Several criteria must be met to be eligible for this study, including but not limited to the following:

- Unresectable stage III non-small cell lung cancer
- Previous chemotherapy and radiation therapy
- Adequate cardiac, lung, liver and kidney function
- Age 18 or older

Contact: Zujun Li, MD at (212) 604-6013

Weight Loss & Bariatric Surgery

Dr. Allan Geliebter, Senior Research Scientist
St. Luke’s and Columbia University Medical Center

Bariatric fMRI study: The purpose of this study is to asses the biological changes created by weight loss. In order to do this, subjects from two groups are compared: patients receiving bariatric surgery and patients losing weight in our free weight loss program. Non-surgery participants who are eligible are enrolled in a three month long weight loss program which entails a diet and free weekly sessions with a clinical nutritionist.

We are currently seeking overweight men and women between the ages of 18 and 65. Interested participants are asked to come in for a physical exam, an initial consult and three sessions involving blood draws and MRI scans over the span of 18 months. Once enrolled, subjects receive free weight loss coaching, travel compensation, and time commitment compensation of up to $850.

If interested please call (212) 523-1713 or e-mail bariatric.fmri@gmail.com

Women’s Sleep Clinical Trial

Dr. Marie-Pierre St. Onge
St. Luke’s & Roosevelt Hospitals

Are you a good sleeper? If you are:

» Female

» Age 30-45

» Slightly overweight

» Non-diabetic

» Healthy

» Weight stable

And sleep 7-8.5 hours per night, then you may qualify to participate in our Sleep Study!

Contact: Benjamin Renauld (212) 523-1602 or nihsleepstudy@gmail.com

Stool Transplant Study

Dr. Donald Kotler, Chief, Division of Gastroenterology and Liver Disease
Dr. Ellen Engleson, Associate Director for Research and Nutrition, Division of Gastroenterology
St. Luke’s & Roosevelt Hospitals

The stool transplant study is for people who have recurrent Clostridium difficile (c-Diff) associated with diarrhea. Most people respond to treatment with antibiotics on the first occurrence of CDAD, but others go on to have it again and again. Part of the problem is that the antibiotics kill not only the c-Diff, but also the “good bacteria” in the gut, which allows any spores of c-Diff remaining after antibiotic treatment to germinate in the colon. Fecal transplants from healthy individuals have been shown in case series to repopulate the gut with a healthy balance of flora, which produces a cure for CDAD. So far we have treated one patient successfully.

Management of prostate cancer in HIV-positive patients

Dr. Franklin Lowe, Associate Director of Urology
St. Luke’s & Roosevelt Hospitals
Study by Matthew S. Wosnitzer & Franklin C. Lowe

Improved medical therapy for HIV-positive patients has helped delay the progression of HIV to AIDS and reduce AIDS deaths. This dramatically prolonged survival has resulted in increased detection of non-AIDS-defining malignancies, such as prostate cancer, in people with HIV. Treatment options for HIV-positive patients with prostate caner should include all those offered to the general population. Long-term treatment outcomes in HIV-positive patients remain uncertain; however, early results suggest response rates similar to those in HIV-negative patients.

Nutrition and Obesity Study

Dr. Marie-Pierre St. Onge
St. Luke’s & Roosevelt Hospitals
New York Obesity Research Center Clinical Researcher

We are looking for 7 to 9 year-old children to participate in a healthy eating study! Children will participate in nutrition lessons and learn about healthy foods and eating habits. If your child does not eat breakfast every day, he or she may qualify! Compensation provided up to $240 + up to $60 gift cards for your child.

Contact: Louis Bergstrom (212) 523-3561 or stoplightdietstudy@gmail.com

Effect of Droxidopa on Neurogenic Orthostatic Hypotension (NOH) in Patients with Parkinson’s Disease

Dr. William L. Severt, Attending, Department of Neurology
Beth Israel Medical Center

This multi-center, double-blind, randomized, placebo-controlled study to assess the clinical effect of droxidopa in the treatment of symptomatic neurogenic orthostatic hypotension in patients with PD. The study will evaluate the clinical benefit in NOH patients with Parkinson’s disease treated with droxidopa compared to those treated with placebo.

Contact: Rabih Kashouty, MD, at (212) 844-6571 or Dr. Severt at LSevert@chpnet.org

Growth Factors and Parkinson’s Disease

Dr. William L. Severt, Attending, Department of Neurology
Beth Israel Medical Center

This clinical trial is open for patients with Parkinson’s disease who develop symptoms that are not responding well to current therapies. CERE-120 is an experimental drug that contains the human gene for a growth factor called neurturin. CERE-120 has been shown to be safe in animals and in people with PD, and it has been shown to protect and improve the function of damaged brain cells. CERE-120 has the potential to improve PD symptoms and possibly slow disease progression. Participants may be assigned to receive the experimental gene therapy by the neurosurgeon injecting it directly into areas of the brain that are affected by Parkinson’s disease, or a placebo (sham surgery). This research study is sponsored by Ceregene.

Contact: Rabih Kashouty,MD, at (212) 844-6571,or Dr. Severt at LSevert@chpnet.org

Neuroimaging and Metabolomics Correlates of Cognitive Decline in Parkinson’s Disease (PD)

Dr. William L. Severt, Attending, Department of Neurology
Beth Israel Medical Center

This study, in collaboration with Weill Cornell Medical College, is being done to examine the course of cognitive decline in PD over time, and is sponsored by the National Institutes of Health.

Contact: Rabih Kashouty,MD, at (212) 844-6571, or Dr. Severt at LSevert@chpnet.org

Neuroimaging Studies in Parkinson’s Disease and Dystonia

Dr. Susan B. Bressman, Chairman of the Mirken Department of Neurology and Division Chief of Movement Disorders
Beth Israel Medical Center

Neuroimaging is a unique and cutting-edge way to learn how the brain works. To explore whether this technology can help us to identify people at risk for Parkinson’s disease before symptoms start and when intervention may still be possible, we are seeking to study 60 first-degree relatives of PD patients with fMRI/DAT scanning at St. Luke’s Hospital. We are thrilled to be collaborating on this project with Dr. Gordon DePuey (St. Luke’s Hospital) and Dr. Kenneth Marek (Institute for Neurodegenerative Diseases). We also continue to recruit subjects with both PD and dystonia for PET scanning studies with our long-term collaborator, Dr. David Eidelberg at North Shore Hospital. The Principal Investigator is Dr. Susan B. Bressman.

Contact: Akhila Iyer or Deborah Raymond at aiyer@chpnet.org, (212) 844-6053 or toll-free at (888) 228-1688

Dystonia Genetic Study

Dr. Susan B. Bressman, Chairman of the Mirken Department of Neurology and Division Chief of Movement Disorders
Beth Israel Medical Center

Last year the Parkinson’s Disease and Movement Disorders Research Center at Beth Israel became the first ever Dystonia Center of Excellence through a grant from the Bachmann-Strauss Dystonia & Parkinson Foundation. An important component of the Center of Excellence is research. Together with Dr. Laurie Ozelius at The Mount Sinai Medical Center and other collaborators, we have made great strides, including identifying a number of dystonia genes (DYT1, DYT6 and DYT12). There is still a great deal of work to be done. We are seeking dystonia patients to participate in genetic studies. Participation involves filling out paperwork and giving a blood sample. The Principal Investigator is Dr. Susan B. Bressman.

Contact: Akhila Iyer or Deborah Raymond at aiyer@chpnet.org, (212) 844-6053 or toll-free at (888) 228-1688

Parkinson’s Genetics in Ashkenazi Jews

Dr. Susan B. Bressman, Chairman of the Mirken Department of Neurology and Division Chief of Movement Disorders and Dr. Saunders-Pullman, Attending Neurologist
Beth Israel Medical Center

The Parkinson’s Disease and Movement Disorders Research Center at Beth Israel is in its second year of a three-year study of the genetics of Parkinson’s disease (PD) in collaboration with Columbia University and Tel Aviv Sourasky Medical Center. The project, which is funded by the Michael J. Fox Foundation for Parkinson’s Research, involves 2,000 Ashkenazi (Eastern European) Jewish PD patients from the three centers. It is focused on characterizing the clinical and pre-clinical features of PD due to the LRRK2 gene, as well as factors that influence or modify how the gene expresses itself (for example, some people with the gene develop PD in their 30s and some remain symptom-free for life). An additional aim of the study is to identify new genes that contribute to PD. Our site is funded by the Marcled Foundation to evaluate the role of other known PD genes in Ashkenazim.

Participation takes about one hour and involves answering questions and giving a blood sample. A subset of subjects and their first-degree relatives will be invited to participate in a more in-depth examination that takes about four hours, but can be split over two or more visits or completed in part over the phone.

We also need to study Ashkenazi Jewish spouses and spouses of children of PD patients. In order to have comparison groups, we are seeking people without PD who would be willing to fill out questionnaires, and undergo spiral drawing, smelling, memory and ultrasound tests.

Dr. Susan B. Bressman is the Principal Investigator of the Michael J. Fox Foundation for Parkinson’s Research study. Dr. Saunders-Pullman is the Principal Investigator for the supplemental biomarkers study and the Marcled Foundation Study. In addition, Drs. Vicki Shanker, Lawrence Severt, Matthew Barrett, José Cabassa, Mark Groves and Christina Palmese, and Deborah Raymond are actively involved.

Contact: Akhila Iyer or Deborah Raymond at aiyer@chpnet.org, (212) 844-6053 or toll-free at (888) 228-1688

POEM Study

Dr. Jose Fefer, Attending Physician, Center for Comprehensive Care
Dr. Victoria Sharp, Director, Center for Comprehensive Care
St. Luke’s and Roosevelt Hospital Center’s Center for Comprehensive Care (CCC)

The POEM study (Prospective Observational study of the safEty of Maraviroc), located at the St. Luke’s and Roosevelt Hospital Center’s Center for Comprehensive Care (CCC), is an international, multi-center, observational study for HIV-1 positive persons who are currently taking or have experience taking HIV antiretroviral medications, and who are being considered for the drug maraviroc. At present the only means of slowing HIV disease progression is the use of highly active antiretroviral therapy (HAART). For patients who do not respond to preferred regimens, treatment may become complex due to difficulty with adherence, tolerability due to adverse events, drug interactions, and resistances. For these patients, new treatment regimens and new compounds are needed. The POEM study is measuring the safety of one of these new compounds, maraviroc. Maraviroc is a member of a new class of antiretroviral compounds known as CCR5 antagonists that cause a change in the CD4 lymphocyte immune cells that render them unrecognizable to the HIV-1 virus. Because there is limited information about the safety of long-term treatment with maraviroc in a large, diverse patient population, the study will enroll 1,500 HIV-1 infected, treatment-experienced adult patients who have been prescribed maraviroc, at 300 sites in multiple countries.

Contact: Phyllis Ristau (212) 523-6844

Study of the Safety of the 100mg and 200mg Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged >13 Years

Donna Mildvan, MD, Chief, Division of Infectious Diseases
Beth Israel Medical Center, AIDS Clinical Trials Unit, 350 East 17th Street, 3rd Floor, New York, NY 10003
Sponsor: Hoffman La Roche
Study ID: NV 25118

Duration: 30 days
Compensation to Participant: $20 per outpatient visit
Contact: (212) 420-4519 or 800-483-7339 or trials@bethisraelNY-HIVtrials.org

Title: A Randomized, Mulitcenter, Single Blinded, Parallel Study of the Safety of the 100mg and 200mg Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged ≥ 13 Years

Summary: This randomized, multi-center parallel-group study will evaluate the safety, pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in patients with influenza. Patients will be randomized to receive either 100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days, with an optional treatment extension, if necessary.

Phase #: 3

Eligibility Criteria:
Inclusion Criteria:

Patients, 18 years of age and older
Diagnosis of influenza
≤ 96 hours between the onset of influenza-like illness and first dose of study drug
Patient is willing and able to comply with study requirements and give informed consent
Female patients who are pregnant or lactating may be enrolled only if the potential benefit justifies potential risk to the fetus/infant

Exclusion Criteria:

Clinical evidence of severe hepatic decompensation at the time of randomization
Acute ischemia or significant arrhythmia on ECG
Creatinine clearance < 30 mL/min
Allergy to study drug
Use of probenicid
Participation in a clinical trial or expanded access trial with an investigational agent within 4 weeks

Drugs/Treatment Provided:

Arms	Assigned Interventions
Arm A	Oseltamivir 100 mg iv q12h for 5 days
Arm B	Oseltamivir 200 mg iv q12h for 5 days

The Safety of Maraviroc Used With Optimized Background Therapy in Treatment-Experienced HIV-1 Infected Patients (POEM)

Duration: Up to 5 years
Compensation to Participant: $25 for every on study clinic visit
Contact: (212) 420-4519 or 800-483-7339 or trials@bethisraelNY-HIVtrials.org

Title: An International, Multicenter, Prospective Observational Study of the Safety of Maraviroc Used With Optimized Background Therapy in Treatment-Experienced HIV-1 Infected Patients (POEM)

Summary: 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.

Phase #: 4
Study Design: Observational Cohort Prospective Study

Eligibility Criteria:
Inclusion Criteria:

Treatment experienced, HIV-1 infected patients
Age ≥ 18 years
Receive an approved assay for determination of HIV-1 tropism

Exclusion Criteria:
Pregnant or lactating

Using CCR5 inhibitor other than maraviroc

Drugs:

Groups/Cohorts	Observational Groups
Arm A - Maraviroc exposed	Maraviroc along with an optimized background antiretroviral drug regimen Maraviroc prescribed per approved local label.
Arm B - Maraviroc unexposed	Optimized background antiretroviral drug regimen without maraviroc Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.

Phase III Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572

Duration: 48 Weeks
Compensation to Participant: $50 per study visit
Contact: (212) 420-4519 or 800-483-7339 or trials@bethisraelNY-HIVtrials.org

Title: A Phase III Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered with an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral Therapy-Experienced Adults

Summary: ING111762 is a 48 week, randomized, double-blind, active-controlled 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 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.

Phase #: 3

Eligibility Criteria:
Inclusion Criteria:

Antiretroviral therapy (ART)-experienced
HIV-1 infection as documented by HIV-1 RNA >400 copies/mL
Have documented resistance (via Screening resistance test) to two or more different classes of antiretroviral agents
Integrase inhibitor (INI)-naïve, defined as no prior exposure to any INI (e.g. RAL, elvitegravir, or GSK1349572)

Exclusion Criteria:

Screening resistance test result indicates no fully active antiviral agents are available for design of the background regimen
Any evidence of an active AIDS-defining condition (except cutaneous Kaposi's sarcoma not requiring systemic therapy or CD4+ <200c/mm3)
Anticipated need for hepatitis C therapy during the study
History of malignancy within the past 5 years or ongoing malignancy

Drugs/Treatment Provided:

Arms	Assigned Interventions
Experimental: GSK1349572 + Raltegravir Placebo	Subjects will receive GSK1349572 50mg once daily plus raltegravir placebo twice daily + optimized background regimen
Active Comparator: Raltegravir + GSK1349572 Placebo	Subjects will receive raltegravir 400mg twice daily plus GSK1349572 placebo once daily + optimized background regimen

Online Cognitive Behavioral Therapy Intervention for the Treatment of Chronic Pain

Dr. Russell K. Portenoy
Beth Israel Medical Center - Dept. of Pain Management and Palliative Care

Web-Based Cognitive Behavioral Therapy for Opioid-Treated, Chronic Pain Patients with Aberrant Behavior: The National Development and Research Institutes in collaboration with the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center is conducting a study to develop, implement, and evaluate an innovative online cognitive behavioral therapy intervention for the treatment of chronic pain tailored to the specific needs of patients who are being prescribed opioids and present with aberrant behaviors.

Contact: Diana Vu (212) 844-6747

Sleep and Pregnancy Study

Dr. Marie-Pierre St. Onge
St. Luke’s & Roosevelt Hospitals
Obstetrics & Gynecology Department

Are you pregnant and interested in taking part in a research study? Want to know more about sleep during your pregnancy? During your visits to the Obstetrics and Gynecology department at Roosevelt Hospital you may be approached to take part in our research study. This research study will look at the effects of sleep on maternal health and infant outcomes. Participants will receive compensation for their time and contribution to scientific knowledge.

Contact: Majella O’Keeffe (212) 523-1616

Neropathological Abnormalities Define a Subgroup of Patients with Chronic Fatigue Syndrome

Dr. Benjamin Natelson, Attending, specializing in Chronic Fatigue Syndrome and Pain Medicine & Pallitive Care
Beth Israel Medical Center

More information available at www.painandfatigue.com

Chronic fatigue syndrome is a condition characterized by chronic and severe fatigue with no identifiable cause. Other symptoms often include tenderness in the muscles and joints, unrefreshing sleep, headaches, memory or concentration difficulties and the complaint that even minimal exertion makes individuals feel much worse. The purpose of this study is to develop a lab test to diagnose Chronic Fatigue Syndrome using cerebrospinal fluid (CSF). CSF is an important liquid that gives researchers a “window” into the brain because this fluid bathes the brain and protects it when bumped. To collect CSF, a procedure called a spinal tap is performed by the placement of a needle in the lower back, into a sac that is filled with CSF. Dr. Natelson and colleagues have used cutting-edge techniques to identify a number of substances that show CSF associated with Chronic Fatigue Syndrome differs from CSF associated with Lyme disease. The next step will be to identify the substances and then collect CSF from a new group of patients to determine which of these substances are found in the greatest number of patients (and not in healthy patients). These critical initial steps will help to develop a lab test to diagnose and ultimately better understand and treat Chronic Fatigue Syndrome. Eligible study participants are adults who experience long lasting and severe fatigue with no apparent cause or patients who have received the diagnosis of Chronic Fatigue Syndrome by a healthcare professional.

Contact: Diana Vu (212) 844-6747

The Effect of Milnacipran or Placebo on Ventricular Lactate and FM-Induced “Brain Fog”

Dr. Benjamin Natelson, Attending, specializing in Chronic Fatigue Syndrome and Pain Medicine & Pallitive Care
Beth Israel Medical Center

Fibromyalgia or FM is a clinical condition that lasts for many months and has no known cause. It is characterized by severe pain and tenderness when the muscles are pressed. Other symptoms may include fatigue, unrefreshing sleep, headaches, and memory or concentration difficulties. The primary objective of this double-blind, placebo-controlled study is to determine if patients with FM have an abnormal amount of a specific chemical within the brain that has been found to be the case in prior brain Magnetic Resonance Imaging (MRI) research studies. We will then use these data to determine whether minalcipran (Savella), and FDA-approved drug for FM, reduces this brain abnormality. The secondary objective of this study is to determine whether Milnacipran improves attention and concentration difficulties, which are frequent symptoms among FM patients. Eligible participants are adults who experience pain all over their body with no apparent cause, or patients who have received the diagnosis of Fibromyalgia by a healthcare professional.

Contact: Diana Vu (212) 844-6747

Hyponatremia

Dr. David Carr-Locke, Chief, Department of Digestive Diseases specializing in Gastroenterology
Beth Israel Medical Center

Hyponatremia is a common finding among hospitalized patients, and it is a well established predictor of high mortality in patients with cirrhosis, heart failure, and neurologic disorders. The purpose of this registry is to obtain demographic and clinical characteristics of patients who are being managed for hyponatremia. Patients hospitalized with hyponatremia will be eligible for this study. The inpatient clinical and laboratory data will be collected and entered into the registry. No medications will be given for this observational study.