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Clinical Research Unit

Division of Infectious Diseases - Clinical Research Unit

The Clinical Research Unit (CRU) is a critical research partner to the Partnership Comprehensive Care Practice of Drexel University College of Medicine, established more than 25 years ago to integrate all aspects of medical, social, and behavioral care in one clinical center for people living with HIV in the Philadelphia area.

About the Clinical Research Unit

At its inception, the Partnership Comprehensive Care Practice was created as a nontraditional model in the region for treating HIV/AIDS patients, which focused comprehensively on the well-being of the entire individual. The Partnership has grown to be a highly respected, national leader for providing exceptional care to patients from a neighborhood populated primarily by people from underrepresented minorities and other members of health care-underserved communities.

A powerful, NIH-funded research and training program in basic, translational and clinical science complements the clinical practice at the Clinical Research Unit. Overall, the College of Medicine’s effort in HIV/AIDS is a superior example of how an academic health center brings clinicians and scientists together to meet the health needs of patients while creating the next generation of vaccines, therapeutics and a cure for this devastating disease.

Clinical research is an integral part of health care and one of the best ways to get new and improved treatments or access to new medications. The clinical trials and research opportunities available at the Partnership evaluate experimental drugs, treatment options and other aspects of health for patients at all stages of HIV disease. The Clinical Research Unit medical team and staff guide interested patients through all stages of the research process and provides expert health care coordination to all research participants.

The Clinical Research Unit is a locked space of approximately 4,500 square feet supporting clinical research studies and patient navigation, with a comfortable waiting room, a phlebotomy room, exam rooms, a pharmacy, an infusion suite and study staff offices and conference space. In addition, the Clinical Research Unit houses a state-of-the-art BSL2 laboratory that supports patient specimen processing and long-term storage of clinical samples for research.

Clinical Research Unit Staff

Carolyn Edwards, RN, MSN (Clinical Research Unit)

Carolyn Edwards, RN, MSN

Clinical Research Nurse
Tel: 267.507.6768
Email: cye22@drexel.edu

Theresa Linus RN, BSN (Clinical Research Unit)

Theresa Linus RN, BSN

Clinical Research Nurse
Tel: 267.507.6819
Email: tcl52drexel.edu

Kim Malone, BS NRCMA NRCPT (Clinical Research Unit)

Kim Malone, BS NRCMA NRCPT

Research Associate II
Tel: 267.507.6645
Email: km324@drexel.edu

Shinika Tillman (Clinical Research Unit)

Shinika Tillman

Research Associate I
Tel: 267.507.6609
Email: st486@drexel.edu

Diana Surita (Clinical Research Unit)

Diana Surita

Research Associate I
Tel: 215.762.7618
da643@drexel.edu

Rick Adams (Clinical Research Unit)

Rick Adams

Research Grants & Business Administrator
Tel: 215.762.7614
ra936@drexel.edu

Clinical Trials Open to Enrollment

How Do People Treat You - Online Survey
We want to hear from you about being treated differently because of who you are and how it affects your health.

Description: If you are interested in participated, please visit https://drexel.qualtrics.com/jfe/form/SV_3QPy1osLBz74GF0?Source=directorg (online survey and compensation/encuesta en linea y compensacion)

Contact: treatyou@drexel.edu

Download Flyer / Descargar Folleto

Impact of Medical Marijuana on Quality of Life Outcomes in People Living with HIV with Neuropathic Pain and/or PTSD
PI: Wei Du, MD
Sponsor: Medical Marijuana Research Center, Drexel University
Description: We are enrolling participants in a study to learn how medical marijuana affects the health of people living with human immunodeficiency virus (HIV). 1) We are particularly interested in individuals with HIV-related nerve pain or 2) post-traumatic stress disorder (PTSD), but are also recruiting individuals without nerve pain or PTSD for comparison purposes.

Eligibility Criteria:

  • You have HIV
  • You are 18 years or older and have a valid PA Medical Marijuana Card
  • You plan to begin taking medical marijuana for your medical conditions (HIV, PTSD, HIV-related nerve pain) but have not yet started
  • You can afford medical marijuana and are willing to use Verano products

Contact: MedicalCannabisStudy@drexel.edu or call 215.762.7770.

Extended Use of Tecovirimat at PCCP (Non-research)
PI: Amy Althoff, MD
Sponsor: NA
Description: This is a non-research expanded access Investigational New Drug protocol that allows for the use of Tecovirimat for monkeypox infections. The link to the protocol is: https://www.cdc.gov/poxvirus/monkeypox/clinicians/Tecovirimat.html#print
Eligibility Criteria: Be a PCCP patient over the age of 18 showing signs of monkeypox infection
Contact: Carolyn Edwards (267.507.6768)

Clinical and Translational Research Support Core of the Comprehensive NeuroHIV Center
PI: Brian Wigdahl, PhD
Sponsor: NIH
Description: We invite you (English or Spanish speaking) to take part in a research study because you are an HIV-1 infected patient over the age of 18, or you are an uninfected patient who will be a part of our control group.
Lo invitamos a participar en un estudio de investigación porque es un paciente infectado por el VIH-1 y es mayor de 18 años o es un paciente no infectado que formará parte de nuestro grupo de control.
Eligibility Criteria: Subjects 18 years of age and older that are HIV positive
Contact: Kim Malone - 267.507.6645 or Shinika Tillman - 267.507.6609

Clinical Trials Closed to Enrollment

Contact: Carolyn Edwards (267.507.6768)

Long-term Follow-up of Subjects Exposed to Retroviral based Gene Therapy Products in HIV Studies
PI: Elliot Goodenough, MD
Sponsor: Takara Bio Inc.
Eligibility Status: Closed to enrollment
You are being asked to participate in this study because the previous study you were enrolled into, was a study that involved receiving your own cells that were changed, using a retroviral vector. A retroviral vector is a virus that can insert genetic material into cells. When retroviral vectors enter a normal cell in the body, the deoxyribonucleic acid (DNA) of the vector inserts itself into the normal DNA in that cell. This process is called DNA integration.

Description: The purpose of this research study is to monitor your health status in accordance with the Food and Drug Administration guidelines. These guidelines require the research team to follow your health status for up to 15 years when subjects have participated in research studies that have received cells that have been permanently modified by a gene therapy product (called gene transfer).

REPRIEVE: Randomized Trial to Prevent Vascular Events in HIV
PI: Elliot Goodenough, MD
Sponsor: NIH
Enrollment Status: Closed to enrollment
Description: This study aims to determine the effects of pitavastatin as a primary prevention strategy for major adverse cardiovascular events (MACE) in HIV positive individuals. View publications.

MazF: Long-term Follow-up of Subjects Exposed to Retroviral-based MazF-modified T-cell Gene Therapy Products (MazF-T) in HIV Studies
PI: Amy Althoff, MD
Sponsor: Takara Bio, Inc.
Enrollment Status: Closed to enrollment
Description: This is an ongoing destination protocol for all adult subjects who have received a gene therapy product that had been permanently modified by retroviral vector (MazF-T). Participants entering this protocol will be followed for up to 15 years after the initial MazF-modified T cell infusion.

IMPACC: A Prospective Cohort Study to Assess Longitudinal Immune Responses in Hospitalized Patients with COVID-19
PI: Charles Cairns, MD
Sponsor: NIH
Enrollment Status: Closed to enrollment
Description: This study is an observational cohort that will collect detailed clinical, laboratory, and radiographic data in coordination with biologic sampling of blood and respiratory secretions and viral shedding in nasal secretions in order to identify immunophenotypic and genomic features of COVID-19 -related susceptibility and/or progression in order to generate hypotheses for effective host-directed therapeutic interventions, to help to prioritize proposals for such interventions, and/or optimize timing for administration of host-response directed therapeutics.

DTG: A multi-site observational study to assess safety and effectiveness of prenatal exposure to Dolutegravir in HIV positive pregnant women
PI: Amy Baranoski, MD
Sponsor: GSK
Enrollment Status: Closed to enrollment
Description: This multi-site observational study aims to assess the safety and effectiveness of DTG use among potentially up to 2000 HIV positive pregnant women. Data will be collected through retrospective review and abstraction of patient medical records that capture, as appropriate, the standard of care (SoC) and treatment decisions made by the healthcare providers (HCPs). There are no study related interventions or study procedures related to patient care.

CLOVER: A Phase 3, Placebo-controlled, randomized, observer-blinded study to evaluate the efficacy, safety, and tolerability of a C. difficile vaccine in adults 50 years and older
PI: Amy Althoff, MD
Sponsor: Pfizer
Enrollment Status: Closed to enrollment
Description: This is a phase 3, placebo-controlled, randomized, observer-blinded study to evaluate the efficacy, safety, and tolerability of aluminum hydroxide (AlOH)-containing C difficile vaccine (200 μg total toxoid) administered as a 3-dose regimen at Months 0, 1, and 6 inadults 50 years of age and older. Subjects will be randomly assigned in parallel in a 1:1 ratio to receive C difficile vaccine (200 μg total toxoid) or placebo (saline).

Pfizer/CDIFF: Identification of risk factors to Clostridium difficile infection At Hahnemann University Hospital
PI: Michele Kutzler, PhD
Sponsor: Pfizer
Enrollment Status: Closed to enrollment
Description: The objective of this study is to carry out a case-control prospective clinical study at HUH to identify through questionnaire and medical chart review patient-specific risk factors for acquisition of CD and disease recurrence. Hypothesis: That patients at high risk for acquiring severe and recurrent CDI will correlate with host factors that include increased frequency of lower socioeconomic status, African American racial backgrounds, lower educational levels, higher BMI, presence of chronic diseases associated with immunodeficiency or other conditions (HIV-1, IBD, diabetes, renal disease, metastatic cancers, chronic pulmonary disease) and documented illicit drug use.

Clinical Research Unit Location

Division of Infectious Disease & HIV Medicine Clinical Research Unit
1427 Vine Street, 3rd floor
Philadelphia, PA 19102
Tel: 267.507.6647 (Research Department)
Fax: 267.507.6927


The information on these pages is provided for general information only and should not be used for diagnosis or treatment, or as a substitute for consultation with a physician or health care professional. If you have specific questions or concerns about your health, you should consult your health care professional.

The images being used are for illustrative purposes only; any person depicted is a model.

 
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