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Open Clinical Trials

Clinical trials are studies designed to find new and better ways to treat patients. Through clinical trials, scientists and physicians at the Institute of Human Virology have broken new ground in the development of treatments. To enroll in a study call 410-706-1684.

The following clinical trials are currently open and accepting participants. Click a trial name below to learn more about the trial, including how to get involved. The eligible population is in parenthesis ( ) next to the trial name.

APOSTLE (Researching Hepatitis B Treatment)

Study:

APOSTLE (Researching Hepatitis B Treatment)

"A Phase II Open-Label Study of Ledipasvir/Sofosbuvir for 12 Weeks in Subjects with Hepatitis B Virus Infection"

Who It’s For:

Adults with hepatitis B for at least six months, that do not require treatment.

What it Does:

APOSTLE is a study to evaluate the use of a medication that is used for hepatitis C in people who have hepatitis B but do not require treatment.  Research labwork will help us learn if the hepatitis C study medication is having an effect on your hepatitis B. Participants will take the study medication once a day for 12 weeks, and have visits at weeks 1, 2, 4, 8, 12 and 3 times after the study treatment has completed.

Who Can Enter:

  • 18 or older
  • Not pregnant or planning pregnancy
  • Willing to use protocol specified birth control
  • Must have a primary care doctor/nurse
  • No advanced liver disease
  • Normal lab values
  • No significant heart or lung or neurologic diseases
  • No HIV, Hepatitis C or D
  • No cancers in last 5 years
  • No autoimmune disease or immunosuppression
  • No previous transplants
  • No other study drugs in last 90 day
  • No current substance abuse

Subjects will receive compensation for their time, parking and may receive transportation or mileage reimbursement.

Contact:

Amy Nelson at 410-706-0100 or John Woo at 410-706-6569

Clinical Trial Page on NIH Website:

Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection (APOSTLE)

Clinicaltrials.gov logo

GS-US-389-2024 | Hepatitis B

Study:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety, Tolerability and Antiviral Activity of GS-9688 in Virally-Suppressed Adult Subjects with Chronic Hepatitis B

Who It’s For:

Adults with hepatitis B that have been well controlled for at least six months on any of the following medications:

  • Tenofovir alafenamide
  • Tenofovir disoproxil fumurate
  • Entecavir
  • Adefovir
  • Lamivudine
  • Telbivudine

What it Does:

The goal for the study is to understand the safety and how well the investigational  study medication is tolerated when added to subjects usual hepatitis B treatment once a week for 24 weeks. Also, the study wants to know how if the Hepatitis B surface antigen level decreases in the blood after 24 weeks of treatment. Study Medication or Placebo (sugar pills) will be provided by the study.

Who Can Enter:

  • 18-65 year olds
  • Not pregnant or planning pregnancy
  • Willing to use protocol specified birth control
  • No change in hepatitis B treatment for at least 3 months
  • No advanced liver disease
  • Normal lab values
  • No significant heart or lung or neurologic diseases
  • No HIV, Hepatitis C or D
  • No cancers in last 5 years
  • No autoimmune disease or immunosuppression
  • No previous transplants
  • No other study drugs in last 90 day
  • No current substance abuse

Subjects will receive compensation for their time, parking and may receive transportation or mileage reimbursement.

Contact:

Amy Nelson at 410-706-0100

Clinical Trial Page on NIH Website:

GS-US-389-2024 | Hepatitis B

Clinicaltrials.gov logo

HIV CAT Study: Elucidating Chronic Hepatitis C Infection as a Risk Factor for Coronary Heart Disease in HIV-infected Patients

HIV CAT Study Flyer cover

Download HIV CAT Study Flyer

Study:

HIV CAT Study:Elucidating Chronic Hepatitis C Infection as a Risk Factor for Coronary Heart Disease in HIV-infected Patients is a observational research study evaluating the risk of heart disease among adults infected with HIV, chronic hepatitis C, and adults who are infected with both HIV and chronic hepatitis C.

What it Does:

The purpose of this study is to find out if chronic hepatitis C contributes to the development of heart disease in adult men and women and if it increases the risk and degree of heart disease in HIV + patients. Secondly, we are interested to study if those treated for Hepatitis C will reduce their risk of developing heart disease. Lastly, we are interested to study the levels of a blood test used to measure risk of developing heart disease and other blood tests that measure levels of inflammation and immune activation which may also be related to heart disease.

Who Can Enter:

To Be Eligible You Must Be: Adult infected with HIV, Hepatitis C, or both without prior heart disease or stroke(s) and not having chest pain or heaviness.

  • Age 18-70
  • Infected withHIV and/or Hepatitis C
  • Not taking statin or any other lipid lowering medication(s)
  • Not taking any diabetes medication(s)
  • HIV+ patients must have been on HIV regimen for 6 months or more and have undetectable HIV viral load
  • Hep C+ patients must be ready to start hepatitis medications through clinic provider or through hepatitis clinical trial
  • Had 2 clinic visits within past 12 months with clinical provider

For More Information Contact:

Alicia Jeffery, MA at 410-706-4069

The HOPE Study (Healthy Volunteers, Hepatitis C, Hepatitis B)

Download Flyer

Download Flyer

HOPE: An Omnibus Protocol to Characterize Patients with Hepatitis B and C is a research trial for adults who have or have had viral hepatitis B and/or hepatitis C and sometimes healthy volunteers (for comparison) and adults with chronic hepatitis B.

What it Does

  • Collects blood samples 1-2 times each year for up to 10 years to study the viruses and the immune system.
  • Provides Tenofovir Alafenamide (TAF) for two years with visits every three months to collect blood samples.

What it's For

  • Provides Tenofovir Alafenamide (TAF) for two years with visits every three months to collect blood samples.
  • Adults 18 and over
  • With hepatitis B or C, or who have cleared hepatitis B or C, or healthy volunteers

To Be Eligible You Must:

  • Be 18 years old and over
  • Have hepatitis B or C, or who have cleared hepatitis B or C, or be a healthy volunteer
  • Have blood samples stored for future research
  • Must have a primary care provider
  • Be willing to have HIV testing
  • Have veins that allow specimen collection
  • May not be pregnant or breastfeeding

For More Information

  • For information about the annual visit blood draw study, contact: Haley Ward, 410-706-6569
  • For information about the sub-study with standard-of-care treatment for chronic hepatitis B contact: Ka Wing (Joyce) Lam, 410-706-3367
  • Or go to www.clinicaltrials.gov

MAVERIC (Hepatitis C)

Download Flyer

MAVERIC is a research study to test whether the HIV medication called maraviroc affects the hepatitis C virus. All study visits will be conducted at the Institute of Human Virology at the University of Maryland. All study medicine and testing are provided free to participants. Compensation for travel and time is provided.

To Be Eligible You Must Be:

  • 18 years or older
  • Have untreated hepatitis C
  • Have HIV and are on treatment

For More Information Contact:

Dr Lydia Tang at 410-706-6567 or go to www.clinicaltrials.gov.

MISP (Hepatitis C and Pre and Post Kidney Transplant)

MISP is a study evaluating the use of FDA approved medication Zepatier (Grazoprevir and Elbasvir) to see if there is difference in the immune system response to treatment either before or after kidney transplant. Medication will be provided free of cost and research blood samples will be collected.

To Be Eligible You Must:

  • Be 18 years or older
  • Have hepatitis C (genotype 1) infection
  • Not have liver cirrhosis
  • Have either chronic kidney disease or have had a kidney transplant

For More Information Contact:

RT5 (Hepatitis C and Post Kidney Transplant)

RT5 is a study to evaluate the use of FDA approved medications (Maraviroc and Sirolimus) in HIV+ kidney transplant recipients to determine if it will reduce HIV DNA. Medications will be paid for through the volunteers insurance, research blood samples will be collected.

To Be Eligible You Must:

  • Be HIV+
  • Be at least 6 months post-kidney transplant with stable kidney function
  • On antiretroviral therapy for at least 6 months
  • Have a CD4 count >200

For More Information Contact:

Ilise Marrazzo, RN, MPH at 410-706-2564 or visit www.clinicaltrials.gov.


IHV Clinical Trials Unit

Institute of Human Virology
725 W. Lombard Street
Baltimore, MD 21201

Directions to IHV Patient Parking

To enroll in a study call 410-706-1684.