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.
Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay
Clinical Trial Page on NIH Website:
To enroll in this study call 410-706-1684
CALIBER - CD24F Administration to Decrease LDL and Inflammation in HIV Patients
CHROME
Clinical Trial Page on NIH Website:
CHROME - Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication
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:
HIV CAT Study: Elucidating Chronic Hepatitis C Infection as a Risk Factor for Coronary Heart Disease in HIV-infected Patients
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:
Lora Conn 410-706-1720
The HOPE Study (Healthy Volunteers, Hepatitis C, Hepatitis B)
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 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
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.