• A5379: B-Enhancement of HBV vaccination in persons living with HIV (BEe-HIVe): Evaluation of HEPLISAV-B

    October 28, 2020 Alexis Sexton

    A5379 is a study looking at hepatitis B vaccination in adults living with HIV. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. The study will involve individuals who have received a previous hepatitis B vaccination but the vaccine did not respond well and individuals who have never received the vaccination. The study will take place both in the US and internationally. The study will compare how well an individual responds to the vaccine in different groups based on the type of vaccine and number of doses.

    Purpose of the Study: Vaccination for hepatitis B in individuals living with HIV does not always work, especially in those with impaired immune systems or ability to fight infection. Prevention of hepatitis B in individuals living with HIV has primarily been done by vaccinating with a series of 3 shots given over 6 months. A new vaccine, called HEPLISAV-B, has been approved that may provide a better response than what has currently been used. The researchers will study whether this vaccine will prove to be more effective than the current standard.

    Requirements to Enter Study:

    Living with HIV

    Been on HIV treatment for more than 56 days

    Previously received vaccines for hepatitis B, but the vaccines didn’t work

    There will be a small group of participants (73) who have never been vaccinated for hepatitis B.

    CD4 cell count (the number of white blood cells that fight infection) more than 100

    HIV viral load (how much HIV is in the body) less than 1000

    In the group vaccinated with a hepatitis B vaccine, the vaccination was over 168 days ago

    Exclusion: No previous hepatitis B infection or exposure to hepatitis B infection

    Treatment:  HEPLISAV-B vaccine given at entry and at 4 weeks or

    HEPLISAV-B vaccine given at entry, 4 weeks and 24 weeks or

    Engerix-B vaccine given at entry, 4 weeks and 24 weeks.

    Duration:  72 weeks

  • A5371: A Single-Arm, Open-Label, Pilot Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome with Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)

    October 8, 2020 Alexis Sexton

    Short Title: The Slim Liver Study

    Brief Description: About 30-40% of people living with HIV have a condition called NAFLD, or non-alcoholic fatty liver disease.  NAFLD is caused by high levels of stored fat in the liver. Most people with NAFLD also have other complications like high cholesterol, obesity, increased belly fat or type 2 diabetes. These complications can lead to cardiovascular disease (any disease of the heart or blood vessels that can lead to a stroke or heart attack).  In fact, most of the health problems that are associated with NAFLD are related to these conditions of the heart or metabolism.  Without treatment, NAFLD can advance to more serious liver disease. By using a drug that can lower the level of stored fat in the liver, people living with HIV may be able to treat NAFLD and reduce their risk of cardiovascular disease and other complications.

    Purpose of this Study: The purpose of this study is to evaluate the safety and tolerability of a drug called semaglutide and to see if it can reduce the amount of fat stored in the liver.

    Requirements to Enter Study (things that must be true for you):

    • Living with HIV with 2 HIV viral loads less than 50 copies in the last year and a CD4 T-cell count of at least 200
    • On your current HIV medications for at least 24 weeks
    • Willingness to have MRI scans
    • Agree to use contraception/birth control methods (if needed)
    • Able to store semaglutide in a cool location
    • Be 18 years old or older
    • Be willing to sign the consent after discussion with the research staff
    • Be willing to give yourself an injection once a week

    Exclusion Criteria (things that cannot be true for you):

    • Hepatitis B or C Virus infection (not previously treated)
    • Any plans to change diet or exercise significantly during the study period
    • Breastfeeding, pregnancy, or plans to become pregnant while on study
    • Liver disease with cirrhosis
    • Current diabetes mellitus
    • Chronic pancreatitis
    • Prior gastric (stomach) surgery (lab band, gastric sleeve or gastric bypass surgery) or plans to undergo one of these surgeries in the near future
    • High alcohol use

    Treatment:

    • Semaglutide subcutaneous injection once weekly for 24 weeks.

    Procedures:

    • Blood tests at clinic visits
    • Stool collections
    • MRI scans
    • Adherence monitoring, physical function assessment, food diary, and questionnaires

    Duration of Study: Approximately 48 weeks

  • A5380: Glecaprevir/pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)

    February 19, 2020 Alexis Sexton

    This is a study to treat participants, with or without HIV, who are found to have been recently infected with the Hepatitis C virus (HCV). This known as acute HCV.

    Purpose of this Study: People who are recently infected with HCV are often considered to have acute HCV. People with acute HCV have a good chance of being cured of the infection when they are treated with a combination of two drugs within the first 6 months of being infected. This study is being done to see if a shorter course of treatment will be effective if started early in the infection (Step 1). In case of failure with this shorter course of treatment, a longer and different treatment for HCV will be offered (Step 2).

    Requirements to Enter Study:

    • Age ≥18 years of age
    • With or without HIV. If living with HIV, on a stable treatment (antiretroviral regimen) or untreated due to lack of treatment per physician.
    • HIV RNA <50 and CD4 >100 cells/ mm3 (CD4 cells are a kind of white blood cell that are a measure of the immune system)
    • May not have Hepatitis B or prior Hepatitis C
    • Recently infected with HCV
    • Cannot be pregnant or breastfeeding
    • Must be willing to use birth control to prevent pregnancy
    • Must be willing to come to study visits
    • Must be able to swallow pills
    • May not have other known liver disease

    Study Drugs: Glecaprevir/pibrentasvir (G/P) Fixed-dose Combination (FDC-single tablet) three pills by mouth once a day for 4 weeks (Step 1). If this medicine does not work for you after the 4 weeks or you become infected again while on study, you will be asked to take the G/P with or without Ribavirin for a longer time, 8-16 weeks longer.

    Duration of Study: Up to 28 weeks on Step 1 and up to an additional 40 weeks if on Step 2.

  • A5360: MINMON Study-Monitoring SOF/VEL in Treatment Naïve, Chronic HCV Participants

    February 11, 2020 Alexis Sexton

    Full Title: “A Single-arm Study to Evaluate the Feasibility and Efficacy of a Minimal Monitoring Strategy to Deliver Pan-genotypic Ribavirin-free HCV Therapy to Chronically Infected HCV Treatment Naïve Populations Globally: The MINMON Study”

    Scientists are looking at ways to simplify Hepatitis C (HCV) treatment. This study will include people who are infected with HCV without decompensated cirrhosis (a condition where the liver is damaged and does not work well), regardless of HIV-1 co-infection (both with or without HIV infection will be accepted; either on ART [experienced] or not having started treatment [naïve]); and never have used treatment for Hepatitis C.

    Purpose of this Study: This study is trying to find out if minimal or less tests during treatment for Hepatitis C can be done safely  compared to the current standard monitoring tests (according to recent data and current practices for standard HCV monitoring). Participants will receive the fixed-dose combination (single tablet) of Sofosbuvir/Velpatasvir (SOF/VEL) for 12 weeks.

    Requirements to Enter Study (things that must be true for you):

    • Not having been previously treated for Hepatitis C infection with any medications.
    • Be willing to take drugs to treat HCV right away.
    • Have certain tests done that will be explained to you by the study coordinator
    • Agree to use contraception/birth control methods.
    • Be 18 years old or older.
    • Be willing to sign the consent after talking with the research staff.

    Exclusion Criteria (things that cannot be true about you):

    • Positive for the presence of Hepatitis B Virus.
    • Breastfeeding or pregnancy.
    • Known allergy/sensitivity or any hypersensitivity to components of study drug(s).
    • Active drug or alcohol use or dependence and other conditions that would interfere with adherence to study.
    • Acute or serious illness requiring systemic treatment and/or hospitalization within 35 days prior to study entry.
    • Any history of other hepatic illnesses other than HCV.

    Talk to your study staff for a complete list of inclusion/exclusion criteria.

    Treatment:

    • Fixed-dose combination of SOF/VEL single-tablet regimen for 12 weeks.

    Procedures:

    • Blood tests at clinic visits to check mainly liver and kidney function.
    • Telephone calls or text messaging for some study time points.
    • Adherence monitoring.

    Duration of Study: 72 weeks. 12 weeks on study treatment, followed by follow-up visits at weeks 24, 48 and 72.