studies

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

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

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.