• ACTG A5362: A Phase IIc Trial of Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study

    June 17, 2021 Alexis Sexton

    Study Description
    A5362 is a study for people with pulmonary tuberculosis (TB) without evidence of resistance to the TB drugs isoniazid (INH) or rifampin (RIF). Participants will be enrolled in one of three treatment groups. Duration of treatment will vary depending on which treatment group the participant is enrolled, but all participants will be in the study for 65 weeks.

    Study Status:    Open to Accrual

    Why is this study being done?

    • To determine if taking a shorter 3-month regimen of a new combination of TB drugs is better than taking a 6-month regimen that is standard of care for the treatment of TB.
    • To look at the tolerability of the study drugs, the effect the drugs have on the electrical activity of the heart, and will measure the level of these drugs in blood.

    Who can join?

    People who:

    • Are 18 years of age or older
    • Have pulmonary TB with or without history of prior treatment, and without known resistance of INH or RIF
    • Have a normal chest X-ray at screening
    • For participants living with HIV: CD4 cell count ≥100 and taking or planning to take anti-HIV therapy
    • Not more than 5 days of treatment directed against active TB for the current TB episode

    What do I need to do in the study?

    For this three-arm study, participants will receive treatment in either:

    Arm 1

    Rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) high dose for 2 weeks; then PHZE + CFZ standard dose for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ standard dose 5 weeks, for a total of 13 weeks of study treatment.

    Arm 2 (Standard of Care)

    Rifampin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampin/isoniazid (RH) for 18 weeks, for a total of 26 weeks of study treatment.

    Arm C

    PHZE + CFZ standard dose for 4 weeks; switch to standard of care, completing RHZE for 4 weeks; then RH for 18 weeks.

    All participants will have blood samples taken to measure the amount of anti-TB drugs in the body, and pictures taken to look for changes in skin color. All participants will undergo routine safety monitoring.  Participants will be followed in the study for 65 weeks.

    What treatments or drugs are involved with this study?

    Study TB medications are provided by the study. Antiretroviral medications are not provided by the study.

  • A5386: N-803 with or without bNAbs for HIV-1 control in participants living with HIV-1 on suppressive ART

    May 26, 2021 Alexis Sexton

    Full Title: A Phase 1 Clinical Trial of the Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) with and without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption

    Scientists are looking for ways to effectively clear HIV that rests in areas of the body where standard antiretroviral treatment (ART) is unable to reach. IL-15 superagonist (N-803) appears to reactivate HIV that is “asleep” and is also thought to increase the body’s natural immune response to HIV. Broadly neutralizing antibodies (bNAbs), such as 10-1074 and VRC07-523LS, have been shown to control growth of HIV in the blood and to increase the body’s immune response to HIV. N-803 alone or in combination with bNAbs may provide greater control of HIV than previous efforts.

    Purpose of this Study: This research study is trying to find out if N-803, VRC07-523LS, and 10-1074 are safe and effective at reactivating and targeting the latent cell pool of HIV RNA during an ATI (analytical treatment interruption). All participants will receive eight doses of N-803. Half of participants will also receive 10-1074 and VRC07-523LS. A year after starting study treatment, participants will stop ART for up to 24 weeks to see how well their immune systems control growth of HIV (analytic treatment interruption or ATI).  Participants will be followed closely to see if ART should be restarted. After restarting ART, participants will be followed for another 24 weeks.

    Major requirements for entering the study (things that must be true for you):

    • Living with HIV.
    • Have a low or undetectable viral load for at least 2 years.
    • Be willing to take a superagonist and broadly neutralizing antibodies and complete study related tests.
    • Agree to use contraception/birth control methods.
    • Be between 18 and 70 years old.
    • Be willing to temporarily stop taking antiretrovirals or ART.

    Events or conditions that would prevent you from participating (things that cannot be true about you):

    • Recent serious illness or condition requiring hospitalization.
    • Breastfeeding or pregnant.
    • Active Hepatitis B or C infection or history of AIDS-defining conditions.
    • Current CD4 cell count less than 500 or ever had a CD4 cell count less than 200.

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


    • Eight doses of N-803 given by needle under the skin; half of participants will receive two doses of 10-1074 and one dose of VRC07-523LS given intravenously (through a catheter in the vein).


    • Blood and urine tests at scheduled clinic visits for safety evaluations and to check your immune function.
    • Leukapheresis (collection of immune cells through a catheter in the vein) (a procedure similar to donating platelets) will be completed twice.
    • Lymph node fine-needle aspirate (a type of biopsy using a needle) is an optional procedure which will be done prior to study entry and at Week 13.

    Duration of Study: Maximum of 2 years. Arm A will receive one dose of N-803 at Week 1 and then every 3 weeks for a total of eight doses. Arm B will receive one dose each of VRC07-523LS and 10-1074 at Step 1 entry, a dose of N-803 at Week 1 and then every 3 weeks for a total of eight doses, and a second dose of 10-1074 at Week 9. Follow-up visits will occur at Weeks 26, 32, 46 and 52. Week 52 also marks the beginning of the ATI, which can last up to 24 weeks of frequent visits. There will also be follow-up visits at 4, 12, and 24 weeks from the restart of ART.

  • A5391: Doravirine for Persons with Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study)

    May 20, 2021 Alexis Sexton

    Weight gain after starting antiretroviral therapy (ART) is common, but recent studies have found that some people living with HIV (PLWH) who are taking an integrase strand transfer inhibitor (INSTI) combined with tenofovir alafenamide/emtricitabine (TAF/FTC) or tenofovir alafenamide/lamivudine (TAF/3TC) may gain more weight than people taking other drug combinations. A rising number PLWH are overweight or obese. Higher BMI and weight gain on ART increase the risk for diabetes, heart disease and stroke. Researchers are looking to see if PLWH who have gained a significant amount of weight after starting or switching to an INSTI-containing regimen, can either reduce their rate of weight gain over time or even lose weight with a change to a different ART regimen. This study will include participants who are living with HIV-1, who have been virally suppressed for > 48 weeks on a regimen consisting of an INSTI and TAF/FTC or TAF/3TC and who have experienced > 10% weight gain since the initiation of this ART regimen.

    Purpose of this Study: This research study is trying to find out if PLWH who had > 10% weight gain after starting an antiretroviral therapy (ART) regimen that included an INSTI in combination with TAF/FTC (or TAF/3TC) could gain less weight, or maybe lose weight, after switching to an ART regimen containing doravirine (DOR) with either TAF/FTC (or TAF/3TC), or the related medication tenofovir disoproxil fumarate/emtricitabine (TDF/FTC [or TDF/3TC]). DOR is an FDA-approved antiretroviral drug for the treatment of HIV-1 and a member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) medication class. In multiple studies, DOR was shown to be just as effective as INSTI medications for treating HIV.

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

    • Living with HIV-1.
    • Be ≥ 18 years old.
    • Currently on an Integrase Inhibitor (INSTI) containing regimen (BIC, DTG or RAL), with > 48 weeks INSTI+TAF/FTC (or TAF/3TC) dosing prior to study entry.
    • Have experienced > 10% weight gain in the 1-3 years after starting these medications.
    • Have a body mass index (BMI) >5 kg/m2.
    • Have study related tests done, including a DEXA Scan (X-Ray Scan measuring measure lean muscle, body fat and bone density).
    • Agree to use contraception/birth control methods if capable of becoming pregnant.
    • Be willing to change ART if randomized to Arms 1 or 2.

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

    • Recent serious illness or condition requiring hospitalization.
    • Breastfeeding or pregnant.
    • Historic or current evidence of resistance to the study medication or other medications in its class.
    • Plans to undergo weight loss surgery or to start significant changes to your diet or exercise habits

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


    When you enter this study, you will be randomized (assigned by chance, as if by roll of dice) to one of three study groups. Because the randomization is equal, you will have a 33% chance of being in any of the following study groups:

    1. Group 1: You will continue taking TAF/FTC (or TAF/3TC) but will stop your INSTI and take DOR; your ART will be DOR+TAF/FTC (or TAF/3TC) for 48 weeks.
    2. Group 2: You will stop your INSTI and TAF/FTC (or TAF/3TC) and will switch to DOR+TDF/FTC (or TDF/3TC) for 48 weeks.
    3. Group 3: You will continue your current ART of an INSTI+TAF/FTC (or TAF/3TC) for 48 weeks.


    • Blood and urine tests at scheduled clinic visits for safety evaluations and other research testing.
    • Questionnaires asking for information on adherence to ART and diet and exercise habits.
    • DEXA Scan (Dual-Energy X-Ray Absorptiometry) to measure lean muscle, body fat and bone density.

    Duration of Study: Almost 1 year (48 weeks). Follow-up visits will occur at Weeks 4, 12, 24, 36 and 48 (study completion).

  • A5343: A Trial of the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, among Participants Taking Multidrug Treatment for Drug-Resistant Pulmonary Tuberculosis

    February 20, 2020 Alexis Sexton

    This is a randomized study, which means, by chance, you will be in one of three groups. You have an equal chance of being assigned to a group like flipping a coin. A5343 is an open label clinical trial, which means you will know which group you are in and what medications you will be taking.

    This study will compare three treatment arms for people who have pulmonary multidrug resistant tuberculosis (MDR-TB). Pulmonary MDR-TB is a form of tuberculosis (TB) in the lung that is resistant to two or more of the primary drugs used for the treatment of TB (isoniazid and rifampin).

    You will receive standard treatment for MDR-TB plus one or two new drugs for TB, called bedaquiline (BDQ) and delamanid (DLM). Throughout the study, you will be monitored to make sure that there are no safety concerns. Your heart will be monitored closely to make sure it is safe to give the drugs together.

    Purposes of the Study:

    This study looks at how the two new drugs fight MDR-TB when used alone with other TB drugs or used together. It looks at how the TB drugs work inside the body when you take them. It also looks at how safe and well tolerated these two drugs are in people.. Multiple times throughout the study, blood samples and an ECG, a test that measures the electrical activity in your heart, will be done to monitor the safety of the drugs.

    Requirements to Enter Study:

    Inclusion Criteria: To be in the study, you must:

    • Be age 18 or older
    • Have MDR-TB in your lungs and be on treatment less than 8 weeks
    • Not be pregnant or breastfeeding
    • Use an approved form of birth control for both men and women
    • For persons with HIV : CD4 count above 100 cells/mm3 (CD4 cells are a kind of white blood cell that are a measure of the immune system)
    • Taking treatment for MDR-TB before joining the study
    • Willing to stay in hospital for at least 2 months
    • Able to take pills by mouth
    • Consent in writing to be in the study

    Exclusion Criteria: You cannot be in the study if you:

    • Have MDR-TB that does not involve the lungs
    • Have received BDQ or DLM in the past
    • Have any allergies to the study drugs
    • Are actively drinking alcohol or using drugs
    • Have heart problems or other serious illness
    • Require or may require the use of certain drugs to treat HIV at the same time you are taking study drugs
    • Require or may require the use of certain drugs, including, but not limited to, clofazimine and moxifloxacin, from 48 hours prior to study entry through 4 weeks after stopping study drugs

    Study Treatment:

    The treatment arms are:

    • Arm 1: BDQ (comes as a tablet to take by mouth)
    • Arm 2: DLM (comes as a tablet to take by mouth)
    • Arm 3: Both BDQ and DLM (as above)

    The duration and doses will be explained by the study nurse or study doctor.

    Length of Study:

    24 weeks on study treatment, followed by 104 weeks follow-up, for a total length of 128 weeks

    Number of Participants:

    Up to 84 people will enroll in this study

  • A5300B/I2003B:Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Participants (PHOENIx)

    February 20, 2020 Alexis Sexton

    This trial is in household contacts (HHC) at high risk for developing multidrug resistant tuberculosis (MDR-TB) which is an infection that does not get better with standard treatment for TB.  HHC means any person that  lives with, has lived with, or shared housekeeping duties in a home or the same place with a person (an Index Case) who has pulmonary MDR-TB (a lung infection or pneumonia with TB) and started treatment for MDR-TB within the past 90 days. It is also for people who have spent more than 4 hours indoors with the index case, during the week before they started MDR-TB treatment.

    High-risk household contacts are those with HIV or an immune system problem not from HIV like cancer , latent TB infection (a history of TB infection in the past based on testing), and young children below the age of 5 years.

    Purpose of this Study: 

    Is to compare how safe and effective 26 weeks of Delamanid (DLM), a medicine used to treat TB,  is versus 26 weeks of isoniazid (INH), a standard medicine to treat or prevent TB,  for preventing infection with TB (latent TB) or confirmed or probable active infection with TB among participantshigh risk HHC (see above for description).

    Requirements to Enter Study:

    The Index Case must be an adult (18 years and older) with pulmonary MDR-TB who has started MDR-TB treatment within the past 90 days, who has one or more household contacts and gives site staff permission to call and visit the household contacts.

    The Household contact must be a High-Risk Contact:

    • Children up to 5 years of age regardless of standard tests for TB known as the tuberculin skin test (TST) or the interferon gamma release assay (IGRA), a blood test for TB, or HIV status.
    • Adults, adolescents, and children ≥5 years of age who are TST-positive (defined as a skin test bump ≥5 mm in size) and/or IGRA test-positive and whose HIV status is negative, indeterminate, or unknown and who are not immunosuppressed from another condition besides HIV.
    • Adults, adolescents, and children ≥5 years of age who are HIV-infected or are immunosuppressed without HIV (defined as receiving anti-tumor necrosis factor (TNF) treatment, or in chronic renal failure receiving dialysis, or being solid organ or hematologic transplant recipients), regardless of TST/IGRA


    Household contacts will be randomly assigned (like a flip of a coin) one of two groups:

    Group A will receive:

    DLM daily for adults, adolescents, and children, given for 26 weeks

    Group B will receive:

    • INH daily for adults, adolescents, and children, given for 26 weeks
    • Pyridoxine (vitamin B6) daily for adults, adolescents, and children, given for 26 weeks

    All high-risk HHCs in the same HH will receive the same randomized regimen.

    Duration of Study:

    All participants will be in this study for 96 weeks.

    Document list:


    A5300B/I2003B V3 Final Protocol dated March 31, 2020

    A5300B/I2003B V3 Manual of Procedures dated May 6, 2022

    A5300B/I2003B V3 Lab Processing Chart dated May 3, 2022

  • A5381: Observational Cohort to Assess Therapeutic Efficacy and Emergence of HIV Drug Resistance Following Initiation of Tenofovir-Lamivudine-Dolutegravir (TLD) for First- or Second-Line ART

    February 11, 2020 Alexis Sexton

    This is a study for people who have HIV and qualify to switch to or receive Dolutegravir containing antiretroviral therapy (ART, group of medicine used to treat HIV). Taking TLD (combination pill of three medicines for HIV, tenofovir-lamivudine-dolutegravir) has shown to be better tolerated, work better against the virus known as virologic efficacy, have fewer drug-drug interactions, and have less frequent onset of HIV drug resistance than Efavirenz containing ART. In August 2017, a decision was made to start using TLD for first- and second-line ART in many places in the world. This study is designed to help us understand the risks and benefits of TLD roll-out in low- and middle-income countries that may not use viral load testing and HIV resistance testing (a way to measure if a drug will work against your HIV) to guide ART management.  Each participant will be assigned to one of four groups:

    • Group 1: Participants switching to TLD, after taking prior anti-HIV medication that contains a NNRTI drug (a group of medicines scientifically known as non-nucleoside reverse transcriptase inhibitors, such as Efavirenz or Nevirapine).
    • Group 2: Participants switching to TLD, after taking anti-HIV medication that contains a PI drug (a group of medicines scientifically known as protease inhibitors, such as Lopinavir or Atazanavir).
    • Group 3: Participants taking TLD and receiving medication for TB (tuberculosis) that includes the drug rifampicin. These participants must be starting one or both of these medications when they enter the study.
    • Group 4: Participants starting TLD who have not taken anti-HIV medication before.

    There will be 1350 participants enrolled in the study.

    Purpose of the study

    To better understand risks and benefits of Tenofovir-Lamivudine-Dolutegravir (TLD) roll out in programs done in low- and middle-income countries.

    Requirements to enter the study

    Persons with HIV  age 10 years or older

    Body weight at least 30 kg

    Starting or switching to Tenofovir-Lamivudine-Dolutegravir (TLD)

    Currently receiving or planning to receive care in a program supported by the United States President’s Emergency Plan for AIDs Relief (PEPFAR).

    Study Treatment

    There will be no treatment provided through the study.


    Each participant will be followed for 36 months.

  • A5361s: Pitavastatin to REduce Physical Function Impairment and FRailty in HIV (PREPARE)

    February 11, 2020 Alexis Sexton

    Aging with HIV may be associated with an earlier development of frailty (weakness) or disability, including difficulties in tests of strength or walking speed. Few treatments have been shown to prevent or slow these impairments in people with or without HIV. Some studies have suggested that the class of drugs called statins, such as pitavastatin, might be helpful in slowing frailty or disability. This might happen by decreasing fat within the muscle, or by decreasing inflammation markers in the blood. This study uses the REPRIEVE Trial (A5332) and the REPRIEVE Mechanistic Substudy (A5333s) to study the impact of pitavastatin on muscle.

    Requirements to enter the Study:

    • You must already be enrolled in REPRIEVE trial (A5332) and the REPRIEVE Mechanistic Substudy (A5333s)
    • Taking pitavastatin or placebo as part of REPRIEVE (A5332)
    • Willing to complete study procedures

    Study Procedures

    As part of A5361s, muscle strength and muscle function will be measured at yearly visits. Tests will include repeated chair rises, hand grip strength test, standing balance test and a 12 foot (4 meter) timed walk. Participants will also be asked questions about their physical activity.

    CT scans (done already in A5333s) will be looked at carefully for muscle size and fat amount and blood samples (collected in A5332) will be analyzed for changes in biomarkers. No additional CT scans or blood will be collected on A5361s.

    Duration of Study:

    Participants will be followed for 48 months from the date of enrollment into A5332. Based on their date of enrollment into A5332, participants may be followed between 24 to 48 months.

  • A5332: REPRIEVE Trial

    February 11, 2020 Alexis Sexton

    In this study, people between the ages of 40 and 75 with HIV will be randomized (like flipping a coin) to take the pill pitavastatin OR a placebo (non-active pill) to see if pitavastatin can help prevent heart disease and death in people who are taking HIV medication. You will not know if you are taking pitavastatin or placebo. The REPRIEVE trial will enroll about 7500 people from several countries.

    Purpose of this Study:

    HIV causes inflammation (irritation) inside the body that cannot be felt but can be measured. Inflammation may contribute to diseases such as heart disease that have become some of the leading causes of death in people with HIV. HIV medications can lower inflammation somewhat, however sometimes the levels of inflammation can remain higher compared to people who do not have HIV.

    Statins (name of the group of medicines that pitavastatin belongs to) are used to lower the levels of cholesterol and triglycerides (fat in the blood) that people make. Studies have shown that statins may have other benefits. For example, heart disease and the levels of inflammation can be lowered by statins.

    Pitavastatin is a statin that, along with a diet, has been approved by the US Food and Drug Administration for the treatment of high cholesterol. It also lowers triglyceride levels in the blood.

    The main purpose of this clinical trial is to see if pitavastatin can prevent heart disease and heart disease related deaths in people with HIV who are taking HIV medications.

    Requirements to Enter Study: The study coordinator will review all of the criteria necessary to be eligible for the study with you. Listed below are a few key points.

    • Persons with HIV who are between the ages of 40 and 75.
    • On antiretroviral therapy (ART, medicine to treat HIV) for at least 6 months prior to study entry.
    • CD4+ cell count >100. (CD4 cells are a kind of white blood cell that are a measure of the immune system)
    • Must not be pregnant or planning to become pregnant.
    • No history of cardiovascular disease (history of heart attack or stroke, etc.).
    • No history of cancer in the last year.
    • Not currently using a statin drug.

    Treatment: Participants will be randomized (like flipping a coin) to take either:

    • Pitavastatin 4 mg one pill daily with or without food or
    • Placebo for pitavastatin one pill daily with or without food

    Duration of Study: You will be in this study for about 36 to 96 months depending on when you enroll in the study. You will need to be seen in clinic for a screening visit, an entry visit, one month later, and then every 4 months.

  • A5322: Long-Term Follow-up of Older HIV-infected Adults in the ACTG: Addressing Issues of Aging, HIV Infection and Inflammation (HAILO)

    February 11, 2020 Alexis Sexton

    You are being asked to take part in this research study because you are infected with HIV, the virus that causes AIDS, and were previously followed in the ALLRT (A5001) study and are 40 years of age or older. This study, A5322 (also known as the HAILO study), is a long-term follow-up study of persons who have HIV and received their first treatment for HIV known as antiretroviral medications, in certain clinical trials that were done by the AIDS Clinical Trials Group (ACTG).

    Purpose of this Study: 

    The purpose of this study is to help us learn about how HIV , aging and the immune system (how your body fights infection) all interact with each other to see how they relate to the development of illnesses such as kidney disease, cancer, and diabetes. This study will also see if treating people with HIV for these otherillnesses works as well as treating people without HIV for the same illness.

    Requirements to Enter Study:

    -PersonsParticipants 40 years of age and older who werebeing actively followed in the ALLRT (A5001), or recently completed follow-up in ALLRT, at the time of enrollment in A5322.

    -Received their first HIV treatment in an ACTG protocol and then enrolled intothe ALLRT parent protocol.

    -Eligible participantspartcipants must agree to be followed long-term to observe the aging process and for outcomes known as endpoints that are either clinical (you have a disease or health problem), virologic (meaning how your HIV responds to treatment) or  immunologic (meaning how your immune system reacts)while taking long-term treatment with HIV medicine.

    -Planned enrollment to include approximately 22% female participantssex participants (corresponding to the

    proportion of female sex participantsparticipants aged 40 years and older being followed in the ALLRT study).

    -Ability to commit to the long-term study requirements.


    Treatment for HIV must be arranged outside of the A5322 protocol. No treatment is given through the A5322 protocol.

    Special Testing:

    -As in ALLRT, participants will have the Neuroscreen at entry into A5322 and every 48 weeks thereafter.  This includes both Neurocognitive testing (i.e., digit symbol, HVLT-revised) and Neuropathy testing (i.e., tendon reflexes and vibratory sensation testing). -In addition, there will be a frailty assessment which will be performed for all participants enrolled in A5322. This consists of a hand grip assessment (measure of hand strength) followed by a 4-meter timed walk , along with several interviewer-administered questions on weight loss, physical activity and exhaustion.

    -Participation in A5322’s substudy (A5323s: Inflammation in the Functional Capacity: Trajectory of those Aging with HIV-Infection [FIT Substudy]) which is Optional. Participants enrolled in both A5322 and A5323s will complete the entire physical function battery which is detailed below:

    Grip Strength (A5322 and A5323s)

    4-meter Walk (A5322 and A5323s)

    Single Chair Rise (A5323s only)

    Repeated Chair Stands (A5323s only)

    Standing Balance Test (A5323s only)

    400-meter Walk (A5323s only)

    Duration of Study:

    Participants will be followed for 366 weeks (7 years).

  • A5368:Anti-PD-1 Antibody in HBV Infected on Suppressive Antiviral Therapy

    January 24, 2020 Alexis Sexton

    “Safety and Immunotherapeutic Activity of Cemiplimab in Participants with HBV on Suppressive Antiviral Therapy: A Phase I/II Ascending Multiple Dose Study”

    Brief Description: Scientists are looking at ways to cure Hepatitis B (HBV). This study will assess the safety and tolerability of cemiplimab administered in participants with HBV on suppressive antiviral therapy.

    Purpose of this Study: This study is trying to find out if cemiplimab is safe and well tolerated. Participants will receive multiple dose levels (0.3, 1.0, and 3.0 mg/kg) of cemiplimab administered as two infusions at weeks 6 and 12.

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

    • Have chronic HBV infection (defined as HBsAg positive) and under treatment for ≥12 months with tenofovir- or entecavir-containing therapy: tenofovir disoproxil fumarate (TDF), tenofovir alanfenamide (TAF), TDF/emtricitabine (FTC), TAF/FTC, or entecavir.
    • Be willing to continue HBV antiviral therapy throughout the study.
    • Have certain tests done.
    • Agree to use contraception/birth control methods.
    • Be 18 years old or older but less than 70 years.
    • Weight ≥40 kg.
    • Had evidence of limited or no evidence of fibrosis (F0-F2) by liver biopsy or noninvasive alternative method.
    • Be willing to sign the consent after discussion with the research staff.

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

    • Positive for the presence of Hepatitis C Virus.
    • Received investigational drug or device within 60 days prior to study entry.
    • 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.
    • History of immunoglobulin IgG therapy or interferon (IFN) therapy within 12 months prior to study entry.
    • A male participant with a pregnant female partner.
    • Any vaccination within 30 days prior to entry.


    • Multiple dose levels (0.3, 1.0 and 3.0 mg/kg) of cemiplimab administered as two infusions at weeks 6 and 12.


    • Blood tests at clinic visits to check mainly hepatic and renal function.
    • Liver biopsy at study entry and at week 18 on study.
    • Leukapheresis for a group of participants.

    Duration of Study: Participants will be on study for up to 90 weeks (78 weeks following the last study drug infusion) with frequent safety evaluations.