• A5364: A Phase I, Open-Label Study of the Safety and Ability of Broadly Neutralizing Antibodies 3BNC117-LS and 10-1074-LS in Combination to Durably Prevent Viral Relapse During a Monitored Analytical Treatment Interruption

    October 10, 2022 Alexis Sexton

    ACTG A5364: A Phase I, Open-Label Study of the Safety and Ability of Broadly Neutralizing Antibodies 3BNC117-LS and 10-1074-LS in Combination to Durably Prevent Viral Relapse During a Monitored Analytical Treatment Interruption


    Treatment Category: Experienced


    Study Description
    This is a Phase I, open-label, single-arm, multi-step study designed to evaluate the effects of the combination of long-acting broadly neutralizing antibodies (bNAbs) 3BNC117-LS and 10-1074-LS in participants living with HIV who discontinue anti-HIV therapy (ART) during a monitored analytical treatment interruption (ATI), which is an extended period of time when not taking regular ART to control HIV.


    Study Status: Open to Accrual


    Why is this study being done?

    • To see if it is safe to give people 10-1074-LS and 3BNC117-LS, and to see if these study drugs cause any side
    • To evaluate the efficacy of the study drugs in preventing the return of HIV levels in the blood after interrupting ART.


    Who can join?

    • People with HIV between 18 and 70 years old.
    • On stable ART with an undetectable viral load for at least 48 weeks prior to study entry.
    • Body weight between 110 and 250 lbs.
    • Participants who can become pregnant must agree to use two methods of contraception during the
    • Be willing to temporarily stop taking ART medications.


    What do I need to do in the study?

    After screening, eligible participants will undergo leukapheresis (a procedure in which blood is collected from a vein in one arm, processed through an attached machine, and then returned through a vein in the opposite arm), and will be asked if they are interested in optional procedures (flexible sigmoidoscopy with rectal biopsy and/or lumbar puncture to collect spinal fluid). Three additional leukapheresis procedures will be done during the study.


    At study entry, participants will receive an infusion of 3BNC117-LS and an infusion of 10-1074-LS, and will discontinue ART 2 days later.


    Stopping ART is not recommended in the context of standard clinical care and poses some level of risk to the participant and sexual partner(s). However, for this research study, participants will be monitored closely while they are not taking ART. They will have to start taking ART again if blood tests show that it is necessary. The ATI can last up to 24 weeks of frequent visits to see if ART should be restarted.


    Each participant will be followed for 72 weeks.


    What treatments or drugs are involved with this study?

    10-1074-LS and 3BNC117-LS are antibodies to HIV. Many antibodies are naturally made by the body and help fight diseases. 10-1074-LS and 3BNC117-LS are made in a laboratory. They are called “monoclonal antibodies,” which means that they are made up of many copies of one single antibody.

  • A5418:Study of Tecovirimat for Human Monkeypox Virus (STOMP)

    September 9, 2022 Alexis Sexton

    ACTG A5418: A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease, Study of Tecovirimat for Human Monkeypox Virus (STOMP)


    Treatment Category: Monkeypox

    Study Description
    A5418 (STOMP) is a study of tecovirimat (also known as TPOXX) for the treatment of human monkeypox virus (HMPXV) disease.

    Study Status: Open

    Why is this study being done?

    • To see if tecovirimat is safe, and whether it helps treat monkeypox infection.

    Who can join?

    People with:

    • Laboratory-confirmed or presumptive monkeypox infection
    • Monkeypox illness of less than 14 days’ duration
    • At least one active (not yet scabbed) skin lesion, mouth lesion, or proctitis (inflammation of the lining of the rectum) with or without visible ulcers

    What do I need to do in the study?

    Participants will be randomly assigned (like flipping a coin) in a 2:1 ratio to receive tecovirimat OR placebo for tecovirimat for 14 days.

    People who are at higher risk for severe disease because of their age or their medical history will be assigned to receive open-label tecovirimat for 14 days.

    All participants will be followed through a combination of in-person visits, specimen collection, virtual assessments, and self-reports and photographs of symptoms for about 2 months.

    What treatments or drugs are involved with this study?

    Tecovirimat is a drug that may help to treat infections caused by pox viruses. Tecovirimat is approved by the Food and Drug Administration (FDA) to treat smallpox in adults and children, but its use in this study is considered investigational.

    Duration of Study

    57 days



    For more info: https://www.stomptpoxx.org/main

  • ACTG A5383: Randomized, Controlled Trial to Evaluate the Anti-inflammatory Efficacy of Letermovir (Prevymis) in Adults with Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive ART and Its Effect on Chronic Inflammation, HIV Persistence, and Other Clinical Outcomes (ELICIT)

    June 23, 2022 Alexis Sexton

    Brief Description:
    This study will include 180 participants. Participants will have HIV and Cytomegalovirus (CMV). CMV is common virus that many people living with and without HIV have been exposed to. You do not need to know if you have CMV to be considered for study participation. About half of the study participants will be given study medication to be taken once daily for 48 weeks. The study medication will be letermovir, an FDA approved medication to prevent CMV. The other half of
    participants will not receive any additional medication. The study will last about 1 year and 2 months.
    Purpose of this Study:
    To learn whether people living with well controlled HIV and symptom free CMV can reduce inflammation by taking a drug approved by the FDA to prevent CMV disease.
    To Enter the Study, the following must be true about you:

    • HIV positive, ≥40 years of age
    • On continuous anti-HIV medications for at least 48 months with no interruptions >7 days
    • At least 48 months of undetectable viral loads, although a one-time, low-level viral load is OK
    • Have not made significant change in HIV medication in the past 12 weeks, or plan to make changes during study participation
    • No heart arrythmias/ irregular heart beats
    • No active Hepatitis B or hepatitis C within 24 weeks
    • Not currently using any of the following HIV medications: efavirenz, nevirapine, etravirine, lopinavir/ritonavir, or once a day dosing of raltegravir (twice a day dosing is OK)
    • While people with any CD4 count are eligible, the study is particularly interested in recruiting people with low CD4 counts (i.e., <350 cells/mm3)
    • While people of all gender identities are eligible, the study is particularly interested in recruiting cis-gender women and transgender women receiving gender-affirming hormones

    There will be treatment provided in this study. Letermovir is a pill given by mouth once a day that is FDA-approved to prevent CMV disease. There are two study treatment groups.
    You will have a 50/50 chance of going into one of the two groups. Participants in one group will get letermovir and participants in the other group will not get any additional medications.

  • A5355: Phase II, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®) in Adults with Both Human Immunodeficiency Virus (HIV)-1 and CMV Who Are on Potent Combination ART with Conserved Immune Function

    June 2, 2022 Alexis Sexton

    Brief Background and Description: Since the early days of the HIV epidemic cytomegalovirus (CMV) has been one of the most common and devastating opportunistic infections (OIs) experienced by people with HIV. CMV is a common virus that usually causes few, mild, or no symptoms and typically remains in the body for life; in people with weakened immune systems, however, CMV can cause more serious symptoms affecting the eyes, lungs, liver, esophagus, stomach, and intestines ). HIV and CMV can work together against our bodies’ defenses, making transmission of each virus easier. We would like to change this.

    In this study, you will be randomized to one of the study treatment arms. You will receive either Triplex® study vaccine or placebo by injection into the muscle of your shoulder 2 times; once when you enter the study and again about 4 weeks later.

    Purpose of this Study: The purpose of this study is to see if an investigational vaccine for CMV (called Triplex®) is safe when given to people with both HIV and CMV. This study will also collect information on the effectiveness of Triplex® to reduce inflammation and immune activation markers compared to a placebo. This will be the first time that this type of information will be collected. You should be aware that the current standard of care for individuals with both HIV and CMV includes effective treatment for HIV but does not include treatment of CMV with either medication or vaccination – unless there is evidence that the CMV is causing or contributing to illness.

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

    • Living with HIV-1 and with cytomegalovirus (CMV).
    • Be between 18 and 65 years old.
    • On an anti-HIV medications that are controlling your HIV for at least the past year.
    • Agree to use contraception/birth control methods if capable of becoming pregnant or impregnating someone else.

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

    • Use of anti-CMV drugs within the past 2 weeks.
    • Currently have hepatitis B or hepatitis C
    • Currently have a sexually transmitted infection (such as, gonorrhea, syphilis, or chlamydia)
    • History of CMV disease and symptoms within the past 12 months.
    • Receipt of any vaccine (including for COVID-19) within the previous 4 weeks.
    • 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.

    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 two study groups. You will have double the chance of receiving Triplex® versus the placebo. You must continue to take your anti-HIV drugs throughout the study.


    • Blood and urine tests at scheduled clinic visits for safety evaluations and other research testing.
    • Questionnaires asking for information on adherence to ART and use of other drugs.
    • For 4 weeks following each study injection you will complete a daily study diary (which is also known as a study vaccination report card); you will need to take and record your body temperature for the first 5 days each time.
    • At several of the clinic visits, saliva, rectal swabs, and/or genital fluid (semen or vaginal swab) will be collected.

    Duration of Study: About 2 years (96 weeks). In the first month of the study, you will have 2 study visits and 2 telephone contacts with clinic staff. After that, you will have 5 more visits over the next 16 months. After you have been on the study for about 2 years (about 4 months after your last study visit), your participation will end with a phone call from the clinic staff.

  • A5404: SARS-CoV-2 Immune Responses after COVID-19 Therapy and Vaccine

    July 23, 2021 Alexis Sexton

    Right now there is no medicine proven to treat COVID-19 in people who are not sick enough to be hospitalized. Researchers will be testing different investigational medicines that they believe are most likely to help people with COVID-19.

    They want to see if these investigational medicines:

    • Are safe for those who need them
    • Can help people get better faster
    • Can get rid of the virus
    • Can help keep oxygen levels up
    • Can keep people from getting sicker
    • Can prevent people from having to go to the hospital

    The whole study lasts about 6 months (24 weeks).

    During the study you would have in-person visits with tests to check on your health. Most of these visits happen during the first month of the study.

    You would also have phone calls or videos chats with the researcher from your home.

    The study team will give you a diary to keep track of your temperature each evening and any symptoms you have. You’ll be asked to fill out this diary for the first 28 days.

    If the study is right for you, you will have your first visit, or entry visit, to meet with a researcher for tests and to be placed in a treatment group.

    Each study medicine will be compared to a placebo. A placebo looks like the real drug but doesn’t have any actual medicine in it. This gives researchers something to compare the study medicine to. You would not know if you are receiving the study medicine or placebo until the end of the study. If a standard treatment for COVID-19 is found during the study, that treatment will be used instead of placebo. Different medicines may be tested during the study at the same time. One type of investigational medicine you might receive is called a monoclonal antibody. Antibodies are naturally made by your body to help fight disease. Monoclonal antibodies are made in the lab and help your body attack invaders, such as viruses, to keep them from entering your cells. Once you are placed in a treatment group, you will receive more information on that investigational medicine being tested, including any possible side effects.


    To learn more about this study click here.

  • 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

    ACTG A5391: Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study)


    Treatment Category:  Treatment Experienced


    Study Description

    Weight gain after starting HIV therapy is common, but recent studies have found that some people with HIV (PWH) who are taking an integrase inhibitor (INSTI) combined with a tenofovir alafenamide (TAF) regimen may gain more weight than people taking other drug combinations.  A rising number of PWH are overweight or obese, and a higher body mass index (BMI) increases the risk for diabetes, heart disease and stroke.


    This study will include PWH who have been virally suppressed on a regimen consisting of an integrase inhibitor (INSTI) and TAF/FTC or TAF/3TC, and have a BMI of 30 kg/m2 (the cut-off for obesity) or greater. This research study is trying to find out if they could gain less weight, or maybe lose weight, after switching to a regimen containing doravirine (DOR) with TAF/FTC (or TAF/3TC), or DOR with the related medication tenofovir disproxil (TDF/FTC [or TDF/3TC]) as compared to continuation of their current INSTI plus TAF regimen.

    Study Status 

    Why is this study being done?


    • To see if obese PWH on an INSTI-containing regimen can either reduce their rate of weight gain over time or even lose weight with a change to a different regimen.


    Who can join?


    • People living with HIV-1 who are at least 18 years of age
    • Currently on an Integrase Inhibitor (INSTI) containing regimen (bictegravir, dolutegravir or raltegravir) plus TAF/FTC (or TAF/3TC) for at least 48 weeks
    • HIV viral load less than 50 copies
    • Have a body mass index (BMI) at least 30 kg/m2.
    • No plans to undergo weight loss surgery or to start significant exercise, diet, or medications affecting weight (e.g., structured weight loss programs such as Weight Watchers)


    What do I need to do in the study?


    Participants will be randomized to one of three study groups:

    Group 1: DOR and continue taking TAF/FTC (or TAF/3TC)

    Group 2: DOR and switch TAF to TDF/FTC (or TDF/3TC)

    Group 3: Continue current INSTI+TAF/FTC (or TAF/3TC)


    Study procedures include blood and urine tests, questionnaires about adherence to medications, diet and exercise habits, and DEXA Scans to measure lean muscle, body fat and bone density.


    Duration of Study:

    Participants will be on study treatment for 48 weeks.  Follow-up visits occur at Weeks 4,12,24,36, and 48.


    What treatments or drugs are involved with this study?

    Doravirine, which 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, will be provided by the study.


    NRTIs will need to be obtained by prescription from primary care provider.



  • 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


    • Semaglutide subcutaneous injection once weekly for 24 weeks.


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

    Duration of Study: Approximately 48 weeks