• 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.

  • 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

  • A5312: The Early Bactericidal Activity of High Dose or Standard Dose Isoniazid among adult Participants with Isoniazid-Resistant or Drug Sensitive Tuberculosis

    August 31, 2020 Alexis Sexton

    This study is for participants who have pulmonary tuberculosis (TB), a bacterial infection in their lungs. Isoniazid (INH) is a drug commonly used to treat TB. Sometimes, the bacteria that cause TB can become resistant to INH, and then INH does not work as well at fighting the bacteria. This study will treat people with INH-resistant TB with different doses of INH to see if INH can still fight the bacteria if we just increase the dose.


    We will compare how well the drug works at higher doses for participants who have resistant TB to how well the drug works at regular doses for participants who have TB that is sensitive to the drug. The study will also compare the safety and tolerability of the different doses of INH.

    Study Stages

    If you join this study, you will need to be admitted to the hospital for at least 9 days. If you have not stopped taking INH you may need to be admitted for longer (up to 16 days in total) so that there is time for the INH to wash out of your body. While you are in the hospital, you will be asked to collect the sputum that you cough up in a container. Seeing how many bacteria are in the sputum you cough up will help us to know how well the medicine is working. After you are discharged from the hospital, you will come to the clinic 14 days later for a final visit.

    If you meet the eligibility requirements for the study, you will have a test to see if you have INH-resistant TB, and if it is low-level or high-level resistance. (With low-level resistance, the bacteria are not as resistant to INH as they are with high-level resistance.) You may also be asked to provide sputum for other types of resistance tests.

    Depending on the test result, you will be assigned to one of 3 groups:

    • If you have low-level INH resistance, you will either be referred to receive standard TB treatment outside of the study or be randomized (like a flip of a coin) to receive 5, 10 or 15 mg/kg INH once a day for 7 days. Randomized means that you have equal chance of being in any of these 3 groups. (Mg/kg, or milligrams per kilogram, means the amount of INH in milligrams you will receive for each kilogram you weigh.)
    • If your test shows no INH resistance, you will either be referred to receive standard TB treatment outside the study or you will receive 5 mg/kg INH once a day for 7 days.
    • If you have high-level resistance, you will either be referred to received standard TB treatment outside the study or you will be randomized to receive 15 or 20 mg/kg INH once a day for 7 days.

    INH will be provided for you. In addition, you must also take vitamin B6 once a day while taking INH, to help prevent possible side effects of INH. Vitamin B6 will also be provided to you. When you are finished taking study drug, you will be referred for full TB treatment outside the study.

    Inclusion Criteria:

    • New or current pulmonary TB
    • Adults between the ages of 18 and 65

    Exclusion Criteria

    • Known exposure to extensively resistant TB (XDR-TB)

    Duration of Study: About 23 days

    Total number of participants: Between 128 and 218

  • A5401: ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies

    July 21, 2020 Alexis Sexton

    Study Description:

    A master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with COVID-19. It begins with a phase II evaluation, followed by a transition into a larger phase III evaluation for promising agents.

    Why is this study being done?

    To rapidly and efficiently evaluate multiple potential therapeutics for COVID-19 in an outpatient setting.

    Who can join?

    • Ambulatory Adult (18 years or older)
    • Active SARS-CoV-2 infection <7 days prior to Entry
    • At least one typical COVID-19 symptom for <10 days prior to Entry, plus one the following symptoms present within 48 hours of entry:

    –Fever or feeling feverish, cough, shortness of breath at rest or with activity, sore throat, body or muscle pain, fatigue, headache, chills

    • Tailored per study agent requirements

    Duration of study: 28 days of intensive follow-up, followed by limited follow-up through 24 weeks.


    To find more information click here and to see our press release relating to this study click here.

  • 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

  • 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.

  • 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.

  • A5366: Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation with Histone Deacetylase Inhibitors

    February 11, 2020 Alexis Sexton

    While antiretrovirals known as ARV’s (group of medicines used to treat HIV) have provided very effective treatment of HIV, cure of HIV from the body has not been possible.  One of the reasons may be due to virus hiding in resting (or ‘latent’) immune cells. This reservoir (the hidden virus) is able to reproduce itself and serves as source of infection if ARV’s are stopped. Some investigational medications have been shown to wake up latent (sleeping) immune cells allowing them to get rid of the virus they have inside them. However, these therapies are only partly effective and results vary in different people. Preliminary studies have shown that these therapies may be less effective in women due to female hormones.

    This study will evaluate one of the medications (Vorinostat) that have been shown to reverse latency in combination with another medication (Tamoxifen) that researchers hope will enhance that effect, specifically in women.

    Purpose of this Study: 

    The primary purpose of this study is to see if Tamoxifen given with Vorinostat is safe. It will also study if Tamoxifen will enhance the ability of Vorinostat to reverse latency in post-menopausal women.

    Basic requirements to Enter Study:

    • HIV-1 positive women between 18 and 65 years of age (up to 66th birthday)
    • Post-menopausal (either >18 with both ovaries removed or >40 with no period in the last 2 years)
    • CD4 count >300 cells/mm3 (CD4 cells are a kind of white blood cell that are a measure of the immune system)
    • On ARV’s for at least 2 years with undetectable viral loads
    • No active Hepatitis B or C
    • No history of cancer, blood clot or stroke
    • Not currently smoking or taking hormonal therapy


    At entry, participants will be randomized to receive open label Tamoxifen 20mg by mouth daily (20 participants), or no Tamoxifen (10 participants) for the first 5 weeks. All participants will then receive 2 doses of 400mg each Vorinostat by mouth separated by 72 hours.

    Duration of Study:

    Up to 9 weeks per participant after a screening period of up to 90 days.

  • 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.