• A5395: A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons with COVID-19

    April 23, 2020 Alexis Sexton

    Study Description

    COVID-19 is a new illness caused by the severe acute respiratory syndrome coronavirus (SARS CoV-2). There is currently no vaccine to prevent SARS-CoV-2 infection, or medicine proven to treat COVID-19. Therefore, there is an urgent public health need for rapid development of new therapies. A5395 is a clinical trial designed to compare the efficacy of hydroxychloroquine (HCQ) plus azithromycin (Azithro) versus placebo in symptomatic adult outpatients with COVID-19.

    Why is this study being done?

    • To see if hydroxychloroquine (HCQ) and azithromycin (Azithro) treatment will prevent hospitalizations and death in adults with COVID-19.

    Who can join?

    Persons who:

    • Are 18 years of age or older
    • Have a positive test for COVID-19 from a nose or throat specimen collected within 96 hours prior to when the first dose of study treatment is expected to be taken
    • Are experiencing at least one of the following symptoms within 24 hours: fever, cough, or shortness of breath
    • Have no need for hospitalization
    • Agree not to participate in another COVID-19 study, unless if hospitalized

    What do I need to do in the study?

    The study is designed to minimize in-person contact between participants and study staff. The informed consent process, screening, study entry, and follow-up may be performed remotely or in person.

    At study entry, participants will have an in-person or remote (for example, video) study visit, and will receive a study kit (which will include enough pills for the whole course of study treatment) and a diary in which to record symptoms and when study medications are taken. Participants will provide medical and medication histories, contact information, complete the first day of their symptom and medication diary, and take their first dose of study treatment.

    Study staff will contact participants by phone on Days 2, 4, 6, 9, 13, and 17, and at 3 and 6 months after they enter the study. At each visit, participants will be asked how they have been feeling healthwise, review their symptoms and treatment, and record any hospitalizations or urgent visits to emergency rooms or clinics. Participants will return their symptom diary by mail or in person on Day 20. At select sites, participants will have the option of having a blood draw, a nose-throat swab, and a self-collected nose swab at study entry and on Days 6 and 20 (in-person visits).

    What treatments or drugs are involved with this study?

    Participants will have a 50/50 chance of receiving either active or placebo study treatment, as follows:

    • Hydroxychloroquine/Placebo two (200 mg each) capsules by mouth twice on the first day, and then one (200 mg) capsule twice a day for 6 days


    • Azithromycin/Placebo two (250 mg each) capsules by mouth once on the first day, and then one (250 mg) capsule every day for 4 days.

    Treatment will be for 7 days, with 23 weeks of follow-up.


    Para ver esta información en español, oprima aquí

  • 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

  • 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.

  • 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.


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


    • 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.

  • 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.

  • A5324: A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification with Maraviroc and Dolutegravir with No Intensification or Intensification with Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV 

    February 11, 2020 Alexis Sexton

    A5324 is a study for persons with HIV with undetectable HIV viral load who have mild neurocognitive impairment. Participants will be randomized (like a flip of a coin) to one of three study arms to add either placebo (sugar pill) for maraviroc (MVC) and placebo for dolutegravir (DTG) (Arm A), DTG active drug and placebo for MVC (Arm B), or MVC and DTG active drugs (Arm C) to their existing HIV treatment known as antiretroviral therapy (ART).

    Participants will be assessed with neurocognitive tests (test of how well your brain is working) and questionnaires about their daily life functions. There is an option to undergo lumbar punctures (spinal tap to test the fluid that surrounds the brain).

    Purpose of this Study:

    The main purpose of the study is to see if adding on MVC and/or DTG will improve neurocognitive performance and functioning in participants who have at least mild neurocognitive impairment and have an undetectable viral load. Safety and tolerability of MVC and DTG when added to a stable ART regimen and the effect of the study drugs on markers in the blood and spinal fluid will also be studied.

    Requirements to Enter Study:

    • Men or women with HIV at least 18 years of age
    • On current ART for at least 12 months
    • Undetectable HIV viral load (meaning <50 copies/mL on blood testing)
    • No more than one viral load test between 50 and 200 copies/mL (only one “blip”) in the past 6 months
    • At least mild HIV-associated neurocognitive impairment on neurocognitive tests done at screening
    • Able to complete the neuropsychological tests in English
    • No medical problem not related to HIV that may cause cognitive impairment
    • No current hepatitis C
    • No prior or current use of any integrase inhibitor or MVC
    • No active syphilis or treatment for syphilis

    Study Drugs

    Participants will be randomized (1:1:1 like a flip of a coin) to add one of the following regimens to their existing


    Arm A: placebo for MVC and placebo for DTG

    Arm B: DTG and placebo for MVC

    Arm C: MVC and DTG

    Neuropsychological testing will be done at entry and every 24 weeks.

    A subset of participants will have optional lumbar punctures at entry and week 48.

    Duration of Study: 96 weeks

  • 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).

  • A5375: Optimize LNG EC

    May 17, 2019 pendari

    Will determine if a higher dose of levonorgestrel Emergency Contraception (commonly called “Plan B” or the “Morning After Pill”) is needed to achieve high enough drug levels in girls and women who are taking anti-HIV medications that are known to decrease the effectiveness of this form of birth control.

    Treatment Category: Treatment Experienced

    Study Description
    This study will determine if a higher dose of levonorgestrel Emergency Contraception (LNG EC) (commonly called “Plan B” or the “Morning After Pill”) is needed to achieve high enough drug levels in girls and women who are taking medications that are known to decrease the effectiveness of this form of birth control.

    Efavirenz and rifampin, two medications commonly used to treat HIV and tuberculosis (TB), are known to lower the amount of LNG in the blood when LNG is used as a daily birth control pill. Dolutegravir, which does not lower the drug levels of LNG, will be the standard (control) group to which the other groups will be compared.

    Women who are receiving efavirenz will be randomized to take either the standard or double dose of LNG EC. Women on rifampin will take a double dose of LNG EC, while the control group on dolutegravir will take the standard LNG EC dose. Drug levels will be evaluated after taking one dose of LNG EC.

    Why is this study being done?

    • To see if participants who take a double dose of LNG EC and are on efavirenz or rifampin have similar drug levels as women who take the standard dose.
    • To see if a double dose of LNG EC is safe compared to the standard dose

    Who can join?

    • Females ≥16 years of age who have started menstruating
    • Not currently pregnant, within 6 weeks of delivery, or currently breastfeeding
    • Agree to use an approved non-hormonal birth control method during the study
    • Currently taking either efavirenz, dolutegravir, or rifampin
    • Have either HIV infection or an active TB infection

    What do I need to do in the study?
    All participants will receive one standard or double dose by mouth, depending on which medication they are currently receiving:

    Efavirenz: Randomized to either the standard dose (1.5 mg) or a double dose (3 mg) of LNG EC
    Rifampin: Double dose (3 mg) of LNG EC
    Dolutegravir: Standard dose (1.5 mg) of LNG EC

    At entry, participants will take their assigned standard or double dose of LNG EC and have their blood drawn nine times over about 9 hours. They will return to the clinic for blood level sampling after 24 and 48 hours, and will then be contacted by phone at weeks 1, 2, and 4.

    What treatments or drugs are involved with this study?
    The study treatment that will be provided through the study is levonorgestrel EC. Anti-HIV and TB medications will not be supplied through this study.

  • A5345: HIV Rebound & Control Biomarkers

    May 17, 2019 pendari

    Uses data collected during intensively monitored antiretroviral pauses, where participants stop taking anti-HIV medications until they meet criteria for restarting them. The study is testing for the presence of biomarkers that predict certain events, including when HIV will be “seen” again in blood after stopping anti-HIV medications and when it will be controlled again after re-starting medications.

    Treatment Category:

    Treatment Experienced

    Study Description

    This study uses an intensively monitored antiretroviral pause (known as an IMAP) in which participants stop taking anti-HIV medications until they meet criteria for restarting them. Blood will be collected at various time points and then tested for the presence of biomarkers that can predict certain events, including when HIV will be “seen” again in blood after stopping anti-HIV medications (this is known as “rebounding”) and when HIV will be controlled again after re-starting anti-HIV medications.

    Why is this study being done?

    • To collect blood samples that can help to find and develop tests that can predict when HIV will rebound after people interrupt their anti-HIV medications and when HIV will be controlled again after anti-HIV medications are re-started.
    • To study changes in HIV reservoirs (places where HIV “hides”) after anti-HIV medications are stopped.

    Who can join?

    • HIV infected men and women, 18 to 70 years old
    • On anti-HIV medications with undetectable HIV viral load for at least 2 years
    • CD4 at least 500 now, and never had a CD4 less than 200
    • Must be willing to stop and restart anti-HIV medications

    What do I need to do in the study?

    During the IMAP, participants will have frequent visits (beginning at twice per week and possibly decreasing to once every two weeks) and frequent checks for HIV in their blood. Participants will be closely monitored so that anti-HIV medications can be restarted as soon as they need to be. The study will involve the collection of large amounts of blood and at least one leukapheresis procedure.

    The length of time on study will depend on if and when HIV rebounds during IMAP, and how long it takes for the HIV to be controlled again after anti-HIV medications are restarted. Most participants will likely be on study for 1 year or less.

    What treatments or drugs are involved with this study?

    Participants must be taking anti-HIV medications, except during the IMAP. The anti-HIV medications will not be supplied through this study. Some people may have to switch their anti-HIV medications at the beginning of the study.

    Is there anything else I need to know about this study?

    Separate but related fluid and tissue samples will be collected in a substudy of A5345 known as A5347s (Reservoir Sampling Substudy of A5345). Participants will undergo different types of procedures to help understand how and where HIV might remain even though the level of HIV in their blood has been very low. See below.

    A5347s: Anatomic Reservoir Substudy of A5345

    Why is this substudy, A5347s, being done?

    The main goal of this substudy is to collect samples from multiple anatomic compartments at as many of the following A5345 time points as possible:

    • before the antiretroviral pause (in A5345 Step 1)
    • very close to the time of virologic rebound (in A5345 Step 2)
    • shortly after completion of 24 weeks off antiretroviral treatment (ART) for any participants who reach this time point (in A5345 Step 2) without meeting any ART re-initiation criteria

    This substudy will compare samples from different reservoirs to learn more about the following:

    • Where HIV can be found.
    • Whether the amount of HIV is different in different reservoirs.
    • What the best way is to measure the amount of HIV in different reservoirs.
    • Whether the amount of HIV found in any one reservoir can tell us anything about the amount of HIV in any of the other reservoirs.
    • Whether it could become possible to predict what will happen when a person stops taking ART.

    Study Status

    The substudy is open to accrual

    Who can join the substudy, A5347s?

    A5345 participants are eligible to enroll in the A5347s substudy if they:

    • Agree to undergo at least one rectal biopsy (tissue collection from the rectum)

    There will be two groups of participants in the substudy. Category 1 is for A5345 participants with a Step 1 week 4 plasma HIV-1 RNA level of <20 copies/mL. Category 2 is for A5345 participants who complete 24 weeks on Step 2 of A5345 without meeting ART re-initiation criteria.

    What do I need to do in the substudy, A5347s?

    Participants will undergo one or more of the following procedures:

    • RB Sampling Group – rectosigmoidal biopsies by flexible sigmoidoscopy (all participants must be in this group)
    • LN Sampling Group – lymph node biopsies
    • CSF Sampling Group – collection of cerebrospinal fluids by lumbar puncture
    • GTS Sampling Group – collection of genital tract secretions

    How long will I be in A5347s?

    The duration of the substudy will depend on events in A5345 and on which group (or category) you are in. Category 1 participants could be in the substudy for 2 to 3 months or could remain in substudy for more than 2 years if they agree to CSF collections. Participants who enter A5347s as Category 2 participants could be in the substudy for as little as 4 weeks or, if they agree to CSF collections, for more than 2 years.