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Study of Emtricitabine, Tenofovir Alafenamide and Bictegravir in Adults with HIV Undergoing Analytical Treatment Interruption

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on people living with HIV, a virus that attacks the immune system. Participants will receive an oral medication that combines two active substances, emtricitabine and tenofovir alafenamide, which are commonly used to keep the virus suppressed.

The purpose of the study is to determine whether individuals with a favorable genetic and clinical background can maintain low levels of the virus after stopping medication. After an initial treatment period, the medication will be stopped in a process called analytical treatment interruption, and participants will be closely monitored for up to 24 weeks. Blood tests will measure the viral load (the amount of virus in the blood) and will also look at immune cells such as CD4 and CD8 lymphocytes and NK cells; laboratory techniques like flow cytometry and NGS will be used to study these cells and the virus that remains hidden in the body.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment (week 0)

    You attend the first study visit after joining the trial. a series of tests are performed to collect information about your health and the virus.

    Blood samples are taken to measure viral load (the amount of virus in the blood), to evaluate the size of the viral reservoir, and to analyze immune cells such as cd4 and cd8 lymphocytes.

    Genetic and phenotypic tests are done to determine if you have the favourable background that the study is looking for.

    The study medication, which contains emtricitabine and tenofovir alafenamide, is explained. it is taken by mouth; the exact dose and schedule are defined by the study protocol.

  2. Step 2

    Start of analytical treatment interruption

    After the baseline visit you stop your regular antiretroviral therapy as instructed by the study team. this period without medication is called analytical treatment interruption.

    You continue to take the study medication (emtricitabine and tenofovir alafenamide) orally as directed for the duration specified by the protocol.

  3. Step 3

    First follow‑up visit (week 4)

    You return to the clinic four weeks after stopping your regular therapy.

    Blood is drawn to check viral load, to assess the viral reservoir, and to perform immune‑cell analyses such as flow‑cytometry.

    Questions are asked about any symptoms or signs of retroviral syndrome.

    The study medication is continued according to the schedule.

  4. Step 4

    Second follow‑up visit (week 8)

    At eight weeks you have another clinic visit.

    Blood samples are collected to measure the generation of autologous neutralizing antibodies and to monitor inflammation markers.

    You are asked about any new symptoms.

    The oral study medication is taken as prescribed.

  5. Step 5

    Third follow‑up visit (week 12)

    During the twelve‑week visit, further blood draws are performed for viral load, viral reservoir assessment, and detailed immune‑cell studies including cd4, cd8, and nk cell activity.

    Additional laboratory tests evaluate cytokine levels and transcriptional changes in lymphocytes.

    The study medication continues to be taken orally.

  6. Step 6

    Fourth follow‑up visit (week 24)

    At twenty‑four weeks, the primary endpoint of the study is evaluated.

    Blood is drawn to determine if viral load is below 50 copies per milliliter, which is the target for viral control.

    Comprehensive measurements of the viral reservoir, immune responses, and inflammation markers are repeated.

    The oral study medication is maintained as instructed.

  7. Step 7

    Fifth follow‑up visit (week 36)

    The thirty‑six‑week visit includes repeat blood tests for viral load, viral reservoir size, and immune‑cell function.

    Additional analyses look at cytotoxic activity of cd4, cd8, and nk cells, as well as transcriptomic profiling.

    You continue taking the study medication according to the protocol.

  8. Step 8

    Final follow‑up visit (week 48)

    The last study visit occurs forty‑eight weeks after the start of the interruption.

    Final blood samples are collected to assess long‑term viral control, reservoir characteristics, immune response, and any remaining symptoms.

    The study medication is taken until the end of the scheduled period.

    After this visit the trial participation is concluded.

Who can join the trial?

8 criteria

  • Be a man or woman between 18 and 65 years old, have been screened in the earlier study, and sign a written consent form.
  • Have a favorable genetic makeup (genotype) and a favorable natural‑killer (NK) cell profile, which means having specific immune markers (certain HLA types and more than 16% of NK cells showing CD57+, NKG2C, KIR3DL1 and KIR2DL3 markers).
  • Be on active antiretroviral treatment (ART) for at least 2 years (the medicines used to keep HIV under control).
  • Have an undetectable viral load (VL) at the time of joining the study and during the planned treatment break (the amount of virus in the blood is so low it cannot be measured).
  • Have a CD4 count of 500 cells per microliter or higher at the start of the treatment break (CD4 cells are a type of immune cell that HIV attacks).
  • Have a lowest-ever (nadir) CD4 count of at least 200 if diagnosed very early, or at least 350 if diagnosed later.
  • Agree to follow recommended HIV prevention practices (such as safe sex and not sharing needles).
  • If you could become pregnant, you must have a negative pregnancy test (blood or urine) before joining the study.

Who cannot join the trial?

13 criteria

  • You cannot be pregnant (expecting a baby) or breastfeeding (feeding a baby with your milk).
  • You must not have received broadly neutralising antibodies (special medicines that target many strains of HIV) in the past 2 years.
  • You cannot have had two or more viral load (VL) tests showing more than 50 copies of HIV per milliliter in the 2 years before the study.
  • You must not be taking any immunosuppressive medication (drugs that lower the strength of your immune system).
  • If you are a man or a woman who could become pregnant, you must be willing and able to use a very effective form of birth control for the entire study period.
  • You cannot have an active infection with HBV (hepatitis B virus) or HCV (hepatitis C virus).
  • You must not have had any past or current opportunistic infection (infections that take advantage of a weakened immune system), such as CMV retinitis (eye infection) or cryptococcal meningitis (brain infection).
  • You cannot have serious heart, kidney, or liver disease that is active or significant.
  • You must not have any current cancer of any type, nor any history of cancer related to HIV.
  • You cannot have an active or hidden (latent) infection with tuberculosis (TB).
  • You must not have any other major health problem that the doctor thinks could become worse if HIV is not fully controlled.
  • You cannot be currently using or have used before a long‑acting injectable ART (a long‑lasting injection of HIV medicine).
  • You must not have a history of HIV medicine resistance that leaves you with no other treatment options.
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Investigated drugs

Emtricitabone, Tenofovir Alafenamide and Bictegravir is an oral tablet that combines three medicines used to treat HIV. The first two parts, emtricitabine and tenofovir alafenamide, belong to a group of drugs that block the virus from copying its genetic material. The third part, bictegravir, works by stopping a different step the virus needs to grow. In this trial, the tablet is being given to participants who temporarily stop their regular HIV treatment, to see if this combination can keep the virus at very low levels without the need for continuous medication.

What is already known about the treatment

Emtricitabine, Tenofovir Alafenamide and Bictegravir - The medication is taken orally as a single tablet. It is an approved and widely used treatment for HIV infection. Emtricitabine and tenofovir alafenamide are nucleoside reverse transcriptase inhibitors that block the virus from copying its genetic material, while bictegravir is an integrase strand transfer inhibitor that prevents the virus from inserting its DNA into human cells. The combination is classified as a fixed‑dose antiretroviral regimen.

Investigated diseases

HIV - HIV (human immunodeficiency virus) is a virus that infects immune cells called CD4 lymphocytes. After infection, the virus replicates and reduces the number of CD4 cells, weakening the body's ability to fight infections. Over time, the loss of CD4 cells can lead to a gradual decline in immune function. Without control, the infection can progress from an initial acute phase to a chronic stage where the immune system becomes increasingly compromised.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526395-23-00Protocol codeCLINIC-CUREEstimated enrolment20 patientsSponsorFundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

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