ClinicalTrials.gg
Not yet recruitingNCT07875504CLINIC-CUREUpdated Oct 15, 2026

A Clinical Trial of Analytical Treatment Interruption in People With HIV With a Highly Favourable Profile

An interventional study of Treatment interruption in HIV, sponsored by Fundacion Clinic per a la Recerca Biomédica. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Fundacion Clinic per a la Recerca Biomédica · Not applicable, Interventional, and Treatment

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

A pilot single exploratory clinical trial of ATI in a selected sample of PWH sharing specific genetic, phenotypic and clinical characteristics.

02

Conditions studied

  • HIV
03

In context

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica is the lead sponsor of 64 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Men or women aged 18 and ≤65 years old who were screened and pre-selected in the exploratory study HCB/2023/0510 and who provide written to participate.
  2. Having a favourable genotype AND a favourable NK phenotype defined by

    1. the presence of HLAB35 +, Bw4 > 1 + 2 threonine or HLA Bw4 > 2 + 2 threonine AND
    2. the presence of a percentage > 16% in NK memory-like cells displaying CD57+, NKG2C, KIR3DL1 and KIR2DL3 markers.
  3. On active ART for a minimum of 2 years.
  4. Undetectable VL at the moment of inclusion and ATI.
  5. ≥500 at the moment of ATI.
  6. CD4 T cell count nadir ≥ 200 (for people who was diagnosed in primary infection) and ≥ 350 (for chronic infections).
  7. Participant agrees to follow preventive practices.
  8. Women of * must have a negative pregnancy test in serum or urine before the inclusion in the study.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or breastfeeding.
  2. Active or co-infection (defined by positive HBs Antigen and positive HCV-RNA)
  3. Past or current evidence of severe opportunistic infection such as CMV retinitis or cryptococcalmeningitis.
  4. Active or substantial cardiovascular, kidney or liver disease.
  5. Current cancer of any type or any history of -related cancer.
  6. Active or latent tuberculosis infection.
  7. Any significant co-morbidity at discretion of the investigator that may be jeopardized in case of incomplete HIV viral suppression.
  8. Current or previous use of Long-acting injectable ART.
  9. History of antiretroviral drug resistance and no other options beyond their current regimen.
  10. Receipt of broadly neutralising antibodies within the past 2 years.
  11. 2 or more VL determinations > 50 copies/ml in the 2 years previous to ATI.
  12. Any concomitant medication.
  13. Men or women of unable or unwilling to use highly efficient measures** from the beginning until the end of the study.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Treatment interruption

    Antiretroviral treatment interruption in people with HIV with a highly favorable profile

    Other: Treatment interruption

Interventions

  • OtherTreatment interruption

    Antiretroviral treatment interruption in people with HIV with a highly favorable profile

06

What researchers measure

Primary outcomes

  1. Proportion of individuals with VL<50 copies.

    Time frame: At 24 weeks of ATI

Secondary outcomes

  1. To determine the proportion of patients with partial viral control up to 24 weeks (< 200, < 400 and <1000 copies/ml) of ATI.

    Proportion of participants with VL \< 200, \<400 copies/ml and VL \<1000 copies/ml

    Time frame: At 24 weeks post-ATI

  2. To determine time to rebound after ATI.

    Time (in weeks) to viral rebound (VL≥ 50).

    Time frame: From the start of Analytical Treatment Interruption (ATI) up to 24 weeks.

  3. Proportion of participants with clinical symptoms during Analytical Treatment Interruption (ATI).

    Percentage of participants experiencing any clinical symptom or retroviral syndrome during ATI.

    Time frame: From the start of Analytical Treatment Interruption (ATI) up to 24 weeks.

  4. To study the HIV reservoir.

    Evolution of the viral reservoir as measured by IPDA and intracellular viral RNA.

    Time frame: At weeks 0, 4, 12, 24, 36 and 48.

  5. To study viral inhibition in CD4 counts.

    Viral inhibition "in vitro" (VIA assays) culturing CD4 lymphocytes in the presence of CD8 and/or NK lymphocytes.

    Time frame: At weeks 0, 4, 12, 24., 36 and 48.

  6. Percentage of senescent CD8+ T lymphocytes

    Change from baseline in the percentage of senescent CD8+ T cells (defined as CD8+CD57+) out of the total CD8+ T lymphocyte population, assessed by flow cytometry.

    Time frame: At weeks 0, 4, 12,24, 36 and 48.

  7. Percentage of memory-like Natural Killer (NK) cells.

    Change from baseline in the percentage of memory-like NK cells (defined by the expression of CD57+CD56+dim, NKG2C+, and KIR3DL1+) out of the total NK cell population, assessed by flow cytometry.

    Time frame: At weeks 0, 4, 12, 24, 36 and 48.

  8. Percentage of gamma-delta (γδ) CD8+ T cells.

    Change from baseline in the percentage of CD8+ T cells expressing the γδ T-cell receptor (TCR) out of the total CD8+ T lymphocyte population, assessed by flow cytometry.

    Time frame: At weeks 0, 4, 12, 24, 36 and 48.

  9. Transcriptomic profiles in different lymphocyte subsets.

    Analysis of transcriptomic characteristics in different lymphocyte subsets by Next-Generation Sequencing (NGS).

    Time frame: At weeks 0, 4, 12, 24, 36 and 48

  10. Serum levels of immunosenescence markers.

    Change from baseline of serum immunosenescence-related markers, including Interleukin-8 (IL-8), Monocyte Chemoattractant Protein-1 (MCP-1), C-C Motif Chemokine Ligand 5 (CCL5), and C-X-C Motif Chemokine Ligand 1 (CXCL1), assessed by laboratory analysis. Units: Picograms per milliliter (pg/mL).

    Time frame: At weeks 0, 4, 12, 24, 36 and 48.

  11. Serum levels of IL-6 and TNF-alpha.

    Change from baseline of serum inflammatory and immune activation markers, including Interleukin-6 (IL-6) and Tumor Necrosis Factor-alpha (TNF-alpha), assessed by laboratory analysis. Units: Picograms per milliliter (pg/mL)

    Time frame: At weeks 0, 4, 12, 24, 36 and 48.

  12. Serum levels of soluble CD14 and soluble CD163.

    Change from baseline of serum inflammatory and immune activation markers, including soluble CD14 (sCD14) and soluble CD163 (sCD163), assessed by laboratory analysis. Units: Nanograms per milliliter (ng/mL).

    Time frame: At weeks 0, 4, 12, 24, 36 and 48.

  13. Serum levels of C-Reactive Protein (CRP).

    Change from baseline of C-Reactive Protein (CRP) in serum samples, assessed by laboratory analysis. Units: Milligrams per deciliter (mg/dL).

    Time frame: At weeks 0, 4, 12, 24, 36 and 48.

  14. Change from baseline of autologous neutralizing antibodies.

    Measurement of autologous neutralizing antibody levels to evaluate changes from baseline.

    Time frame: At weeks 4, 8, 12, 24, 36 and 48

  15. Predictive model for post-treatment viral control.

    Probability score generated by the statistical integration of clinical, genetic, immunologic, and virologic parameters to predict post-treatment control. The final mathematical model will yield an estimated probability of maintaining viral control, where 100% indicates the maximum probability of control. Units: Percentage (%).

    Time frame: From the start of Analytical Treatment Interruption (ATI) up to 24 weeks.

  16. Characterization of the cytotoxic activity of CD4, CD8 and cellular proliferation after stimulation with HIV peptides as compared to basal levels.

    Time frame: At weeks 4, 12, 24, 36 and 48

  17. Cytotoxic activity of NK cells as assessed by anti-HIV peptide responses, granzyme production and killing of K562 and Raji cells.

    Time frame: At weeks 0, 4, 12, 24, 36 and 48.

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Jan 2027, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2026
First posted
Oct 15, 2026
StartEst.
Oct 2026
Primary completionEst.
Jan 2027
CompletionEst.
Dec 2027
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07875504
Lead sponsor
Fundacion Clinic per a la Recerca Biomédica
Responsible party
Sponsor
First posted
Oct 15, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 15, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion