HIVCLINIC-CURENCT07875504
A Clinical Trial of Analytical Treatment Interruption in People With HIV With a Highly Favourable Profile
A study testing Treatment interruption in people with HIV, run by Fundacion Clinic per a la Recerca Biomédica.
Trial summary
A pilot single exploratory clinical trial of ATI in a selected sample of PWH sharing specific genetic, phenotypic and clinical characteristics. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV
- What is being tested?
- Treatment interruption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 informed consent to participate.
- Having a favourable genotype AND a favourable NK phenotype defined by
- the presence of HLAB35 +, Bw4 > 1 + 2 threonine or HLA Bw4 > 2 + 2 threonine AND
- the presence of a percentage > 16% in NK memory-like cells displaying CD57+, NKG2C, KIR3DL1 and KIR2DL3 markers.
- On active ART for a minimum of 2 years.
- Undetectable VL at the moment of inclusion and ATI.
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- CD4 counts ≥500 at the moment of ATI.
- CD4 T cell count nadir ≥ 200 (for people who was diagnosed in primary infection) and ≥ 350 (for chronic infections).
- Participant agrees to follow HIV preventive practices.
- Women of child-bearing potential* must have a negative pregnancy test in serum or urine before the inclusion in the study.
Who cannot join
- Pregnant or breastfeeding.
- Active HBV or HCV co-infection (defined by positive HBs Antigen and positive HCV-RNA)
- Past or current evidence of severe opportunistic infection such as CMV retinitis or cryptococcalmeningitis.
- Active or substantial cardiovascular, kidney or liver disease.
- Current cancer of any type or any history of HIV-related cancer.
- Active or latent tuberculosis infection.
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- Any significant co-morbidity at discretion of the investigator that may be jeopardized in case of incomplete HIV viral suppression.
- Current or previous use of Long-acting injectable ART.
- History of antiretroviral drug resistance and no other options beyond their current regimen.
- Receipt of broadly neutralising antibodies within the past 2 years.
- 2 or more VL determinations > 50 copies/ml in the 2 years previous to ATI.
- Any concomitant immunosuppressive medication.
- Men or women of childbearing potential unable or unwilling to use highly efficient contraceptive measures** from the beginning until the end of the study.
About this study
Official title: CLINIC-CURE, a Pilot Exploratory Clinical Trial of Analytical Treatment Interruption in People With HIV With a Highly Favourable Profile
A pilot single exploratory clinical trial of ATI in a selected sample of PWH sharing specific genetic, phenotypic and clinical characteristics.
- Conditions
- HIV
- Being tested
- Treatment interruption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment interruptionOther
Antiretroviral treatment interruption in people with HIV with a highly favorable profile
| Study group | Role | What they receive |
|---|---|---|
| Treatment interruption | Experimental | Antiretroviral treatment interruption in people with HIV with a highly favorable profile Receives: Other: Treatment interruption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of individuals with VL<50 copies.
Measured: At 24 weeks of ATI
Secondary outcomes (17)
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
Measured: At 24 weeks post-ATI
To determine time to rebound after ATI.
Time (in weeks) to viral rebound (VL≥ 50).
Measured: From the start of Analytical Treatment Interruption (ATI) up to 24 weeks.
Proportion of participants with clinical symptoms during Analytical Treatment Interruption (ATI).
Percentage of participants experiencing any clinical symptom or retroviral syndrome during ATI.
Measured: From the start of Analytical Treatment Interruption (ATI) up to 24 weeks.
To study the HIV reservoir.
Evolution of the viral reservoir as measured by IPDA and intracellular viral RNA.
Measured: At weeks 0, 4, 12, 24, 36 and 48.
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.
Measured: At weeks 0, 4, 12, 24., 36 and 48.
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.
Measured: At weeks 0, 4, 12,24, 36 and 48.
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.
Measured: At weeks 0, 4, 12, 24, 36 and 48.
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.
Measured: At weeks 0, 4, 12, 24, 36 and 48.
Transcriptomic profiles in different lymphocyte subsets.
Analysis of transcriptomic characteristics in different lymphocyte subsets by Next-Generation Sequencing (NGS).
Measured: At weeks 0, 4, 12, 24, 36 and 48
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).
Measured: At weeks 0, 4, 12, 24, 36 and 48.
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)
Measured: At weeks 0, 4, 12, 24, 36 and 48.
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).
Measured: At weeks 0, 4, 12, 24, 36 and 48.
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).
Measured: At weeks 0, 4, 12, 24, 36 and 48.
Change from baseline of autologous neutralizing antibodies.
Measurement of autologous neutralizing antibody levels to evaluate changes from baseline.
Measured: At weeks 4, 8, 12, 24, 36 and 48
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 (%).
Measured: From the start of Analytical Treatment Interruption (ATI) up to 24 weeks.
Characterization of the cytotoxic activity of CD4, CD8 and cellular proliferation after stimulation with HIV peptides as compared to basal levels.
Measured: At weeks 4, 12, 24, 36 and 48
Cytotoxic activity of NK cells as assessed by anti-HIV peptide responses, granzyme production and killing of K562 and Raji cells.
Measured: At weeks 0, 4, 12, 24, 36 and 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875504
- Sponsor's protocol ID
- CLINIC-CURE
- Other IDs
- 2026-526395-23-00
- Acronym
- CLINIC-CURE
- Status last verified
- Aug 2026
- First submitted
- 21 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINIC-CURE, a Pilot Exploratory Clinical Trial of Analytical Treatment Interruption in People With HIV With a Highly Favourable Profile
- ClinicalTrials.gov ID
- NCT07875504
- Acronym / sponsor ID
- CLINIC-CURE / CLINIC-CURE
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot single exploratory clinical trial of ATI in a selected sample of PWH sharing specific genetic, phenotypic and clinical characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment interruption | Experimental | Other: Treatment interruptionAntiretroviral treatment interruption in people with HIV with a highly favorable profile |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 informed consent to participate.
- Having a favourable genotype AND a favourable NK phenotype defined by
- On active ART for a minimum of 2 years.
- Undetectable VL at the moment of inclusion and ATI.
- CD4 counts ≥500 at the moment of ATI.
Key exclusion criteria (13 listed)
- Pregnant or breastfeeding.
- Active HBV or HCV co-infection (defined by positive HBs Antigen and positive HCV-RNA)
- Past or current evidence of severe opportunistic infection such as CMV retinitis or cryptococcalmeningitis.
- Active or substantial cardiovascular, kidney or liver disease.
- Current cancer of any type or any history of HIV-related cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment interruptionAntiretroviral treatment interruption in people with HIV with a highly favorable profile | Other | Treatment interruption |
Primary outcome
Proportion of individuals with VL<50 copies.
Time frame: At 24 weeks of ATI
17 secondary outcomes
To determine the proportion of patients with partial viral control up to 24 weeks (< 200, < 400 and <1000 copies/ml) of ATI.
Time frame: At 24 weeks post-ATI
To determine time to rebound after ATI.
Time frame: From the start of Analytical Treatment Interruption (ATI) up to 24 weeks.
Proportion of participants with clinical symptoms during Analytical Treatment Interruption (ATI).
Time frame: From the start of Analytical Treatment Interruption (ATI) up to 24 weeks.
To study the HIV reservoir.
Time frame: At weeks 0, 4, 12, 24, 36 and 48.
To study viral inhibition in CD4 counts.
Time frame: At weeks 0, 4, 12, 24., 36 and 48.
Percentage of senescent CD8+ T lymphocytes
Time frame: At weeks 0, 4, 12,24, 36 and 48.
Percentage of memory-like Natural Killer (NK) cells.
Time frame: At weeks 0, 4, 12, 24, 36 and 48.
Percentage of gamma-delta (γδ) CD8+ T cells.
Time frame: At weeks 0, 4, 12, 24, 36 and 48.
Transcriptomic profiles in different lymphocyte subsets.
Time frame: At weeks 0, 4, 12, 24, 36 and 48
Serum levels of immunosenescence markers.
Time frame: At weeks 0, 4, 12, 24, 36 and 48.
Serum levels of IL-6 and TNF-alpha.
Time frame: At weeks 0, 4, 12, 24, 36 and 48.
Serum levels of soluble CD14 and soluble CD163.
Time frame: At weeks 0, 4, 12, 24, 36 and 48.
Serum levels of C-Reactive Protein (CRP).
Time frame: At weeks 0, 4, 12, 24, 36 and 48.
Change from baseline of autologous neutralizing antibodies.
Time frame: At weeks 4, 8, 12, 24, 36 and 48
Predictive model for post-treatment viral control.
Time frame: From the start of Analytical Treatment Interruption (ATI) up to 24 weeks.
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment interruption in people with HIV, run by Fundacion Clinic per a la Recerca Biomédica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of individuals with VL<50 copies. (time frame: At 24 weeks of ATI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.