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

CLINIC-CURE, a Pilot Exploratory Clinical Trial of Analytical Treatment Interruption in People With HIV With a Highly Favourable Profile

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07875504

Acronym

CLINIC-CURE

Enrollment

Registered

2026-10-15

Start date

2026-10-01

Completion date

2027-12-01

Last updated

2026-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Brief summary

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

Interventions

OTHERTreatment interruption

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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 informed consent 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. CD4 counts ≥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 HIV preventive practices. 8. Women of child-bearing potential\* must have a negative pregnancy test in serum or urine before the inclusion in the study.

Exclusion criteria

1. Pregnant or breastfeeding. 2. Active HBV or HCV 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 HIV-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 immunosuppressive medication. 13. Men or women of childbearing potential unable or unwilling to use highly efficient contraceptive measures\*\* from the beginning until the end of the study.

Design outcomes

Primary

Measure	Time frame
Proportion of individuals with VL<50 copies.	At 24 weeks of ATI

Secondary

Measure	Time frame	Description
To determine the proportion of patients with partial viral control up to 24 weeks (< 200, < 400 and <1000 copies/ml) of ATI.	At 24 weeks post-ATI	Proportion of participants with VL \< 200, \<400 copies/ml and VL \<1000 copies/ml
To determine time to rebound after ATI.	From the start of Analytical Treatment Interruption (ATI) up to 24 weeks.	Time (in weeks) to viral rebound (VL≥ 50).
Proportion of participants with clinical symptoms during Analytical Treatment Interruption (ATI).	From the start of Analytical Treatment Interruption (ATI) up to 24 weeks.	Percentage of participants experiencing any clinical symptom or retroviral syndrome during ATI.
To study the HIV reservoir.	At weeks 0, 4, 12, 24, 36 and 48.	Evolution of the viral reservoir as measured by IPDA and intracellular viral RNA.
To study viral inhibition in CD4 counts.	At weeks 0, 4, 12, 24., 36 and 48.	Viral inhibition "in vitro" (VIA assays) culturing CD4 lymphocytes in the presence of CD8 and/or NK lymphocytes.
Percentage of senescent CD8+ T lymphocytes	At weeks 0, 4, 12,24, 36 and 48.	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.
Percentage of memory-like Natural Killer (NK) cells.	At weeks 0, 4, 12, 24, 36 and 48.	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.
Percentage of gamma-delta (γδ) CD8+ T cells.	At weeks 0, 4, 12, 24, 36 and 48.	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.
Transcriptomic profiles in different lymphocyte subsets.	At weeks 0, 4, 12, 24, 36 and 48	Analysis of transcriptomic characteristics in different lymphocyte subsets by Next-Generation Sequencing (NGS).
Serum levels of immunosenescence markers.	At weeks 0, 4, 12, 24, 36 and 48.	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).
Serum levels of IL-6 and TNF-alpha.	At weeks 0, 4, 12, 24, 36 and 48.	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)
Serum levels of soluble CD14 and soluble CD163.	At weeks 0, 4, 12, 24, 36 and 48.	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).
Serum levels of C-Reactive Protein (CRP).	At weeks 0, 4, 12, 24, 36 and 48.	Change from baseline of C-Reactive Protein (CRP) in serum samples, assessed by laboratory analysis. Units: Milligrams per deciliter (mg/dL).
Change from baseline of autologous neutralizing antibodies.	At weeks 4, 8, 12, 24, 36 and 48	Measurement of autologous neutralizing antibody levels to evaluate changes from baseline.
Predictive model for post-treatment viral control.	From the start of Analytical Treatment Interruption (ATI) up to 24 weeks.	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 (%).
Characterization of the cytotoxic activity of CD4, CD8 and cellular proliferation after stimulation with HIV peptides as compared to basal levels.	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.	At weeks 0, 4, 12, 24, 36 and 48.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 16, 2026