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NCT Number: NCT05699785

Comparison of Inflammatory Markers and Incidence of Comorbidities in Patients on Antiretroviral Therapy With Second-generation Anti-integrase Drugs on Triple Versus Dual Therapy

HIV-infected patients develop comorbidities earlier than the general population. Immune activation with the secretion of pro-inflammatory cytokines would play a major role in the occurrence of these comorbidities. Numerous factors, called risk factors, already identified in the general population and confirmed in patients with HIV virus favor the occurrence of these comorbidities but cannot alone explain the overrepresentation and precocity of these comorbidities in the HIV population. Investigators hypothesize that optimization or simplification with certain classes of antiretrovirals modify the inflammatory response and are predictive factors for the occurrence of comorbidities

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Simone VEIL, Cannes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-1 infection
  • Age > 40 years or adults with more than 10 years of antiretroviral therapy
  • Switching to BIC/FTC/TAF or DTG/3TC or DTG+3TC within the last 2 years
  • Plasma HIV-1 RNA viral load < 50 copies/ml for more than 6 months
  • Absence of chronic hepatitis B infection
  • Absence of genotype mutations on Dolutegravir (DTG) or Bictegravir (BIC) or tenofovir alafenamide TAF
  • Daily use of antiretroviral therapy
  • Effective contraception for women of childbearing potential will be requested
  • Signed informed consent
  • Enrollment in a Social Security plan

Exclusion criteria

  • Non-daily or intermittent antiretroviral therapy regimen (e.g., 4 or 5 days a week)
  • Pregnancy or breastfeeding
  • Vulnerable persons according to article L.1121-6 of the public health code Persons unable to give consent according to article L.1121-8 of the public health code
  • Opportunistic infections during curative treatment
  • HIV-2 infection
  • Active hepatitis C
  • Refusal to participate
  • Withdrawal of informed consent by the patient

Treatment and study plan

plasma inflammatory markers

Other

Evolution of different plasma inflammatory markers (CRP, IL6, D-Dimers, CD14s, CD163, IL-1, IP-10, MCP-1, IL-18, IFAB)

CD4/CD8 ratio

Other

Evolution of CD4/CD8 ratio

Primary outcomes

  1. Plasma inflammatory markers

    Time frame: 3 years after baseline

    To measure the evolution of different plasma inflammatory markers (CRP, IL6, D-Dimers, CD14s, CD163, IL-1, IP-10, MCP-1, IL-18, IFAB) over 3 years between the 2 groups.

  2. CD4/CD8 ratio

    Time frame: 3 years after baseline

    To measure the evolution of CD4/CD8 ratio over 3 years between the 2 groups. A CD4/CD8 ratio is considered normal if it is greater than 0.75. Immune hyperactivation occurs when the ratio is below 0.75

Secondary outcomes

  1. Virological failure rate (year 1)

    Time frame: One year after baseline

    Virological failure rate (plasma HIV-1 RNA viral load > 50 copies/ml on two consecutive measurements)

  2. residual viremia rate (year 1)

    Time frame: One year after baseline

    Evolution of the residual viremia rate (detected or quantifiable plasma HIV-1 RNA viral load < 50 copies/ml)

  3. Virological failure rate (year 2)

    Time frame: two years after baseline

    Virological failure rate (plasma HIV-1 RNA viral load > 50 copies/ml on two consecutive measurements)

  4. Residual viremia rate (year 2)

    Time frame: two years after baseline

    Evolution of the residual viremia rate (detected or quantifiable plasma HIV-1 RNA viral load < 50 copies/ml)

  5. Virological failure rate (year 3)

    Time frame: three years after baseline

    Virological failure rate (plasma HIV-1 RNA viral load > 50 copies/ml on two consecutive measurements)

  6. Residuak viremia rate (year 3)

    Time frame: 3 years after baseline

    Evolution of the residual viremia rate (detected or quantifiable plasma HIV-1 RNA viral load < 50 copies/ml)

  7. Prevalence of neuropsychiatric events at 1 year

    Time frame: 1 year after baseline

    To analyze the evolution at 1 year of the prevalence of neuropsychiatric events (including sleep disorders, anxiety, depression) between the two groups from the questionnaires.

  8. Prevalence of neuropsychiatric events at 2 years

    Time frame: 2 years after baseline

    To analyze the evolution at 2 years of the prevalence of neuropsychiatric events (including sleep disorders, anxiety, depression) between the two groups from the questionnaires.

  9. Prevalence of neuropsychiatric events at 3 years

    Time frame: 3 years after baseline

    To analyze the evolution at 2 years of the prevalence of neuropsychiatric events (including sleep disorders, anxiety, depression) between the two groups from the questionnaires.

  10. changes in antiretroviral therapy (year 1)

    Time frame: 1 year after baseline

    Analyze the 1-year change in the prevalence of changes in antiretroviral therapy and the reasons for changes between the two groups based on questionnaires

  11. changes in antiretroviral therapy (year 2)

    Time frame: 2 years after baseline

    Analyze the 2-years change in the prevalence of changes in antiretroviral therapy and the reasons for changes between the two groups based on questionnaires

  12. changes in antiretroviral therapy (year 3)

    Time frame: 3 years after baseline

    Analyze the 3-years change in the prevalence of changes in antiretroviral therapy and the reasons for changes between the two groups based on questionnaires

  13. Evolution of intracellular markers (CD8/CD38, HLA-DR) (year 1)

    Time frame: 1 year after baseline

    To analyze the evolution of intracellular markers (CD8/CD38, HLA-DR) at 1 year between the two cohorts in high-risk subjects (nadir CD4<200 cells/mm3 or history of AIDS stage, or subject aged ≥ 65 years)

  14. plasma markers assay (year 1)

    Time frame: 1 year after baseline

    Analyze the evolution of plasma markers at 1 year between the two cohorts in high-risk subjects (nadir CD4<200 cells/mm3 or history of AIDS stage, or subject aged ≥ 65 years)

  15. plasma markers assay (year 2)

    Time frame: 2 years after baseline

    Analyze the evolution of plasma markers at 2 years between the two cohorts in high-risk subjects (nadir CD4<200 cells/mm3 or history of AIDS stage, or subject aged ≥ 65 years)

  16. plasma markers assay (year 3)

    Time frame: 3 years after baseline

    Analyze the evolution of plasma markers at 3 years between the two cohorts in high-risk subjects (nadir CD4<200 cells/mm3 or history of AIDS stage, or subject aged ≥ 65 years)

  17. risk factors for immune hyper activation

    Time frame: 3 years after baseline

    Analyze and compare risk factors for immune hyper activation (age, CD4 nadir<200 cells/mm3, AIDS stage, residual viremia, archived M184V/I resistance...) in each group

  18. immune activation markers assays and identification of comorbidities

    Time frame: 3 years after baseline

    Correlate immune activation markers with the occurrence of comorbidities

  19. comorbidities (year 1)

    Time frame: 1 year after baseline

    Measurement of the true incidence of major 11 comorbidities (Depression, Cardiovascular, Osteoporosis, Non-AIDS related cancers, Metabolic syndrome, Cognitive disorders, Chronic renal failure , proximal renal tubulopathy, Hepatic fibrosis, Chronic Obstructive Pulmonary Disease, Osteoarthritis) at 1 year

  20. comorbidities (year 2)

    Time frame: 2 years after baseline

    Measurement of the true incidence of major 11 comorbidities (Depression, Cardiovascular, Osteoporosis, Non-AIDS related cancers, Metabolic syndrome, Cognitive disorders, Chronic renal failure , proximal renal tubulopathy, Hepatic fibrosis, Chronic Obstructive Pulmonary Disease, Osteoarthritis) at 2 years

  21. comorbidities (year 3)

    Time frame: 3 years after baseline

    Measurement of the true incidence of major 11 comorbidities (Depression, Cardiovascular, Osteoporosis, Non-AIDS related cancers, Metabolic syndrome, Cognitive disorders, Chronic renal failure , proximal renal tubulopathy, Hepatic fibrosis, Chronic Obstructive Pulmonary Disease, Osteoarthritis) at 3 years

  22. Onset of new comorbidity

    Time frame: 3 years after baseline

    Measure the time to onset of new comorbidity(ies) in each group.

  23. patient profiles

    Time frame: 3 years after baseline

    Describe patient profiles at risk for comorbidities based on different inflammatory biomarkers

  24. individualized and computerized care plan

    Time frame: 3 years after baseline

    Establish an individualized and computerized care plan for the patient after evaluation of the risk factors (according to the profiles) to detect the occurrence or aggravation of comorbidities

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Comparison of Inflammatory Markers and Incidence of Comorbidities in Patients on Antiretroviral Therapy (ART) With Second-generation Anti-integrase Drugs on Triple Versus Dual Therapy

Acronym: COLLATERAL 2

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 26, 2023
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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