AzTrials
AzTrials

HivCOLLATERAL 2NCT05699785

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

A study testing plasma inflammatory markers and CD4/CD8 ratio in people with Hiv, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hiv
What is being tested?
plasma inflammatory markers and CD4/CD8 ratio
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
2 sitesFrance
Study dates
16 Feb 2023to 16 Feb 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • Daily use of antiretroviral therapy
  • Effective contraception for women of childbearing potential will be requested
  • Signed informed consent
  • Enrollment in a Social Security plan

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CH Simone VEIL

    Cannes, 06614

  • CHU Nice

    Nice

Other trials in France

About this study

Official 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

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

Conditions
Hiv
Being tested
plasma inflammatory markers, CD4/CD8 ratio
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • plasma inflammatory markersOther

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

  • CD4/CD8 ratioOther

    Evolution of CD4/CD8 ratio

Study groups in NCT05699785
Study groupRoleWhat they receive
patients on antiretroviral therapy with second generation anti-integrase drugs in triple therapyExperimentalNot described
Receives: Other: plasma inflammatory markers; Other: CD4/CD8 ratio
patients on antiretroviral therapy with second generation anti-integrase drugs in dual therapyExperimentalNot described
Receives: Other: plasma inflammatory markers; Other: CD4/CD8 ratio

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma inflammatory markers

    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.

    Measured: 3 years after baseline

  2. CD4/CD8 ratio

    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

    Measured: 3 years after baseline

Secondary outcomes (24)

  1. Virological failure rate (year 1)

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

    Measured: One year after baseline

  2. residual viremia rate (year 1)

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

    Measured: One year after baseline

  3. Virological failure rate (year 2)

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

    Measured: two years after baseline

  4. Residual viremia rate (year 2)

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

    Measured: two years after baseline

  5. Virological failure rate (year 3)

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

    Measured: three years after baseline

  6. Residuak viremia rate (year 3)

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

    Measured: 3 years after baseline

  7. Prevalence of neuropsychiatric events at 1 year

    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.

    Measured: 1 year after baseline

  8. Prevalence of neuropsychiatric events at 2 years

    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.

    Measured: 2 years after baseline

  9. Prevalence of neuropsychiatric events at 3 years

    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.

    Measured: 3 years after baseline

  10. changes in antiretroviral therapy (year 1)

    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

    Measured: 1 year after baseline

  11. changes in antiretroviral therapy (year 2)

    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

    Measured: 2 years after baseline

  12. changes in antiretroviral therapy (year 3)

    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

    Measured: 3 years after baseline

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

    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)

    Measured: 1 year after baseline

  14. plasma markers assay (year 1)

    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)

    Measured: 1 year after baseline

  15. plasma markers assay (year 2)

    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)

    Measured: 2 years after baseline

  16. plasma markers assay (year 3)

    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)

    Measured: 3 years after baseline

  17. risk factors for immune hyper activation

    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

    Measured: 3 years after baseline

  18. immune activation markers assays and identification of comorbidities

    Correlate immune activation markers with the occurrence of comorbidities

    Measured: 3 years after baseline

  19. comorbidities (year 1)

    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

    Measured: 1 year after baseline

  20. comorbidities (year 2)

    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

    Measured: 2 years after baseline

  21. comorbidities (year 3)

    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

    Measured: 3 years after baseline

  22. Onset of new comorbidity

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

    Measured: 3 years after baseline

  23. patient profiles

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

    Measured: 3 years after baseline

  24. individualized and computerized care plan

    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

    Measured: 3 years after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start16 Feb 2023
  3. Primary completion16 Feb 2028 (estimated)
  4. Study completion16 Feb 2028 (estimated)

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05699785
Sponsor's protocol ID
22-PP-04
Acronym
COLLATERAL 2
Status last verified
Jun 2026
First submitted
27 Dec 2022
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing plasma inflammatory markers and CD4/CD8 ratio in people with Hiv, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.

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 8 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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Plasma inflammatory markers (time frame: 3 years after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05699785.

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 22 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in