Comparison of Inflammatory Markers and Incidence of Comorbidities in Patients on Antiretroviral Therapy With Second-generation Anti-integrase Drugs on Triple Versus Dual Therapy (COLLATERAL 2)

June 18, 2026 updated by: Centre Hospitalier Universitaire de Nice

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Cannes, France, 06614
        • CH Simone VEIL
      • Nice, France
        • CHU NICE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: patients on antiretroviral therapy with second generation anti-integrase drugs in triple therapy
Other: plasma inflammatory markers
Evolution of different plasma inflammatory markers (CRP, IL6, D-Dimers, CD14s, CD163, IL-1, IP-10, MCP-1, IL-18, IFAB)
Other: CD4/CD8 ratio
Evolution of CD4/CD8 ratio
Experimental: patients on antiretroviral therapy with second generation anti-integrase drugs in dual therapy
Other: plasma inflammatory markers
Evolution of different plasma inflammatory markers (CRP, IL6, D-Dimers, CD14s, CD163, IL-1, IP-10, MCP-1, IL-18, IFAB)
Other: CD4/CD8 ratio
Evolution of CD4/CD8 ratio

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 years after baseline
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
3 years after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
One year after baseline
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)
One year after baseline
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)
two years after baseline
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)
two years after baseline
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)
three years after baseline
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)
3 years after baseline
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.
1 year after baseline
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.
2 years after baseline
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.
3 years after baseline
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
1 year after baseline
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
2 years after baseline
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
3 years after baseline
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)
1 year after baseline
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)
1 year after baseline
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)
2 years after baseline
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)
3 years after baseline
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
3 years after baseline
immune activation markers assays and identification of comorbidities
Time Frame: 3 years after baseline
Correlate immune activation markers with the occurrence of comorbidities
3 years after baseline
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
1 year after baseline
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
2 years after baseline
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
3 years after baseline
Onset of new comorbidity
Time Frame: 3 years after baseline
Measure the time to onset of new comorbidity(ies) in each group.
3 years after baseline
patient profiles
Time Frame: 3 years after baseline
Describe patient profiles at risk for comorbidities based on different inflammatory biomarkers
3 years after baseline
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
3 years after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nice

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jacques Durant, durant.j@chu-nice.fr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 16, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 16, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22-PP-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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