NCT05699785Active, not recruiting
Comparison of Inflammatory Markers and Incidence of Comorbidities in Patients on Antiretroviral Therapy With Second-generation Anti-integrase Drugs on Triple Versus Dual Therapy
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
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 27 Dec 2022
- Start date
- 16 Feb 2023
- Primary completion date
- 16 Feb 2028
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Diseases
- HIV
- NCT number
- NCT05699785
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 16 Feb 2023 to the primary completion date, 16 Feb 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Non-daily or intermittent antiretroviral therapy regimen (e.g., 4 or 5 days a week)
Other illness
- Opportunistic infections during curative treatment
- HIV-2 infection
- Active hepatitis C
Other
- 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
- Refusal to participate
- Withdrawal of informed consent by the patient
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CH Simone VEIL Coordinator of this site? Confirm its status | Cannes | France | Unknown status |
| CHU Nice Coordinator of this site? Confirm its status | Nice | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.