Comparing inflammatory markers in HIV patients on different antiretroviral therapies
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
This study tests whether changing HIV medications can lower inflammation and help prevent other health issues in patients over 40 or those who have been on treatment for more than ten years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 2 sites (Cannes and 1 other locations) |
| Trial ID | NCT05699785 on ClinicalTrials.gov |
What this trial studies
This study investigates the inflammatory markers and incidence of comorbidities in HIV-infected patients undergoing antiretroviral therapy with second-generation anti-integrase drugs. It aims to determine whether switching to specific combinations of medications can modify the inflammatory response and predict the occurrence of comorbidities. The study focuses on patients over 40 years old or those who have been on therapy for over a decade, assessing their health outcomes based on their treatment regimen.
Who should consider this trial
Good fit: Ideal candidates are HIV-1 infected individuals over 40 years old or those with more than 10 years on antiretroviral therapy who have maintained a low viral load.
Not a fit: Patients who are not on a daily antiretroviral regimen or those with active infections or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of comorbidities in HIV patients, enhancing their overall health and quality of life.
How similar studies have performed: While there is ongoing research in this area, the specific approach of comparing inflammatory markers in the context of second-generation anti-integrase drugs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cannes and 1 other locations
- CH Simone VEIL — Cannes, France (Recruiting)
- CHU Nice — Nice, France (Recruiting)
Study contacts
- Principal investigator: Jacques Durant — durant.j@chu-nice.fr
- Study coordinator: Jacques Durant
- Email: durant.j@chu-nice.fr
- Phone: 04.92.03.97.11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.