Comparing two HIV treatment regimens in men with suppressed viral loads

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness and safety of a dual therapy regimen using Darunavir/Cobicistat plus Lamivudine compared to the standard therapy of Darunavir/Cobicistat plus Tenofovir/Emtricitabine in men who are virologically suppressed for at least six months. Participants will be randomly assigned to either continue their current treatment or switch to the new regimen, with follow-up assessments at 24 and 48 weeks to monitor viral load levels. The study aims to determine if the new regimen is non-inferior to the standard treatment in maintaining viral suppression.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men with HIV infection who are virologically suppressed with DRV/c (800 mg/150 mg) + TFV/FTC (300 mg/200 mg) for at least 6 months
* Age ≥18 years-70 years
* eGFR ≥30 mL/min
* Written informed consent
* Beneficiaries of the Mexican Social Security Institute treated at the Infectious Diseases Hospital of the La Raza National Medical Center.

Exclusion Criteria:

* Withdrawal of informed consent
* Loss of medical insurance
* Presence of tuberculosis or other opportunistic infection requiring adjustment of the ARV regimen
* Incomplete data collected during visits Uncontrolled chronic gastrointestinal conditions Desire to be on a single-dose regimen Coinfection with hepatitis B virus during follow-up if in the DRV/3TC arm Coinfection with hepatitis C virus during follow-up

Where it's running

• Hospital de Infectología, Centro Médico Nacional La Raza
  Mexico City, Mexico City, Mexico Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.