Status:
RECRUITING
Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Versus Darunavir/Cobicistat Plus Tenofovir/Emtricitabine in Virologically Suppressed HIV-1-positive Individuals in Mexico
Lead Sponsor:
José Antonio Mata Marín
Conditions:
HIV Infection
Eligibility:
MALE
18-70 years
Phase:
PHASE4
Brief Summary
Unicenter, open-label, randomized, noninferiority trial included men with HIV-1 RNA levels \<50 copies/ml for at least 6 months on antiretroviral therapy with DRV/c + TFV/FTC (standar therapy), aged o...
Detailed Description
Unicenter, open-label, randomized, noninferiority trial included men with HIV-1 RNA levels \<50 copies/ml for at least 6 months on antiretroviral therapy with DRV/c + TFV/FTC (standar therapy), aged o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT06907056
Start Date
November 9 2023
End Date
November 30 2026
Last Update
April 4 2025
Active Locations (1)
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1
Hospital de Infectología, Centro Médico Nacional La Raza
Mexico City, Mexico City, Mexico, 02990