Dual therapy based on co-formulated darunavir/ritonavir plus lamivudine for initial therapy of HIV infection: The ANDES randomized controlled trial.
M I Figueroa, O Sued, D Cecchini...
https://pubmed.ncbi.nlm.nih.gov/39151647Actively Recruiting
Phase 4
Age: 18Years - 70Years
MALE
ID06907056
Effectiveness, Safety, and Tolerability of Darunavir/Cobicistat Plus Lamivudine Versus Darunavir/Cobicistat Plus Tenofovir/Emtricitabine in Virologically Suppressed HIV-1-positive Men: 48-week Follow-up in Mexico
Led by José Antonio Mata Marín · Updated on 2025-04-04
138
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the effectiveness, safety, and tolerability of two antiretroviral therapies in men living with HIV who have had undetectable HIV-1 RNA levels for at least 6 months. Specifically, the study compares the standard three-drug therapy using darunavir/cobicistat plus tenofovir/emtricitabine with an experimental dual therapy of darunavir/cobicistat plus lamivudine. The trial is open-label, randomized, and focuses on whether the dual therapy is not less effective than standard therapy over 48 weeks. Participants are randomly assigned to either continue the standard treatment of darunavir/cobicistat (800 mg/150 mg) plus tenofovir/emtricitabine (300 mg/200 mg) once daily or switch to the dual therapy of darunavir/cobicistat (800 mg/150 mg) plus lamivudine (300 mg) once daily. The study includes an initial analysis at 24 weeks and continued follow-up at 48 weeks. Various laboratory tests, body composition measurements, and questionnaires assessing mental health and treatment satisfaction are conducted throughout the study. During participation, men will have regular medical visits with laboratory assessments including blood counts, liver function, kidney function, lipid profiles, and viral load measurements before randomization and at 3, 6, and 12 months afterward. Questionnaires evaluating anxiety, depression, sleep quality, and treatment satisfaction are also administered. Researchers will monitor adverse effects and classify them according to severity. The primary outcome is the proportion of participants maintaining viral suppression, measured at 48 weeks, with safety and tolerability also evaluated.
CONDITIONS
Brief Title
Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Versus Darunavir/Cobicistat Plus Tenofovir/Emtricitabine in Virologically Suppressed HIV-1-positive Individuals in Mexico
Who Can Participate
Age: 18Years - 70Years
MALE
Eligibility Criteria
You may qualify if you...
- 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 65 18 years and 85 70 years
- eGFR 65 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 48 weeks
Participants receive either dual therapy with darunavir/cobicistat plus lamivudine or standard therapy with darunavir/cobicistat plus tenofovir/emtricitabine for HIV-1 suppression.
Visits at 4, 12, 24, and 48 weeks post-randomization
Follow-up
Duration - Up to 48 weeks total including treatment
Participants are monitored for effectiveness, safety, and tolerability after completing the treatment period.
Visits at 3 months, 6 months, and 12 months post-study entry for CD4+ and HIV-1 RNA assessments
Trial Site Locations
Total: 1 location
1
Hospital de Infectología, Centro Médico Nacional La Raza
Mexico City, Mexico City, Mexico, 02990
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Federico Pulido, Esteban Ribera, María Lagarde...
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José A Perez-Molina, Rafael Rubio, Antonio Rivero...
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Pedro Cahn, Jaime Andrade-Villanueva, José R Arribas...
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Amit C Achhra, Gwamaka Mwasakifwa, Janaki Amin...
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Katya C Corado, Margaret R Caplan, Eric S Daar
https://pubmed.ncbi.nlm.nih.gov/30464404Immunological and inflammatory changes after simplifying to dual therapy in virologically suppressed HIV-infected patients through week 96 in a randomized trial.
María Trujillo-Rodríguez, Esperanza Muñoz-Muela, Ana Serna-Gallego...
https://pubmed.ncbi.nlm.nih.gov/35289296