Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Versus Darunavir/Cobicistat Plus Tenofovir/Emtricitabine in Virologically Suppressed HIV-1-positive Individuals in Mexico (NCT06907056)
Effectiveness, Safety, and Tolerability of Darunavir/Cobicistat Plus Lamivudine Versus Darunavir/Cobicistat Plus Tenofovir/Emtricitabine in Virologically Suppressed HIV-1-positive Individuals: 48-week Follow-up in Mexico
🩺 Plain-English Summary (8th-Grade Level)
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 over 18 years. Participants were randomized to either continue standard therapy or switch to DRV/c+3TC. The primary end point was the proportion of subjects with HIV-1 RNA levels \>50 copies/ml after 48 weeks of follow-up according to the snapshot algorithm, with a non-inferiority margin of up to 10%. For statistical analysis, data distribution will be identified using the Kolmogorov-Smirnov test; categorical data will be analyzed using the X2 or Fisher test, as appropriate, and will be expressed as numbers and percentages. Quantitative data will be expressed as medians and interquartile ranges or means with standard deviations. A first analysis will be performed at 24 weeks, with follow-up at 48 weeks. The Student's t-test or the Mann-Whitney U-test will be used for data from independent groups according to their distribution.
Who can join: Review the eligibility criteria below.
Location: Hospital de Infectología, Centro Médico Nacional La Raza — Mexico City, Mexico City
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Hospital de Infectología, Centro Médico Nacional La Raza — Mexico City, Mexico City
📞 Contact the Study Coordinator
Phone: (229) 124-3665
Email: ana.knodiaz@gmail.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.