Tests a two-drug HIV regimen with lamivudine in virus-suppressed adults
Compares switching to lamivudine versus keeping current HIV drugs in adults.
Plain-language title generated from the registry record
Registry title: Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Versus Darunavir/Cobicistat Plus Tenofovir/Emtricitabine in Virologically Suppressed HIV-1-positive Individuals in Mexico
Key facts
- Where
- Mexico City, MexicoSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men living with HIV whose virus is under control on darunavir/cobicistat plus tenofovir/emtricitabine. It compares staying on that treatment with switching to darunavir/cobicistat plus lamivudine.
- Age
- 18 to 70 years
- Sex
- Men only
- Disease stage
- HIV infection with the virus suppressed (HIV-1 RNA below 50 copies/ml) for at least 6 months
- Earlier treatment
- Must have taken DRV/c (800 mg/150 mg) + TFV/FTC (300 mg/200 mg) for at least 6 months
- Biomarker or test result
- eGFR of 30 mL/min or higher
Main reasons for not taking part
- Tuberculosis or another opportunistic infection that needs a change of the HIV treatment
- Uncontrolled long-term stomach or bowel conditions
- Wish to be on a single-pill regimen
- Hepatitis B coinfection during follow-up (in the DRV/3TC arm)
- Hepatitis C coinfection during follow-up
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06907056, who can take part
Where in Mexico
- Hospital de infectología, Centro Médico Nacional La RazaMexico City, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- José Antonio Mata Marín
- Trial code
- NCT06907056
- Record updated
- 4 April 2025
- Original 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 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.Read full original descriptionShow less
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
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.
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: 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; Withdrawal of informed consent; Loss of medical insurance.