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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Mexico
Hospital de Infectología, Centro Médico Nacional La Raza
RECRUITING
Mexico City
Time Frame
Start Date: 2023-11-09
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 138
Treatments
Active_comparator: Standar therapy
Darunavir/cobicistat 800/150 mg + tenofovir/emtricitabin 300/200 mg This arm is the commonly used therapy or standard 3-drug therapy consisting of Darunavir/cobicistad 800/150 mg, plus tenofovir/emtricitabine 300/200 mg
Experimental: Dual therapy
Darunavir/cobicistat 800/150 mg + lamivudine 300 mg This arm is the experimental one, with dual therapy, 2 drugs: darunavir/cobicistat 800/150 mg plus lamivudine 300 mg
Related Therapeutic Areas
Sponsors
Leads: José Antonio Mata Marín

This content was sourced from clinicaltrials.gov

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