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Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Versus Darunavir/Cobicistat Plus Tenofovir/Emtricitabine in Virologically Suppressed HIV-1-positive Individuals in Mexico

NCT06907056 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

  • HIV Infection

Interventions

DRUG

dual therapy

Intervention arm will be dual therapy oh DRV/C 800/150 mg + 3TC 300 mg, this will be compared to standar therapy of 3 drugs with: DRV/c 800/150 mg + TDF/FTC 300/200 mg

DRUG

Standard Medical Therapy

DRV/c+TDF/FTC

Sponsors & Collaborators

  • José Antonio Mata Marín

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-09
Primary Completion
2026-02-28
Completion
2026-11-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06907056 on ClinicalTrials.gov