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Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Compared With Darunavir/Cobicistat Plus Tenofovir Alafenamide/Emtricitabine in Virologically Suppressed People Living With HIV at 24 and 48 Weeks of Follow-up

NCT07678268 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-07-01

No results posted yet for this study

Summary

A single-center, open-label, randomized pilot clinical trial between March 2025 and March 2026 at the Hospital de Infectología "La Raza" National Medical Center in Mexico City. Eligible participants were adult males (≥18 years) with HIV-1 infection who had maintained virological suppression (HIV-1 RNA \<50 copies/mL) for 48 weeks on either DRV/c + 3TC or DRV/c + TDF/FTC prior to enrollment (TLALOC-1 trial), and had an estimated glomerular filtration rate (eGFR) by CKD-EPI ≥60 mL/min/1.73 m². The primary endpoints were virological efficacy and safety at 24 weeks.

Conditions

Interventions

DRUG

Dual therapy: darunavir/cobicistat + lamivudine

The intervention group will receive dual therapy with DRV/C 800/150 mg + 3TC 300 mg, which will be compared to standard 3-drug therapy: DRV/C 800/150 mg + TAF/FTC 10/200 mg.

DRUG

Triple therapy: darunavir/cobicistat plus tenofovir alafenamide/emtricitabine

The intervention group will receive triple therapy: DRV/C 800/150 mg + TAF/FTC 10/200 mg.which will be compared to dual therapy with DRV/C 800/150 mg + 3TC 300 mg.

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    lead OTHER_GOV

Principal Investigators

  • Sandra Patricia Ramírez Eguia · Instituto Mexicano del Seguro Social

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-10
Primary Completion
2026-07-10
Completion
2026-12-10

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

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 NCT07678268 on ClinicalTrials.gov