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 | Recruiting Phase 4

• 1 other identifier: R-2025-3502-183
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

HIV Infection; Antiretroviral Therapy; Lentivirus Infections

Keywords

HIV infection; antiretroviral therapy; two drugs regimen; renal safety; neuropsychiatric adverse events

Outcome Measures

Primary Outcomes (1)

• Effectiveness

  HIV-1 RNA ≥50 copies/mL

  at 24 and 48 weeks

Secondary Outcomes (1)

• To determine the safety and tolerability 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

Study Arms (2)

Dual therapy: darunavir/cobicistat + lamivudine

ACTIVE COMPARATOR

Darunavir/cobicistat 800/150 mg + lamivudine 300 mg. This arm is the active comparator one, with dual therapy, 2 drugs: darunavir/cobicistat 800/150 mg plus lamivudine 300 mg

Drug: Dual therapy: darunavir/cobicistat + lamivudine

Triple therapy: darunavir/cobicistat plus tenofovir alafenamide/emtricitabine

EXPERIMENTAL

Darunavir/cobicistat 800/150 mg + tenofovir alafenamide/emtricitabine 10/200 mg. This treatment is the commonly used or standard 3-drug therapy, this arm is the active comparator one consisting of darunavir/cobicistat 800/150 mg, plus tenofovir alafenamide/emtricitabine 10/200 mg.

Drug: Triple therapy: darunavir/cobicistat plus tenofovir alafenamide/emtricitabine

Interventions

Dual therapy: darunavir/cobicistat + lamivudine DRUG

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.

Also known as: DRV/C+3TC

Dual therapy: darunavir/cobicistat + lamivudine

Triple therapy: darunavir/cobicistat plus tenofovir alafenamide/emtricitabine DRUG

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.

Also known as: DRV/c+TAF/FTC

Triple therapy: darunavir/cobicistat plus tenofovir alafenamide/emtricitabine

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: men who have sex with men (MSM)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Virologically suppressed men living with HIV, transitioning from a DRV/c (800 mg/150 mg) + TDF/FTC (300 mg/200 mg) regimen for at least 48 weeks prior to the study
• Viral suppression for 48 weeks prior to the study
• Agree to participate in the study by signing a written informed consent form
• Age ≥18 years
• Glomerular filtration rate (GFR) by CDK-EPI ≥60 mL/min
• Beneficiaries of the Mexican Social Security Institute (IMSS) treated at the Infectious Diseases Hospital of the "La Raza" National Medical Center

You may not qualify if:

• Withdrawal of informed consent
• Loss of coverage
• Failure to attend sample collection within the required timeframe

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Hospital de Infectología "Dr Daniel Méndez Hernández" National Medical Center "La Raza", Instituto Mexicano del Seguro Social

Mexico City, Mexico City, 02990, Mexico

RECRUITING

Related Publications (10)

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  PMID: 35079789 RESULT

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  PMID: 27629070 RESULT

• Van Vaerenbergh K. Study of the impact of HIV genotypic drug resistance testing on therapy efficacy. Verh K Acad Geneeskd Belg. 2001;63(5):447-73.

  PMID: 11813503 RESULT

• Gibas KM, Kelly SG, Arribas JR, Cahn P, Orkin C, Daar ES, Sax PE, Taiwo BO. Two-drug regimens for HIV treatment. Lancet HIV. 2022 Dec;9(12):e868-e883. doi: 10.1016/S2352-3018(22)00249-1. Epub 2022 Oct 26.

  PMID: 36309038 RESULT

• Hernandez-Jeronimo JH, Martinez-Rivera NC, Perez-Jimenez C, Volkow-Fernandez P, Martin-Onraet A. Multimorbidity in people living with HIV and cancer in Mexico. Gac Med Mex. 2024;160(2):144-153. doi: 10.24875/GMM.M24000888.

  PMID: 39116868 RESULT

• Medina-Gomez OS, Barrios-Perez A, Sosa-Tapia A, Diaz-Munoz I. [HIV mortality trends in Mexico, 2000-2022]. Rev Med Inst Mex Seguro Soc. 2024 Nov 4;62(6):1-7. doi: 10.5281/zenodo.13306693. Spanish.

  PMID: 39570084 RESULT

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  PMID: 35324881 RESULT

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  PMID: 11915000 RESULT

MeSH Terms

Conditions

HIV Infections; Lentivirus Infections

Interventions

Cobicistat; Lamivudine; emtricitabine tenofovir alafenamide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Sandra Patricia Ramírez Eguia

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Antonio Mata Marín, Master

CONTACT

+524428518215; sandrarmzeg@gmail.com

Jóse Antonio Mata Marin, Master

CONTACT

4428518215; sandrarmzeg@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This was a non-randomized study. Participants already receiving DRV/c + 3TC (1 tablet of DRV/c 800/150 mg and two tablets of 3TC of 150 mg each) continued on the same dual regimen. Participants receiving DRV/c + TDF/FTC switched the nucleoside backbone from TDF/FTC to TAF/FTC 10/200 mg while continuing DRV/c.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: Baseline results, as well as results at 24 and 48 weeks of follow-up, will be analyzed. Medians and interquartile ranges, or means and standard deviations, will be calculated depending on the data distribution, according to the Kolmogorov-Smirnov test. Percentages and proportions will be obtained for categorical variables. Depending on the data distribution, the Student's t-test for independent samples will be used to compare means between groups, or the Mann-Whitney U test will be used at baseline and at 48 weeks. To compare related variables at two different time points, paired t-tests will be used (in the case of a normal distribution) or the Wilcoxon signed-rank test (if the distribution was unconstrained). The association between categorical variables will be assessed using the chi-square test or Fisher's exact test, as appropriate. The independence of variables will be established using binary logistic regression for variables with statistical significance. A p-value ≤0.05.

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: July 10, 2025
• Primary Completion: July 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)