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 (TLALOC-2)

June 25, 2026 updated by: José Antonio Mata Marín, Instituto Mexicano del Seguro Social
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This was a phase IV, open-label, single-center pilot clinical trial conducted from March 2025 to March 2026 at the HIV Clinic of the "La Raza" Infectious Diseases Hospital, National Medical Center, in Mexico City. This tertiary care center provides services to patients with social security coverage. The study protocol was approved by the Local Health Research Committee of the Mexican Social Security Institute (3502) and the Research Ethics Committee (35028; R-2025-3502-183). Written informed consent was obtained from all participants to mantained DRV/c + 3TC or switching from TDF/FTC to TAF/FTC.

Study population: Eligible participants were adult males ≥18 years old living with HIV-1 who had maintained virological suppression on either dual therapy with DRV/c + 3TC or triple therapy with DRV/c + TDF/FTC for 48 weeks prior to enrollment (TLALOC-1 trial), and had an estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m² calculated by the CKD-EPI equation.

Exclusion criteria in TLALOC-1 included history of prior virological failure, baseline genotypic resistance mutations to any component of the study regimens, active malignancy, or coinfection with hepatitis B virus (HBV) or hepatitis C virus (HCV).

Treatment allocation: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.

Outcomes: For this preliminary analysis, the primary efficacy endpoint was the proportion of participants with HIV-1 RNA ≥50 copies/mL at week 24. (TLALOC-2 continues recruitment; the primary endpoint for the full study is effectiveness and safety at 48 and 96 weeks of follow-up). This was confirmed in two consecutive determinations, according to the FDA Snapshot algorithm. Participants were classified into three mutually exclusive categories.

  1. HIV-1 RNA ≥50 copies/ml at week 24, discontinuation of the study drug before week 24 due to lack of efficacy, or discontinuation for reasons other than lack of efficacy, adverse events, or death with the last available HIV-1 RNA value ≥50 copies/ml.
  2. HIV-1 RNA <50 copies/ml at week 24.
  3. No virological data, participants who discontinued the study drug before week 24 due to adverse events or death; participants who discontinued treatment for reasons other than lack of efficacy, adverse events or death, with the last available HIV-1 RNA value less than 50 copies/ml; or participants who were still receiving the study drug but with missing HIV-1 RNA data at week 24.

Safety was assessed through physical examinations and laboratory tests. AEs were defined as any unfavorable and unintended sign including abnormal laboratory findings, symptom, or disease temporally associated with the use of the study treatment, regardless of causality. The incidence and severity of AEs were graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1, July 2017) and assessed at baseline, week 12, and week 24.

Secondary endpoints included change in CD4+ cell count from baseline to week 24, and changes in renal function parameters, including estimated GFR (calculated using the CKD-EPI formula with cystatin C), urinary phosphorus excretion fraction, urinary uric acid excretion fraction, and serum creatinine levels.

Procedures: Laboratory assessments were performed at baseline and at weeks 4, 12, and 24. Tests included complete blood count, blood chemistry, liver function tests, fasting lipid profile, biomarkers of renal and bone metabolism (serum creatinine, cystatin C, estimated glomerular filtration rate [eGFR], urinary and serum electrolytes), CD4+ cell count, and HIV-1 RNA viral load (RT-PCR, M2000, Abbott).

Adherence was assessed using the AIDS Clinical Trials Group (ACTG) adherence questionnaire, administered at each visit. Treatment satisfaction and symptom burden were evaluated with the HIV Treatment Satisfaction Questionnaire (HIVTSQ) and the HIV Symptom Distress Module (HIV-SDM). Neuropsychological status was assessed at baseline and at weeks 12 and 24 using the Hospital Anxiety and Depression Scale (HADS-A and HADS-D), the Patient Health Questionnaire-9 (PHQ-9), and the Insomnia Severity Index (ISI). Safety was monitored at every visit through direct questioning and clinical evaluation, with AEs categorized by organ system according to DAIDS criteria.

Statistical analysis: Baseline and 24-week follow-up outcomes were analyzed. Continuous variables were expressed as means with standard deviations or medians with interquartile ranges, depending on normality assessed by the Kolmogorov-Smirnov test. Categorical variables were presented as frequencies and percentages.

Between-group comparisons of continuous variables were performed using the independent Student's t-test in case of normal distribution or Mann-Whitney U test in case of non-normal distribution. Within-group changes from baseline to week 24 were analyzed with paired t-tests or Wilcoxon signed-rank tests, as appropriate. Associations between categorical variables were evaluated using the chi-square test or Fisher's exact test. Variables showing statistical significance in bivariare analyses were further examined using binary logistic regression model. For safety analyses, baseline characteristics were summarized using descriptive statistics for all participants who received at least one dose of study medication. A p-value ≤0.05 was considered statistically significant. All analyses were performed using SPSS software (version 29; IBM Corp., Armonk, NY, USA).

Ethical considerations: The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. The protocol was approved by the Health Research Ethics Committee 3502 of the Hospital de Infectología "La Raza" National Medical Center (protocol number R-2025-3502-183). All participants received detailed information about the study purpose, procedures, potential risks, and benefits, and were informed of their right to withdraw at any time without affecting their standard medical care.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 02990
        • Recruiting
        • Hospital de Infectología "Dr Daniel Méndez Hernández" National Medical Center "La Raza", Instituto Mexicano del Seguro Social
        • Contact:
        • Principal Investigator:
          • Sandra Patricia Ramírez Eguia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dual therapy: darunavir/cobicistat + lamivudine
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
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.
Other Names:
  • DRV/C+3TC
Experimental: Triple therapy: darunavir/cobicistat plus tenofovir alafenamide/emtricitabine
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
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.
Other Names:
  • DRV/c+TAF/FTC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness
Time Frame: at 24 and 48 weeks
HIV-1 RNA ≥50 copies/mL
at 24 and 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: at 24 and 48 weeks
Safety was monitored at every visit through direct questioning and clinical evaluation, categorized by organ system according to DAIDS criteria Division of AIDS Drug-Associated Adverse Event Severity Scale (DAIDS), which classifies them on a scale of 1 to 4. Grade 1: Mild or no harm; Grade 2: Moderate adverse events or minimal interference with social and functional activities; Grade 3: Severe symptoms causing inability to perform social/functional activities or requiring hospitalization; Grade IV: Life-threatening events with symptoms causing inability to perform basic self-care and where intervention is required to prevent permanent deterioration or death.
at 24 and 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Investigators

  • Principal Investigator: Sandra Patricia Ramírez Eguia, Instituto Mexicano del Seguro Social

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2025

Primary Completion (Estimated)

July 10, 2026

Study Completion (Estimated)

December 10, 2026

Study Registration Dates

First Submitted

June 25, 2026

First Submitted That Met QC Criteria

June 25, 2026

First Posted (Actual)

July 1, 2026

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2025-3502-183 (Other Identifier: Instituto Mexicano Del Seguro Social)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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