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

April 1, 2025 updated by: José Antonio Mata Marín

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Subject to prior approval of the protocol by the local scientific research ethics committee and the relevant agencies, patients being monitored at the HIV clinic at the Infectious Diseases Hospital of the CMN "La Raza" who are living with HIV and receiving treatment with DRV/c + TFV/FTC for virological suppression will be identified as candidates for participation in the study.

They will be invited to participate in the study protocol, and the project and its likely outcomes will be explained in detail to the subjects. It will be explained that treatment assignment will be randomized using the digital system (MEDSHARING: randomizer for clinical trials) to one of two arms:

  1. DRV/c (800 mg/150 mg once daily) + 3TC (300 mg once daily) or
  2. DRV/c (800 mg/150 mg once daily) + TFV/FTC (300 mg/200 mg once daily). Answers will be obtained during the medical interview, allowing the patient to freely decide whether to continue or withdraw from the study during the study period without affecting their medical care at the HIV clinic. Informed consent will be obtained, and to maintain privacy, a patient ID number will be assigned at the time of recruitment. Weight (kg), height (cm), body mass index (BMI) (kg/height (m2), body composition (fat, water, muscle, kg, bone, kg) will be measured using the FitScan BC-545F segmental body composition monitor, and waist and hip measurements will be measured using a tape measure. Laboratory studies will include a complete blood count, complete blood chemistry with glucose and creatinine, a complete lipid profile, and post-randomization liver function tests at 4 weeks, 12 weeks, 24 weeks, and 48 weeks post-switch. CD4+ and HIV-1 RNA determinations will be performed prior to randomization, and at 3 months, 6 months, and 12 months post-study entry. Comparisons will be made between measurements taken prior to entry, 24 weeks, and 48 weeks post-study entry. Serum electrolytes (phosphorus, magnesium, calcium), cystatin C, and urinary electrolytes (phosphorus, magnesium, calcium, creatinine, urea, microproteins) will be measured prior to randomization and at 24 and 48 weeks post-switch.

If patients present with elevated AST and/or ALT >90 IU/L, serology tests will be ordered to rule out HBV and HCV.

The ISI, PHQ-9, HADS-A, and HADS-D questionnaires will be administered to assess anxiety, depression, and sleep quality. Additionally, the HIVTSQ questionnaire will be administered to assess treatment satisfaction at weeks 4, 12, 24, and 48 weeks post-randomization, and the HIV-SDM questionnaire will be administered to assess HIV-related symptoms and distress. At each medical visit, potential drug-related adverse effects will be deliberately inquired about by device and system, and will be classified into four grades using the DAIDS adverse event scale.

Study Type

Interventional

Enrollment (Estimated)

138

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 Locations

  • Mexico
    • Cdmx
      • Mexico city, Cdmx, Mexico, 02990
        • Recruiting
        • Hospital de infectología, Centro Médico Nacional La Raza
        • Contact:
          • Ana L Cano, postgraduate
        • Contact:
        • Contact:
        • Contact:
          • José A Mata, Master degree

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:

  • 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.

Exclusion Criteria:

  • Withdrawal of informed consent
  • Loss of medical insurance
  • Presence of tuberculosis or other opportunistic infection requiring adjustment of the ARV regimen
  • Incomplete data collected during visits Uncontrolled chronic gastrointestinal conditions Desire to be on a single-dose regimen Coinfection with hepatitis B virus during follow-up if in the DRV/3TC arm Coinfection with hepatitis C virus during follow-up

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Standard Medical Therapy
DRV/c+TDF/FTC
Other Names:
  • DRV/c+TDF/FTC
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
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
Other Names:
  • DRV/c+3TC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness
Time Frame: 48 weeks
Individuals with >50 copies/ml
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-inferiority
Time Frame: 48 weeks
Delta between standard and experimental therapy <10%
48 weeks
Safety
Time Frame: 48 weeks
Adverse events by group and drug tolerability will be reported by device and system, and their severity will be based on the Division of AIDS (DAIDS) Antiretroviral Drug-Associated Adverse Event Severity Scale, which categorizes them in severity from 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: Those that are life-threatening with symptoms causing inability to perform basic self-care and where intervention is required to prevent permanent deterioration or death.
48 weeks

Collaborators and Investigators

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

Sponsor

José Antonio Mata Marín

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)

November 9, 2023

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

March 26, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2024-3502-116 (Other Identifier: Instituto Mexicano Del Seguro Social)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data cannot be shared openly because it contains personal information about the participants; if required, it can be requested from the corresponding author.

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.

No

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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