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

NCT06907056 | Recruiting Phase 4

• 1 other identifier: R-2024-3502-116
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV; dual therapy; DRV/c+3TC; effectiveness; non-inferiority

Outcome Measures

Primary Outcomes (1)

• Effectiveness

  Individuals with \>50 copies/ml

  48 weeks

Secondary Outcomes (2)

• Non-inferiority

  48 weeks

• Safety

  48 weeks

Study Arms (2)

Standar therapy

ACTIVE COMPARATOR

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

Dual therapy

EXPERIMENTAL

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

Interventions

dual therapy DRUG

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

Also known as: DRV/c+3TC

Dual therapy

Standard Medical Therapy DRUG

DRV/c+TDF/FTC

Also known as: DRV/c+TDF/FTC

Standar therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• José Antonio Mata Marín: lead

Study Sites (1)

Hospital de Infectología, Centro Médico Nacional La Raza

Mexico City, Mexico City, 02990, Mexico

RECRUITING

Related Publications (9)

• Figueroa MI, Sued O, Cecchini D, Sanchez M, Rolon MJ, Lopardo G, Ceschel M, Mernies G, De Stefano M, Patterson P, Gun A, Fink V, Ortiz Z, Cahn P; ANDES Study Group. Dual therapy based on co-formulated darunavir/ritonavir plus lamivudine for initial therapy of HIV infection: The ANDES randomized controlled trial. Int J Antimicrob Agents. 2024 Oct;64(4):107301. doi: 10.1016/j.ijantimicag.2024.107301. Epub 2024 Aug 14.

  PMID: 39151647 BACKGROUND

• Pulido F, Ribera E, Lagarde M, Perez-Valero I, Palacios R, Iribarren JA, Payeras A, Domingo P, Sanz J, Cervero M, Curran A, Rodriguez-Gomez FJ, Tellez MJ, Ryan P, Barrufet P, Knobel H, Rivero A, Alejos B, Yllescas M, Arribas JR; DUAL-GESIDA-8014-RIS-EST45 Study Group. Dual Therapy With Darunavir and Ritonavir Plus Lamivudine vs Triple Therapy With Darunavir and Ritonavir Plus Tenofovir Disoproxil Fumarate and Emtricitabine or Abacavir and Lamivudine for Maintenance of Human Immunodeficiency Virus Type 1 Viral Suppression: Randomized, Open-Label, Noninferiority DUAL-GESIDA 8014-RIS-EST45 Trial. Clin Infect Dis. 2017 Nov 29;65(12):2112-2118. doi: 10.1093/cid/cix734.

  PMID: 29020293 BACKGROUND

• Fabbiani M, Gagliardini R, Ciccarelli N, Quiros Roldan E, Latini A, d'Ettorre G, Antinori A, Castagna A, Orofino G, Francisci D, Chinello P, Madeddu G, Grima P, Rusconi S, Del Pin B, Lombardi F, D'Avino A, Foca E, Colafigli M, Cauda R, Di Giambenedetto S, De Luca A; ATLAS-M Study Group. Atazanavir/ritonavir with lamivudine as maintenance therapy in virologically suppressed HIV-infected patients: 96 week outcomes of a randomized trial. J Antimicrob Chemother. 2018 Jul 1;73(7):1955-1964. doi: 10.1093/jac/dky123.

  PMID: 29668978 BACKGROUND

• Perez-Molina JA, Rubio R, Rivero A, Pasquau J, Suarez-Lozano I, Riera M, Estebanez M, Santos J, Sanz-Moreno J, Troya J, Marino A, Antela A, Navarro J, Esteban H, Moreno S; GESIDA 7011 Study Group. Dual treatment with atazanavir-ritonavir plus lamivudine versus triple treatment with atazanavir-ritonavir plus two nucleos(t)ides in virologically stable patients with HIV-1 (SALT): 48 week results from a randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2015 Jul;15(7):775-84. doi: 10.1016/S1473-3099(15)00097-3. Epub 2015 Jun 7. Erratum In: Lancet Infect Dis. 2015 Sep;15(9):998. doi: 10.1016/S1473-3099(15)00241-8.

  PMID: 26062881 BACKGROUND

• Cahn P, Andrade-Villanueva J, Arribas JR, Gatell JM, Lama JR, Norton M, Patterson P, Sierra Madero J, Sued O, Figueroa MI, Rolon MJ; GARDEL Study Group. Dual therapy with lopinavir and ritonavir plus lamivudine versus triple therapy with lopinavir and ritonavir plus two nucleoside reverse transcriptase inhibitors in antiretroviral-therapy-naive adults with HIV-1 infection: 48 week results of the randomised, open label, non-inferiority GARDEL trial. Lancet Infect Dis. 2014 Jul;14(7):572-80. doi: 10.1016/S1473-3099(14)70736-4. Epub 2014 Apr 27.

  PMID: 24783988 BACKGROUND

• Achhra AC, Mwasakifwa G, Amin J, Boyd MA. Efficacy and safety of contemporary dual-drug antiretroviral regimens as first-line treatment or as a simplification strategy: a systematic review and meta-analysis. Lancet HIV. 2016 Aug;3(8):e351-e360. doi: 10.1016/S2352-3018(16)30015-7. Epub 2016 May 31.

  PMID: 27470027 BACKGROUND

• Corado KC, Caplan MR, Daar ES. Two-drug regimens for treatment of naive HIV-1 infection and as maintenance therapy. Drug Des Devel Ther. 2018 Nov 1;12:3731-3740. doi: 10.2147/DDDT.S140767. eCollection 2018.

  PMID: 30464404 BACKGROUND

• Trujillo-Rodriguez M, Munoz-Muela E, Serna-Gallego A, Milanes-Guisado Y, Praena-Fernandez JM, Alvarez-Rios AI, Herrera-Hidalgo L, Dominguez M, Lozano C, Romero-Vazquez G, Roca C, Espinosa N, Gutierrez-Valencia A, Lopez-Cortes LF. Immunological and inflammatory changes after simplifying to dual therapy in virologically suppressed HIV-infected patients through week 96 in a randomized trial. Clin Microbiol Infect. 2022 Aug;28(8):1151.e9-1151.e16. doi: 10.1016/j.cmi.2022.02.041. Epub 2022 Mar 11.

  PMID: 35289296 BACKGROUND

• Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring: Recommendations for a Public Health Approach [Internet]. Geneva: World Health Organization; 2021 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK572729/

  PMID: 34370423 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Dual Anti-Platelet Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Model Details: Unicenter, open-label, randomized, noninferiority trial, 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, 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 Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: November 9, 2023
• Primary Completion: February 28, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)