Clinical Trials

MainTitle

Study to Evaluate Darunavir/Ritonavir + Lamivudine Versus Continuing With Darunavir/Ritonavir + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject (DUAL)

This study has been completed
Sponsor
Fundacion SEIMC-GESIDA

Collaborator
Janssen, LP

Information provided by (Responsible Party)
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier
NCT02159599

First received: May 27, 2014
Last updated: February 13, 2017
Last Verified: June 2016
History of Changes
Purpose

Purpose

This is an open label randomized clinial trial to evaluate the treatment with darunavir/ritonavir (800mg/100mg) plus lamivudine (300 mg) once daily versus continuing with darunavir/ritonavir (800mg/100mg) once daily plus tenofovir/emtricitabine (300mg/200mg) or abacavir/lamivudine (600mg/300mg) in HIV infected subject with suppressed plasma viremia.

Condition Intervention Phase
HIV Infection

Drug : Darunavir/Ritonavir
Drug : Lamivudine
Drug : Emtricitabine/tenofovir or abacavir/lamivudine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Open Label Randomized Clinical Trial, to Evaluate the Treatment With Darunavir/Ritonavir + Lamivudine Once Daily Versus Continuing With Darunavir/Ritonavir Once Daily + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject With Suppressed Plasma Viremia

Further study details as provided by Fundacion SEIMC-GESIDA:

Primary Outcome Measures

  • Proportion of patients with undetectable viral load [ Time Frame: week 48 ]
    Undetectable viral load <50 copies/ml according to the FDA snapshot algorithm
Secondary Outcome Measures:
  • Proportion of patients with undetectable viral load [ Time Frame: Week 24 ]
    Undetectable viral load < 50 copies/ml according to the FDA snapshot algorithm
  • Proportion of patients with viral load < 200 copies/ml [ Time Frame: week 48 ]
    Proportion of patients with viral load < 200 copies/ml according to FDA snapshot algorithm
  • Proportion of patients who present viral load ≥ 50 copies /ml one time [ Time Frame: From basal visit until week 48 visit ]
    Viral load ≥ 50 copies/ml
  • Proportion of patients who present viral load ≥ 50 copies /ml more tan two times [ Time Frame: From basal visit until week 48 visit ]
    Viral load ≥ 50 copies /ml
  • Proportion of patients who maintained viral load < 50 copies/ml in all determinations [ Time Frame: week 48 ]
    Viral load < 50 copies/ml
  • Median of change cells CD4/µl count from basal to week 48 [ Time Frame: week 48 ]
    CD4/µl
  • Median of change in triglycerides , LDL-cholesterol, HDL-cholesterol and total cholesterol from basal to week 48 [ Time Frame: week 48 ]
  • Change in renal function [ Time Frame: week 48 ]
    Change in glomerular filtration
  • Change in proportion of patients with renal tubular dysfunction [ Time Frame: week 48 ]
Other Outcome Measures:
  • Proportion of genotypic resistance mutations [ Time Frame: Week 48 ]
    Mutations in patients viral failure
  • Change in proportion of genotypic resistance mutations [ Time Frame: week 48 ]

Enrollment: 249
Study Start Date: July 2014
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Darunavir/Ritonavir + 2 nucleos(t)idos
Darunavir/Ritonavir ( (800mg/100mg) + Tenofovir/emtricitabine (300mg/200mg) or Abacavir/lamivudine (600 mg/300mg)
Drug: Darunavir/Ritonavir

Darunavir/ritonavir (800/100 mg): QD (quaque die )

Other Name: Prezista/Norvir
Drug: Emtricitabine/tenofovir or abacavir/lamivudine

Emtricitabine/tenofovir (300/200 mg) or abacavir/lamivudine (600/300 mg): QD

Other Name: Truvada or Kivexa
Experimental: Darunavir/ritonavir + Lamivudine
Darunavir/Ritonavir (800mg7100mg) + lamivudine (300mg)
Drug: Darunavir/Ritonavir

Darunavir/ritonavir (800/100 mg): QD (quaque die )

Other Name: Prezista/Norvir
Drug: Lamivudine

Lamivudine (300mg) : QD

Other Name: Epivir
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  1. Acceptance to participate in the study, signing the informed consent document before conducting any study procedures.
  2. Patient with HIV infection older than 18 years.
  3. Treatment with darunavir/ritonavir once a day and tenofovir/emtricitabine or abacavir/lamivudine during at least 4 weeks at the moment of the screening
  4. Plasma HIV RNA levels below 50 copies / ml for at least 6 months (two separate measurements at least 6 months with viremia <50 copies / ml between both).
  5. HbsAg negative

  • Exclusion Criteria:
  • Pregnant or breastfeeding woman
  • Evidence of Lamivudine resistance (any previous genotype with mutation M184V/I or K65R) and/or to darunavir (population genotype show any of the following mutations: V11I, V32I, L33F, I47V, I50V, I54L/M, G73S, T74P, L76V, I84V, L89V).
  • History of virology failure (two consecutive viral loads above 200 copies/ml) while the patient was receiving a regimen with lamivudine or emtricitabine, with the following exceptions:
    • Do not consider an exclusion criterion if the genotype performed at the time of failure does not demonstrate resistance to lamivudine and darunavir (see criteria 2).
    • Do not consider an exclusion criteria in the absence of genotype if after the episode turns to maintain a viral load <50 copies / ml with a treatment composed of lamivudine or emtricitabine + a nucleoside + a non-nucleoside.
  • History of abandonment of treatment including lamivudine or emtricitabine, with the following exception:
    • Viral load prior to abandonment was <50 copies / ml and subsequent reintroduction of the same treatment or another treatment consisting of lamivudine or emtricitabine + a nucleoside + a non-nucleoside returns to maintain viral load below 50 copies / ml .
  • Previous treatment with bitherapy or monotherapy with lamivudine or emtricitabine
  • Previous treatment with bitherapy or monotherapy with a regimen with a protease inhibitor that is terminated by viral rebound, when the absence of a genotypic resistance test available after viral rebound allow discard the resistance mutations either drug used.
  • The use of concomitant medication not permitted
  • Presence of active acute infection, including opportunist infection that a judge of investigator that can difficult the participation in the trial
  • Any laboratory results of the following: hemoglobin<8,0 g/dl; neutrophils <750 cells/µl; platelets <50.000 cell/µl; creatinine ≥ 1,5 ULN (upper limit of normal)
  • Any clinical or analytic event that, in the investigator judgment, condition the patient safety

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT02159599

    Locations

    Spain
    Hospital Universitario de Bellvitge
    Hospitalet de Llobregat, Barcelona, Spain
    Hospital General Universitario de Alicante
    Alicante, Spain
    Hospital Universitario Germans Trias i Pujol
    Badalona, Spain
    Hospital Clinic
    Barcelona, Spain
    Hospital de La Santa Creu I Sant Pau
    Barcelona, Spain
    Hospital del Mar
    Barcelona, Spain
    Hospital Universitario Vall D'Hebron
    Barcelona, Spain
    Hospital Universitario Reina Sofía
    Córdoba, Spain
    Hospital Universitario Virgen de las Nieves
    Granada, Spain
    Complejo Hospitalario de Huelva
    Huelva, Spain
    Hospital 12 de Octubre
    Madrid, Spain
    Hospital Universitario Clínico San Carlos
    Madrid, Spain
    Hospital Universitario Fundación Alcorcón
    Madrid, Spain
    Hospital Universitario Gregorio Marañón
    Madrid, Spain
    Hospital universitario Infanta Leonor
    Madrid, Spain
    Hospital Universitario La Paz
    Madrid, Spain
    Hospital Universitario Príncipe de Asturias
    Madrid, Spain
    Hospital de Mataró
    Mataró, Spain
    Hospital Universitario Virgen de la Victoria
    Málaga, Spain
    Hospital Universitario Donostia
    San Sebastián, Spain
    Hospital Universitario Miguel Servet
    Zaragoza, Spain

    Sponsors and Collaborators

    Fundacion SEIMC-GESIDA
    Janssen, LP

    Investigators

    Study Director: Jose R Arribas, MD Hospital Universitario La Paz
    Study Director: Federico Pulido, MD Hospital Universitario 12 de Octubre
    Study Director: Esteban Ribera, MD Hospital Vall d'Hebron
    More Information

    More Information


    Responsible Party: Fundacion SEIMC-GESIDA  
    ClinicalTrials.gov Identifier: NCT02159599   History of Changes  
    Other Study ID Numbers: GESIDA 8014  
      2014-000515-14  
    Study First Received: May 27, 2014  
    Last Updated: February 13, 2017  

    Additional relevant MeSH terms:
    HIV Infections
    Ritonavir
    Darunavir
    Tenofovir
    Lamivudine
    Emtricitabine
    Abacavir
    Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
    Dideoxynucleosides

    ClinicalTrials.gov processed this data on December 15, 2017
    This information is provided by ClinicalTrials.gov.