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OpenTrials
Completed

NCT Number: NCT02159599

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acceptance to participate in the study, signing the informed consent document before conducting any study procedures.
  • Patient with HIV infection older than 18 years.
  • Treatment with darunavir/ritonavir once a day and tenofovir/emtricitabine or abacavir/lamivudine during at least 4 weeks at the moment of the screening
  • 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).
  • 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

Treatment and study plan

Darunavir/ritonavir

Drug

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

Other names: Prezista/Norvir

Lamivudine

Drug

Lamivudine (300mg) : QD

Other names: Epivir

Emtricitabine/tenofovir or abacavir/lamivudine

Drug

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

Other names: Truvada or Kivexa

Primary outcomes

  1. Proportion of patients with undetectable viral load

    Time frame: week 48

    Undetectable viral load <50 copies/ml according to the FDA snapshot algorithm

Secondary outcomes

  1. Proportion of patients with undetectable viral load

    Time frame: Week 24

    Undetectable viral load < 50 copies/ml according to the FDA snapshot algorithm

  2. 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

  3. 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

  4. 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

  5. Proportion of patients who maintained viral load < 50 copies/ml in all determinations

    Time frame: week 48

    Viral load < 50 copies/ml

  6. Median of change cells CD4/µl count from basal to week 48

    Time frame: week 48

    CD4/µl

  7. Median of change in triglycerides , LDL-cholesterol, HDL-cholesterol and total cholesterol from basal to week 48

    Time frame: week 48

  8. Change in renal function

    Time frame: week 48

    Change in glomerular filtration

  9. Change in proportion of patients with renal tubular dysfunction

    Time frame: week 48

Other outcomes

  1. Proportion of genotypic resistance mutations

    Time frame: Week 48

    Mutations in patients viral failure

  2. Change in proportion of genotypic resistance mutations

    Time frame: week 48

Sponsors and collaborators

Lead sponsor

Fundacion SEIMC-GESIDA

Other

Collaborators

  • Janssen, LP

Registry information

Official study 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

Acronym: DUAL

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 10, 2014
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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