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

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ClinicalTrials.gov Identifier: NCT02159599
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : February 14, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infection Drug: Darunavir/Ritonavir Drug: Lamivudine Drug: Emtricitabine/tenofovir or abacavir/lamivudine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
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
Study Start Date : July 2014
Primary Completion Date : April 2016
Study Completion Date : April 2016


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:

  1. Pregnant or breastfeeding woman
  2. 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).
  3. 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.
  4. 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 .

  5. Previous treatment with bitherapy or monotherapy with lamivudine or emtricitabine
  6. 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.
  7. The use of concomitant medication not permitted
  8. Presence of active acute infection, including opportunist infection that a judge of investigator that can difficult the participation in the trial
  9. 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)
  10. Any clinical or analytic event that, in the investigator judgment, condition the patient safety
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier: NCT02159599     History of Changes
Other Study ID Numbers: GESIDA 8014
2014-000515-14 ( EudraCT Number )
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: June 2016

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Darunavir
Tenofovir
Lamivudine
Emtricitabine
Abacavir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Dideoxynucleosides
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Antimetabolites