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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Fundacion SEIMC-GESIDA
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier:
NCT02159599
First received: May 27, 2014
Last updated: June 6, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Fundacion SEIMC-GESIDA:

Primary Outcome Measures:
  • Proportion of patients with undetectable viral load [ Time Frame: week 48 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Viral load ≥ 50 copies /ml

  • Proportion of patients who maintained viral load < 50 copies/ml in all determinations [ Time Frame: week 48 ] [ Designated as safety issue: No ]
    Viral load < 50 copies/ml

  • Median of change cells CD4/µl count from basal to week 48 [ Time Frame: week 48 ] [ Designated as safety issue: No ]
    CD4/µl

  • Median of change in triglycerides , LDL-cholesterol, HDL-cholesterol and total cholesterol from basal to week 48 [ Time Frame: week 48 ] [ Designated as safety issue: Yes ]
  • Change in renal function [ Time Frame: week 48 ] [ Designated as safety issue: Yes ]
    Change in glomerular filtration

  • Change in proportion of patients with renal tubular dysfunction [ Time Frame: week 48 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Proportion of genotypic resistance mutations [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Mutations in patients viral failure

  • Change in proportion of genotypic resistance mutations [ Time Frame: week 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 256
Study Start Date: June 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

Contacts
Contact: Maria Yllescas 0034 91 556 8025 myllescas@f-sg.org
Contact: Herminia Esteban 0034 91 556 8025 hesteban@f-sg.org

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 Universitario Vall D'Hebron
Barcelona, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Clinic
Barcelona, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Complejo Hospitalario de Huelva
Huelva, Spain
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain
Principal Investigator: José R Arribas, MD         
Hospital universitario Infanta Leonor
Madrid, Spain
Hospital Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario Príncipe de Asturias
Madrid, Spain
Hospital Universitario Fundación Alcorcón
Madrid, Spain
Hospital Universitario Clínico San Carlos
Madrid, Spain
Hospital 12 de Octubre Not yet recruiting
Madrid, Spain
Principal Investigator: Federico Pulido, MD         
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

No publications provided

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: June 6, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lamivudine
Tenofovir
Tenofovir disoproxil
Abacavir
Ritonavir
Darunavir
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014