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HIV InfectionPhase 4DUALNCT02159599

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

A Phase 4 study testing Darunavir/Ritonavir, Lamivudine and Emtricitabine/tenofovir or abacavir/lamivudine in people with HIV Infection, run by Fundacion SEIMC-GESIDA at 21 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infection
What is being tested?
Darunavir/Ritonavir, Lamivudine and Emtricitabine/tenofovir or abacavir/lamivudine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
249 participants
Where
21 sitesSpain
Study dates
Jul 2014to Apr 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 13Show fewer
  • 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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Spain21 sites

  • Hospital General Universitario de Alicante

    Alicante

  • Hospital Universitario Germans Trias i Pujol

    Badalona

  • Hospital Clinic

    Barcelona

  • Hospital de La Santa Creu I Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Universitario Vall D'Hebron

    Barcelona

  • Hospital Universitario Reina Sofía

    Córdoba

  • Hospital Universitario Virgen de las Nieves

    Granada

  • Complejo Hospitalario de Huelva

    Huelva

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona

  • Hospital 12 de Octubre

    Madrid

  • Hospital Universitario Clínico San Carlos

    Madrid

  • Hospital Universitario Fundación Alcorcón

    Madrid

  • Hospital Universitario Gregorio Marañón

    Madrid

  • Hospital universitario Infanta Leonor

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Príncipe de Asturias

    Madrid

  • Hospital Universitario Virgen de la Victoria

    Málaga

  • Hospital de Mataró

    Mataró

  • Hospital Universitario Donostia

    San Sebastián

  • Hospital Universitario Miguel Servet

    Zaragoza

Other trials in Spain

About this study

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

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.

Conditions
HIV Infection
Being tested
Darunavir/Ritonavir, Lamivudine, Emtricitabine/tenofovir or abacavir/lamivudine
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Darunavir/RitonavirDrug

    Also called Prezista/Norvir

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

  • LamivudineDrug

    Also called Epivir

    Lamivudine (300mg) : QD

  • Emtricitabine/tenofovir or abacavir/lamivudineDrug

    Also called Truvada or Kivexa

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

Study groups in NCT02159599
Study groupRoleWhat they receive
Darunavir/Ritonavir + 2 nucleos(t)idosActive comparatorDarunavir/Ritonavir ( (800mg/100mg) + Tenofovir/emtricitabine (300mg/200mg) or Abacavir/lamivudine (600 mg/300mg)
Receives: Drug: Darunavir/Ritonavir; Drug: Emtricitabine/tenofovir or abacavir/lamivudine
Darunavir/ritonavir + LamivudineExperimentalDarunavir/Ritonavir (800mg7100mg) + lamivudine (300mg)
Receives: Drug: Darunavir/Ritonavir; Drug: Lamivudine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with undetectable viral load

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

    Measured: week 48

Secondary outcomes (9)

  1. Proportion of patients with undetectable viral load

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

    Measured: Week 24

  2. Proportion of patients with viral load < 200 copies/ml

    Proportion of patients with viral load < 200 copies/ml according to FDA snapshot algorithm

    Measured: week 48

  3. Proportion of patients who present viral load ≥ 50 copies /ml one time

    Viral load ≥ 50 copies/ml

    Measured: From basal visit until week 48 visit

  4. Proportion of patients who present viral load ≥ 50 copies /ml more tan two times

    Viral load ≥ 50 copies /ml

    Measured: From basal visit until week 48 visit

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

    Viral load < 50 copies/ml

    Measured: week 48

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

    CD4/µl

    Measured: week 48

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

    Measured: week 48

  8. Change in renal function

    Change in glomerular filtration

    Measured: week 48

  9. Change in proportion of patients with renal tubular dysfunction

    Measured: week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
249 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02159599
Sponsor's protocol ID
GESIDA 8014
Other IDs
2014-000515-14, 2014
Acronym
DUAL
Status last verified
Jun 2016
First submitted
27 May 2014
Last updated
14 Feb 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29020293

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Darunavir/Ritonavir, Lamivudine and Emtricitabine/tenofovir or abacavir/lamivudine in people with HIV Infection, run by Fundacion SEIMC-GESIDA at 21 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with undetectable viral load (time frame: week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02159599, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.

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