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

HIV Infection Clinical Trial

— DUAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02159599
• Other study ID #: GESIDA 8014
• Secondary ID: 2014-000515-14
• Status: Completed
• Phase: Phase 4
• First received: May 27, 2014
• Last updated: February 13, 2017
• Start date: July 2014
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Fundacion SEIMC-GESIDA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 with suppressed plasma viremia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Drug:
• Darunavir/Ritonavir
Darunavir/ritonavir (800/100 mg): QD (quaque die )
• Lamivudine
Lamivudine (300mg) : QD
• Emtricitabine/tenofovir or abacavir/lamivudine
Emtricitabine/tenofovir (300/200 mg) or abacavir/lamivudine (600/300 mg): QD

Locations

Country	Name	City	State
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	Hospital Universitario de Bellvitge	Hospitalet de Llobregat	Barcelona
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 Universitario Virgen de la Victoria	Málaga
Spain	Hospital de Mataró	Mataró
Spain	Hospital Universitario Donostia	San Sebastián
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion SEIMC-GESIDA	Janssen, LP

Country where clinical trial is conducted

Spain, 

Outcome

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