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

NCT ID: NCT02159599

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-04-30

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.

Conditions

HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Darunavir/Ritonavir + 2 nucleos(t)idos

Darunavir/Ritonavir ( (800mg/100mg) + Tenofovir/emtricitabine (300mg/200mg) or Abacavir/lamivudine (600 mg/300mg)

Group Type: ACTIVE_COMPARATOR

Darunavir/Ritonavir

Intervention Type: DRUG

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

Emtricitabine/tenofovir or abacavir/lamivudine

Intervention Type: DRUG

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

Darunavir/ritonavir + Lamivudine

Darunavir/Ritonavir (800mg7100mg) + lamivudine (300mg)

Group Type: EXPERIMENTAL

Darunavir/Ritonavir

Intervention Type: DRUG

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

Lamivudine

Intervention Type: DRUG

Lamivudine (300mg) : QD

Interventions

Darunavir/Ritonavir

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

Intervention Type: DRUG

Lamivudine

Lamivudine (300mg) : QD

Intervention Type: DRUG

Emtricitabine/tenofovir or abacavir/lamivudine

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

Intervention Type: DRUG

Other Intervention Names

Prezista/Norvir; Epivir; Truvada or Kivexa

Eligibility 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).

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen, LP

INDUSTRY

Sponsor Role: collaborator

Fundacion SEIMC-GESIDA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose R Arribas, MD

Role: STUDY_DIRECTOR

Hospital Universitario La Paz

Federico Pulido, MD

Role: STUDY_DIRECTOR

Hospital Universitario 12 de Octubre

Esteban Ribera, MD

Role: STUDY_DIRECTOR

Hospital Vall d'Hebron

Locations

Hospital Universitario de Bellvitge

L'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

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 29020293 (View on PubMed)

Other Identifiers

2014-000515-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GESIDA 8014

Identifier Type: -

Identifier Source: org_study_id