Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy

NCT ID: NCT01307488

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-03-31

Brief Summary

A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected subjects in their first antiretroviral regimen and who are virologically suppressed on a regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to ATV/RTV 300/100 mg QD + 2 optimized NRTIs for maintenance of virological suppression.

Detailed Description

Clinical Trial, phase IV, randomized, open label, multicenter with approved drugs in their use conditions.

A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected subjects in their first antiretroviral regimen and who are virologically suppressed on a regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to ATV/RTV 300/100 mg QD + 2 optimized NRTIs for maintenance of virological suppression.

Conditions

HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ATV/r+3TC

Subjects will receive ATV/RTV 300/100 mg QD + 2 optimized NRTIs for the first 4 weeks and then they will receive ATV/RTV 300/100 mg QD (once daily) and 3TC 300 mg QD for another 92 weeks. Treatment should be taken orally with a light meal at the same time each day.

Group Type: EXPERIMENTAL

Ritonavir boosted Atazanavir + Lamivudine

Intervention Type: DRUG

ATV/RTV 300/100 mg QD + 2 optimized NRTIs for the first 4 weeks and then they will receive ATV/RTV 300/100 mg QD (once daily) and 3TC 300 mg QD for another 92 weeks. Treatment should be taken orally with a light meal at the same time each day.

ATV/r+2 NRTIs

Subjects will receive ATV/RTV 300/100 mg QD + 2 optimized NRTIs for 96 weeks. Treatment should be taken orally with a light meal at the same time each day.

Group Type: ACTIVE_COMPARATOR

Ritonavir boosted Atazanavir + 2 NRTIs

Intervention Type: DRUG

ATV/RTV 300/100 mg QD + 2 optimized NRTIs for 96 weeks. Treatment should be taken orally with a light meal at the same time each day.

Interventions

Ritonavir boosted Atazanavir + Lamivudine

ATV/RTV 300/100 mg QD + 2 optimized NRTIs for the first 4 weeks and then they will receive ATV/RTV 300/100 mg QD (once daily) and 3TC 300 mg QD for another 92 weeks. Treatment should be taken orally with a light meal at the same time each day.

Intervention Type: DRUG

Ritonavir boosted Atazanavir + 2 NRTIs

ATV/RTV 300/100 mg QD + 2 optimized NRTIs for 96 weeks. Treatment should be taken orally with a light meal at the same time each day.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signature of informed consent
• At least 18 years old
• Patients on their 1st ARV treatment consisting on 2 NRTIs + 1 third agent for at least 1 year
• Undetectable viral load for at least 6 months prior to inclusion in the study (VL<50 c/mL in 2 determinations 6 months apart; blips are not allowed).
• Requirement of ARV treatment change due to toxicity, intolerance or simplification.
• Clinically stable.

Exclusion Criteria

• Pregnant women or women who plan to get pregnant during the study.
• Breast feeding
• History of change of any ARV treatment component for any reason 4 months prior to the inclusion in the trial
• History of ARV treatment change due to virological failure
• History of confirmed virological failure defined as one single VL >400 c/mL or at least 2 VL between 50 and 400 c/mL one year after an indetectable VL was achieved.
• Absence of HIV genotype prior to ARV treatment initiation.
• Resistance mutation to any of the study drugs (ATV, RTV, 3TC)
• HBV infection.
• History of toxicity or intolerance to ATV, RTV or 3TC.
• Gilbert's syndrome.
• Use of contraindicated drugs.
• Lab abnormalities grade 4.

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

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Fundacion SEIMC-GESIDA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José A Pérez-Molina, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramon y Cajal

Locations

Hospital de Elche

Elche, Alicante, Spain

Hospital Marina Baixa

Villajoyosa, Alicante, Spain

H. Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital General de Granollers

Granollers, Barcelona, Spain

Hospital de Jerez

Jerez de la Frontera, Cádiz, Spain

H. Juan Ramón Jiménez

Huelva, Huelva, Spain

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, La Coruña, Spain

H. San Pedro

Logroño, La Rioja, Spain

Hospital Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

Hospital Severo Ochoa

Leganés, Madrid, Spain

H. Clinico San Carlos

Madrid, Madrid, Spain

H. Universitario Infanta Leonor

Madrid, Madrid, Spain

H. Universitario Son Espases

Mallorca, Mallorca, Spain

Hospital Costa del Sol

Marbella, Málaga, Spain

Hospital Arquitecto Marcide

Ferrol, Pontevedra, Spain

Hospital Xeral Cíes

Vigo, Pontevedra, Spain

H. Universitario Central de Asturias

Asturias, Principality of Asturias, Spain

Hospital de Basurto

Basurto, Vizcaya, Spain

Hospital Juan Canalejo

A Coruña, , Spain

Hospital General de Alicante

Alicante, , Spain

Hospital Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Vall d'Hebrón

Barcelona, , Spain

Hospital Reina Sofía

Córdoba, , Spain

Hospital Clínico San Cecilio

Granada, , Spain

Hospital Virgen de las Nieves

Granada, , Spain

Hospital Doce de Octubre

Madrid, , Spain

Hospital Gregorio Marañón

Madrid, , Spain

Hospital La Paz

Madrid, , Spain

Hospital Ramón y Cajal

Madrid, , Spain

Hospital de Mataró

Mataró, , Spain

Hospital Virgen de la Victoria

Málaga, , Spain

Hospital de Navarra

Pamplona, , Spain

Hospital Donostia

San Sebastián, , Spain

Hospital Marqués de Valdecilla

Santander, , Spain

Hospital de Santa Tecla

Tarragona, , Spain

Hospital La Fe

Valencia, , Spain

Countries

Spain

References

Perez-Molina JA, Rubio R, Rivero A, Pasquau J, Suarez-Lozano I, Riera M, Estebanez M, Santos J, Sanz-Moreno J, Troya J, Marino A, Antela A, Navarro J, Esteban H, Moreno S; GESIDA 7011 Study Group. Dual treatment with atazanavir-ritonavir plus lamivudine versus triple treatment with atazanavir-ritonavir plus two nucleos(t)ides in virologically stable patients with HIV-1 (SALT): 48 week results from a randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2015 Jul;15(7):775-84. doi: 10.1016/S1473-3099(15)00097-3. Epub 2015 Jun 7.

Reference Type: DERIVED

PMID: 26062881 (View on PubMed)

Other Identifiers

2011-001107-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GESIDA 7011

Identifier Type: -

Identifier Source: org_study_id