Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy
SALT
Efficacy of Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy in Patients With Viral Suppression. Randomized, Open-label 96 Weeks Non-inferiority Trial
2 other identifiers
interventional
286
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2011
Longer than P75 for phase_4
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
March 3, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMay 12, 2015
May 1, 2015
2.6 years
March 1, 2011
May 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs
Non-inferiority will be considered when the difference in proportion of efficacy between experimental arm (ATV/RTV + 3TC) vs. control arm (ATV/RTV + 2 optimized NRTIs) arm is less or equal to -0.12% after 48 weeks of treatment
Week 48
Secondary Outcomes (8)
To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs
week 24
To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs
week 96
To assess safety after 24 weeks fo treatment
Week 24
To assess safety after 48 weeks fo treatment
Week 48
To assess safety after 96 weeks fo treatment
Week 96
- +3 more secondary outcomes
Study Arms (2)
ATV/r+3TC
EXPERIMENTALSubjects 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.
ATV/r+2 NRTIs
ACTIVE COMPARATORSubjects 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.
Interventions
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/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.
Eligibility Criteria
You may qualify if:
- 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
- Requirement of ARV treatment change due to toxicity, intolerance or simplification.
- Clinically stable.
You may not qualify if:
- Pregnant women or women who plan to get pregnant during the study.
- Breast feeding
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundacion SEIMC-GESIDAlead
- Bristol-Myers Squibbcollaborator
Study Sites (36)
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
Related Publications (1)
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. Erratum In: Lancet Infect Dis. 2015 Sep;15(9):998. doi: 10.1016/S1473-3099(15)00241-8.
PMID: 26062881DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José A Pérez-Molina, MD
Hospital Universitario Ramon y Cajal
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2011
First Posted
March 3, 2011
Study Start
September 1, 2011
Primary Completion
April 1, 2014
Study Completion
March 1, 2015
Last Updated
May 12, 2015
Record last verified: 2015-05