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Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy (SALT)

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Ritonavir boosted Atazanavir + Lamivudine
Ritonavir boosted Atazanavir + 2 NRTIs
Sponsored by
Fundacion SEIMC-GESIDA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV, AIDS, Atazanavir, Simplification

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Elche
  • Hospital Marina Baixa
  • H. Germans Trias i Pujol
  • Hospital General de Granollers
  • Hospital de Jerez
  • Complexo Hospitalario Universitario de Santiago
  • H. San Pedro
  • Hospital Príncipe de Asturias
  • Hospital Severo Ochoa
  • Hospital Costa del Sol
  • Hospital Arquitecto Marcide
  • Hospital Xeral Cíes
  • Hospital de Basurto
  • Hospital General de Alicante
  • H. Universitario Central de Asturias
  • Hospital Santa Creu i Sant Pau
  • Hospital Vall d'Hebrón
  • Hospital Reina Sofía
  • Hospital Clínico San Cecilio
  • Hospital Virgen de las Nieves
  • H. Juan Ramón Jiménez
  • Hospital Juan Canalejo
  • H. Clinico San Carlos
  • H. Universitario Infanta Leonor
  • Hospital Doce de Octubre
  • Hospital Gregorio Marañón
  • Hospital La Paz
  • Hospital Ramón y Cajal
  • H. Universitario Son Espases
  • Hospital de Mataró
  • Hospital Virgen de la Victoria
  • Hospital de Navarra
  • Hospital Donostia
  • Hospital Marqués de Valdecilla
  • Hospital de Santa Tecla
  • Hospital La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ATV/r+3TC

ATV/r+2 NRTIs

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 24 weeks of treatment
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 96 weeks of treatment
To assess safety after 24 weeks fo treatment
Frequency of adverse events, SAEs, AEs leading to discontinuations, death and laboratory abnormalities. Describe renal function, plasma Vitamin D and bone density changes (DEXA) from baseline and particularly in those patients receiving TDF at screening.
To assess safety after 48 weeks fo treatment
Frequency of adverse events, SAEs, AEs leading to discontinuations, death and laboratory abnormalities. Describe renal function, plasma Vitamin D and bone density changes (DEXA) from baseline and particularly in those patients receiving TDF at screening.
To assess safety after 96 weeks fo treatment
Frequency of adverse events, SAEs, AEs leading to discontinuations, death and laboratory abnormalities. Describe renal function, plasma Vitamin D and bone density changes (DEXA) from baseline and particularly in those patients receiving TDF at screening.
To assess the incidence of resistance, and characterization of this resistance following a virological rebound
Genotypic antiretroviral resistance profiles of subjects experiencing virologic failure (genotype) Plasma samples at Baseline and at each visit will be stored for additional resistance studies (i.e. cDNA)
To assess neurocognitive function evolution
Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 48
To assess neurocognitive function evolution
Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 96

Full Information

First Posted
March 1, 2011
Last Updated
May 8, 2015
Sponsor
Fundacion SEIMC-GESIDA
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01307488
Brief Title
Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy
Acronym
SALT
Official Title
Efficacy of Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy in Patients With Viral Suppression. Randomized, Open-label 96 Weeks Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion SEIMC-GESIDA
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV, AIDS, Atazanavir, Simplification

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ATV/r+3TC
Arm Type
Experimental
Arm Description
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.
Arm Title
ATV/r+2 NRTIs
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ritonavir boosted Atazanavir + Lamivudine
Intervention Description
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
Intervention Name(s)
Ritonavir boosted Atazanavir + 2 NRTIs
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs
Description
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
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs
Description
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 24 weeks of treatment
Time Frame
week 24
Title
To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs
Description
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 96 weeks of treatment
Time Frame
week 96
Title
To assess safety after 24 weeks fo treatment
Description
Frequency of adverse events, SAEs, AEs leading to discontinuations, death and laboratory abnormalities. Describe renal function, plasma Vitamin D and bone density changes (DEXA) from baseline and particularly in those patients receiving TDF at screening.
Time Frame
Week 24
Title
To assess safety after 48 weeks fo treatment
Description
Frequency of adverse events, SAEs, AEs leading to discontinuations, death and laboratory abnormalities. Describe renal function, plasma Vitamin D and bone density changes (DEXA) from baseline and particularly in those patients receiving TDF at screening.
Time Frame
Week 48
Title
To assess safety after 96 weeks fo treatment
Description
Frequency of adverse events, SAEs, AEs leading to discontinuations, death and laboratory abnormalities. Describe renal function, plasma Vitamin D and bone density changes (DEXA) from baseline and particularly in those patients receiving TDF at screening.
Time Frame
Week 96
Title
To assess the incidence of resistance, and characterization of this resistance following a virological rebound
Description
Genotypic antiretroviral resistance profiles of subjects experiencing virologic failure (genotype) Plasma samples at Baseline and at each visit will be stored for additional resistance studies (i.e. cDNA)
Time Frame
Week 96
Title
To assess neurocognitive function evolution
Description
Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 48
Time Frame
Week 48
Title
To assess neurocognitive function evolution
Description
Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 96
Time Frame
Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José A Pérez-Molina, MD
Organizational Affiliation
Hospital Universitario Ramon y Cajal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Elche
City
Elche
State/Province
Alicante
Country
Spain
Facility Name
Hospital Marina Baixa
City
Villajoyosa
State/Province
Alicante
Country
Spain
Facility Name
H. Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
Country
Spain
Facility Name
Hospital General de Granollers
City
Granollers
State/Province
Barcelona
Country
Spain
Facility Name
Hospital de Jerez
City
Jerez de la Frontera
State/Province
Cádiz
Country
Spain
Facility Name
Complexo Hospitalario Universitario de Santiago
City
Santiago de Compostela
State/Province
La Coruña
Country
Spain
Facility Name
H. San Pedro
City
Logroño
State/Province
La Rioja
Country
Spain
Facility Name
Hospital Príncipe de Asturias
City
Alcalá de Henares
State/Province
Madrid
Country
Spain
Facility Name
Hospital Severo Ochoa
City
Leganés
State/Province
Madrid
Country
Spain
Facility Name
Hospital Costa del Sol
City
Marbella
State/Province
Málaga
Country
Spain
Facility Name
Hospital Arquitecto Marcide
City
El Ferrol
State/Province
Pontevedra
Country
Spain
Facility Name
Hospital Xeral Cíes
City
Vigo
State/Province
Pontevedra
Country
Spain
Facility Name
Hospital de Basurto
City
Basurto
State/Province
Vizcaya
Country
Spain
Facility Name
Hospital General de Alicante
City
Alicante
Country
Spain
Facility Name
H. Universitario Central de Asturias
City
Asturias
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Vall d'Hebrón
City
Barcelona
Country
Spain
Facility Name
Hospital Reina Sofía
City
Córdoba
Country
Spain
Facility Name
Hospital Clínico San Cecilio
City
Granada
Country
Spain
Facility Name
Hospital Virgen de las Nieves
City
Granada
Country
Spain
Facility Name
H. Juan Ramón Jiménez
City
Huelva
Country
Spain
Facility Name
Hospital Juan Canalejo
City
La Coruña
Country
Spain
Facility Name
H. Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
H. Universitario Infanta Leonor
City
Madrid
Country
Spain
Facility Name
Hospital Doce de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Gregorio Marañón
City
Madrid
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
H. Universitario Son Espases
City
Mallorca
Country
Spain
Facility Name
Hospital de Mataró
City
Mataró
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Málaga
Country
Spain
Facility Name
Hospital de Navarra
City
Pamplona
Country
Spain
Facility Name
Hospital Donostia
City
San Sebastián
Country
Spain
Facility Name
Hospital Marqués de Valdecilla
City
Santander
Country
Spain
Facility Name
Hospital de Santa Tecla
City
Tarragona
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26062881
Citation
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.
Results Reference
derived

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Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy

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