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

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ClinicalTrials.gov Identifier: NCT01307488
Recruitment Status : Completed
First Posted : March 3, 2011
Last Update Posted : May 12, 2015
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA

Tracking Information
First Submitted Date  ICMJE March 1, 2011
First Posted Date  ICMJE March 3, 2011
Last Update Posted Date May 12, 2015
Study Start Date  ICMJE September 2011
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2011)
To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs [ Time Frame: Week 48 ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01307488 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2011)
  • To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs [ Time Frame: week 24 ]
    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 [ Time Frame: week 96 ]
    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 [ Time Frame: Week 24 ]
    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 [ Time Frame: Week 48 ]
    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 [ Time Frame: Week 96 ]
    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 [ Time Frame: Week 96 ]
    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 [ Time Frame: Week 48 ]
    Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 48
  • To assess neurocognitive function evolution [ Time Frame: Week 96 ]
    Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 96
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2011)
  • To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs [ Time Frame: week 24 ]
    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 [ Time Frame: week 96 ]
    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 [ Time Frame: Week 24 ]
    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 [ Time Frame: Week 48 ]
    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 [ Time Frame: Week 96 ]
    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 [ Time Frame: Week 96 ]
    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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy
Official Title  ICMJE Efficacy of Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy in Patients With Viral Suppression. Randomized, Open-label 96 Weeks Non-inferiority Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infection
Intervention  ICMJE
  • Drug: 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.
  • 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Ritonavir boosted Atazanavir + Lamivudine
  • Active Comparator: 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.
    Intervention: Drug: Ritonavir boosted Atazanavir + 2 NRTIs
Publications * Perez-Molina JA, Rubio R, Rivero A, Pasquau J, Suárez-Lozano I, Riera M, Estébanez M, Santos J, Sanz-Moreno J, Troya J, Mariño 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2014)
286
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2011)
392
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01307488
Other Study ID Numbers  ICMJE GESIDA 7011
2011-001107-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundacion SEIMC-GESIDA
Study Sponsor  ICMJE Fundacion SEIMC-GESIDA
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: José A Pérez-Molina, MD Hospital Universitario Ramon y Cajal
PRS Account Fundacion SEIMC-GESIDA
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP