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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier:
NCT01307488
First received: March 1, 2011
Last updated: September 11, 2013
Last verified: September 2013

March 1, 2011
September 11, 2013
September 2011
February 2014   (final data collection date for primary outcome measure)
To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01307488 on ClinicalTrials.gov Archive Site
  • To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 48
  • To assess neurocognitive function evolution [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 96
  • To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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)
Not Provided
Not Provided
 
Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy
Efficacy of Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy in Patients With Viral Suppression. Randomized, Open-label 96 Weeks Non-inferiority Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
325
February 2014
February 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01307488
GESIDA 7011, 2011-001107-12
Yes
Fundacion SEIMC-GESIDA
Fundacion SEIMC-GESIDA
Bristol-Myers Squibb
Principal Investigator: José A Pérez-Molina, MD Hospital Universitario Ramon y Cajal
Fundacion SEIMC-GESIDA
September 2013

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