Trial record 5 of 33 for:    " February 09, 2011":" March 11, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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.


Condition Intervention Phase
HIV Infection
Drug: Ritonavir boosted Atazanavir + Lamivudine
Drug: Ritonavir boosted Atazanavir + 2 NRTIs
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fundacion SEIMC-GESIDA:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 325
Study Start Date: September 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307488

Locations
Spain
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
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
Hospital Costa del Sol
Marbella, Málaga, Spain
Hospital Arquitecto Marcide
El Ferrol, Pontevedra, Spain
Hospital Xeral Cíes
Vigo, Pontevedra, Spain
Hospital de Basurto
Basurto, Vizcaya, Spain
Hospital General de Alicante
Alicante, Spain
H. Universitario Central de Asturias
Asturias, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Spain
Hospital Vall d'Hebrón
Barcelona, Spain
Hospital Reina Sofía
Córdoba, Spain
Hospital Virgen de las Nieves
Granada, Spain
Hospital Clínico San Cecilio
Granada, Spain
H. Juan Ramón Jiménez
Huelva, Spain
Hospital Juan Canalejo
La Coruña, Spain
Hospital Doce de Octubre
Madrid, Spain
H. Universitario Infanta Leonor
Madrid, Spain
H. Clinico San Carlos
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain
H. Universitario Son Espases
Mallorca, 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
Sponsors and Collaborators
Fundacion SEIMC-GESIDA
Bristol-Myers Squibb
Investigators
Principal Investigator: José A Pérez-Molina, MD Hospital Universitario Ramon y Cajal
  More Information

No publications provided

Responsible Party: Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier: NCT01307488     History of Changes
Other Study ID Numbers: GESIDA 7011, 2011-001107-12
Study First Received: March 1, 2011
Last Updated: September 11, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundacion SEIMC-GESIDA:
HIV
AIDS
Atazanavir
Simplification

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lamivudine
Ritonavir
Atazanavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014