NCT01599364

Brief Summary

The purpose of this study is to evaluate the virological efficacy of maintenance therapy with atazanavir with ritonavir combined with lamivudine in treatment experienced HIV positive patients with full and stable virological suppression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_4

Geographic Reach
1 country

21 active sites

Status
completed

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

May 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2012

Completed
1.9 years until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2018

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

May 14, 2012

Last Update Submit

July 23, 2019

Conditions

Human Immunodeficiency Virus

Keywords

HIV infectionAtazanavirLamivudineRitonavirvirological suppressionnon-inferiorityCombined antiretroviral therapy

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with viral load < 50 copies/mL

    Proportion of patients with viral load \< 50 copies/mL at week 48 at the intention-to-treat with switch = failure analysis

    at week 48

Secondary Outcomes (1)

  • Efficacy and the safety of atazanavir with ritonavir combined with lamivudine in treatment experienced HIV positive patients with full and stable virological suppression

    48 and 96 weeks

Study Arms (2)

Switch

EXPERIMENTAL

Switch to Atazanavir 300 mg with ritonavir 100 mg plus lamivudine 300 mg

Drug: Atazanavir, ritonavir, lamivudine

continue

NO INTERVENTION

Continue Atazanavir 300 mg with ritonavir 100 mg with the same NRTI backbone

Interventions

Atazanavir, ritonavir, lamivudineDRUG

Lamivudine 300 mg 1 pill once-a-day, atazanavir 300 mg 1 pill with ritonavir 100 mg 1 pill once-a-day, taken together orally with a light meal

Also known as: Lamivudine (Epivir, GSK), Atazanavir (Reyataz, BMS), Ritonavir (Norvir, Abbott)
Switch

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV positive patients 18 years of age or older who signed an informed consent form
  • Already on cART, without any treatment interruption.
  • Treated with a cART regimen containing atazanavir boosted with ritonavir since at least 3 months
  • With full virological suppression (VL\<50 copies/mL) for a minimum of six months and in at least in two consecutive determination 3 months +/-2 weeks apart from each other
  • With CD4 cell count \>200 since at least 6 months and without opportunistic infections or other AIDS-related events since at least one year before screening

You may not qualify if:

  • Previous virological failure on a lamivudine- or PI-containing regimen or previous exposure to lamivudine-containing suboptimal antiretroviral regimens
  • Patients with at least a single viral load blip over 200 copies/mL
  • Patients with M184V or major atazanavir resistance mutation at previous genotypic resistance test (historical genotype)
  • Pregnancy or lactation, planned pregnancy in the short-term
  • Patients with HBsAg positive chronic HBV infection
  • Patients who experienced major toxicities related to any of the study drugs in the past
  • Patients with grade 4 laboratory abnormalities at baseline (excluding lipid profile and plasma bilirubin concentration).
  • Patients with non-AIDS related illnesses which could, in the Clinician's judgement, jeopardize the patient's compliance to the study procedures (i.e. Child-Pugh B or higher liver cirrhosis, active cancers on treatment…).
  • Patients treated with proton-pump inhibitors or other concomitant medication with potential for interactions reducing exposure to atazanavir

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Ospedale S. M. Annunziata - U.O. Malattie Infettive

Bagno a Ripoli, Firenze, 50011, Italy

Location

P.O. "S. Caterina Novella" - UOC di Malattie Infettive

Galatina, Lecce, 73013, Italy

Location

Azienda Ospedaliero Universitaria - Ospedali Riuniti di Ancona Struttura Organizzativa Dipartimentale (S.O.D) Clinica di Malattie infettive

Ancona, 60126, Italy

Location

Azienda Ospedaliera Spedali Civili - Istituto di Malattie Infettive e Tropicali

Brescia, 25123, Italy

Location

Azienda Ospedaliera di Rilievo Nazionale di alta specializzazione Garibaldi di Catania - Istituto Malattie infettive

Catania, 95122, Italy

Location

Azienda Ospedaliera Universitaria San Martino - Clinica Malattie Infettive

Genova, 16132, Italy

Location

A.O. Ospedale Niguarda Cà Granda - Malattie Infettive

Milan, 20126, Italy

Location

Ospedale San Raffaele

Milan, 20127, Italy

Location

Ospedale Luigi Sacco di Milano - Malattie infettive I Divisione

Milan, 20157, Italy

Location

Ospedale Luigi Sacco di Milano Azienda ospedaliera e Polo Universitario - Dip. di Scienze Cliniche L. Sacco / Sez. Malattie Infettive

Milan, 20157, Italy

Location

A.O. Universitaria Policlinico Paolo Giaccone di Palermo - Malattie Infettive

Palermo, 9127, Italy

Location

Ospedale S. Maria della Misericordia

Perugia, 06129, Italy

Location

IRCCS Istituto Dermatologico S. Gallicano (IFO) - UOC Dermatologia Infettiva

Roma, 00144, Italy

Location

I.N.M.I. L. Spallanzani I.R.C.C.S. - .O.C. Malattie Infettive e Tropicali IV Divisione

Roma, 00149, Italy

Location

I.N.M.I. L. Spallanzani I.R.C.C.S. - U.O.C. Infezioni Sistemiche e dell'Immunodepresso II Divisione

Roma, 00149, Italy

Location

Università' degli studi di Roma La Sapienza - Dipartimento di Malattie Infettive e Tropicali

Roma, 00161, Italy

Location

Università Cattolica del S. Cuore Policlinico Universitario A. Gemelli - Istituto di Clinica delle Malattie Infettive

Roma, 00168, Italy

Location

Università degli studi di Sassari - Reparto Malattie Infettive

Sassari, 07100, Italy

Location

Ospedale Amedeo di Savoia - Divisione A Malattie Infettive

Torino, 10149, Italy

Location

Azienda ULSS 9 Treviso Ospedale S. Maria di Ca'Foncello - U.O. Malattie infettive

Treviso, 31100, Italy

Location

Azienda Ospedaliera Universitaria Integrata di Verona - U.O.C. Malattie infettive

Verona, 37134, Italy

Location

Related Publications (2)

  • Fabbiani M, Gagliardini R, Ciccarelli N, Quiros Roldan E, Latini A, d'Ettorre G, Antinori A, Castagna A, Orofino G, Francisci D, Chinello P, Madeddu G, Grima P, Rusconi S, Del Pin B, Lombardi F, D'Avino A, Foca E, Colafigli M, Cauda R, Di Giambenedetto S, De Luca A; ATLAS-M Study Group. Atazanavir/ritonavir with lamivudine as maintenance therapy in virologically suppressed HIV-infected patients: 96 week outcomes of a randomized trial. J Antimicrob Chemother. 2018 Jul 1;73(7):1955-1964. doi: 10.1093/jac/dky123.

    PMID: 29668978DERIVED

  • Di Giambenedetto S, Fabbiani M, Quiros Roldan E, Latini A, D'Ettorre G, Antinori A, Castagna A, Orofino G, Francisci D, Chinello P, Madeddu G, Grima P, Rusconi S, Di Pietro M, Mondi A, Ciccarelli N, Borghetti A, Foca E, Colafigli M, De Luca A, Cauda R; Atlas-M Study Group. Treatment simplification to atazanavir/ritonavir + lamivudine versus maintenance of atazanavir/ritonavir + two NRTIs in virologically suppressed HIV-1-infected patients: 48 week results from a randomized trial (ATLAS-M). J Antimicrob Chemother. 2017 Apr 1;72(4):1163-1171. doi: 10.1093/jac/dkw557.

    PMID: 28093483DERIVED

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV Infections

Interventions

Atazanavir SulfateRitonavirLamivudinehalofantrine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsThiazolesSulfur CompoundsOrganic ChemicalsAzolesZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Study Officials

  • Mauro MM Moroni, MD

    Università di Milano Direttore clinica Malattie infettive

    STUDY CHAIR

  • Pierluigi PZ Zoccolotti, MD

    Università di Roma La Sapienza Dipartimento di Psicologia

    STUDY CHAIR

  • Stafano SV Vella, MD

    Dipartimento del farmaco all'Istituto Superiore della Sanità

    STUDY CHAIR

  • Roberto RC Cauda, MD

    Università Cattolica del S. Cuore Policlinico Universitario A. Gemelli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 14, 2012

First Posted

May 16, 2012

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

February 23, 2018

Last Updated

July 24, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(21)