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.
Drug: Atazanavir, ritonavir, lamivudine
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Locations near you
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Full eligibility criteria for NCT01599364
Ages eligible for Study
18 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT01599364
Ospedale S. M. Annunziata - U.O. Malattie Infettive
Bagno a Ripoli, Firenze, Italy, 50011
P.O. "S. Caterina Novella" - UOC di Malattie Infettive
Galatina, Lecce, Italy, 73013
Azienda Ospedaliero Universitaria - Ospedali Riuniti di Ancona Struttura Organizzativa Dipartimentale (S.O.D) Clinica di Malattie infettive
Ancona, Italy, 60126
Brescia, Italy, 25123
Azienda Ospedaliera di Rilievo Nazionale di alta specializzazione Garibaldi di Catania - Istituto Malattie infettive
Catania, Italy, 95122
Azienda Ospedaliera Universitaria San Martino - Clinica Malattie Infettive
Genova, Italy, 16132
A.O. Ospedale Niguarda Cà Granda - Malattie Infettive
Milano, Italy, 20126
Ospedale San Raffaele
Milano, Italy, 20127
Ospedale Luigi Sacco di Milano - Malattie infettive I Divisione
Milano, Italy, 20157
Ospedale Luigi Sacco di Milano Azienda ospedaliera e Polo Universitario - Dip. di Scienze Cliniche L. Sacco / Sez. Malattie Infettive
Milano, Italy, 20157
A.O. Universitaria Policlinico Paolo Giaccone di Palermo - Malattie Infettive
Palermo, Italy, 9127
Ospedale S. Maria della Misericordia
Perugia, Italy, 06129
IRCCS Istituto Dermatologico S. Gallicano (IFO) - UOC Dermatologia Infettiva
Roma, Italy, 00144
I.N.M.I. L. Spallanzani I.R.C.C.S. - .O.C. Malattie Infettive e Tropicali IV Divisione
Roma, Italy, 00149
I.N.M.I. L. Spallanzani I.R.C.C.S. - U.O.C. Infezioni Sistemiche e dell'Immunodepresso II Divisione
Roma, Italy, 00149
Università' degli studi di Roma La Sapienza - Dipartimento di Malattie Infettive e Tropicali
Roma, Italy, 00161
Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Università degli studi di Sassari - Reparto Malattie Infettive
Sassari, Italy, 07100
Dipartimento di Malattie Infettive
Torino, Italy, 10149
Azienda ULSS 9 Treviso Ospedale S. Maria di Ca'Foncello - U.O. Malattie infettive
Treviso, Italy, 31100
Azienda Ospedaliera Universitaria Integrata di Verona - U.O.C. Malattie infettive
Verona, Italy, 37134
View full eligibility
Tris trial is registered with FDA with number: NCT01599364. The sponsor of the trial is Catholic University of the Sacred Heart and it is looking for 266 volunteers for the current phase.
Official trial title: Safety and Efficacy of Switching a Stable Combined Antiretroviral Therapeutic Regimen to Atazanavir With Ritonavir Plus Lamivudine in Treatment Experienced HIV Positive Patients With Full and Stable Virological Suppression
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