Clinical trial NCT01307488: Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection
Keywords: HIV
AIDS
Atazanavir
Simplification
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2011-03-03
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs
timeFrame: Week 48
Secondary outcomes:
measure: To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs
timeFrame: week 24
measure: To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs
timeFrame: week 96
measure: To assess safety after 24 weeks fo treatment
timeFrame: Week 24
measure: To assess safety after 48 weeks fo treatment
timeFrame: Week 48
measure: To assess safety after 96 weeks fo treatment
timeFrame: Week 96
measure: To assess the incidence of resistance, and characterization of this resistance following a virological rebound
timeFrame: Week 96
measure: To assess neurocognitive function evolution
timeFrame: Week 48
measure: To assess neurocognitive function evolution
timeFrame: Week 96
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital de Elche
state: Alicante
city: Villajoyosa
country: Spain
facility: Hospital Marina Baixa
state: Alicante
city: Badalona
country: Spain
facility: H. Germans Trias i Pujol
state: Barcelona
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: Barcelona
city: Jerez de la Frontera
country: Spain
facility: Hospital de Jerez
state: Cádiz
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario de Santiago
state: La Coruña
city: Logroño
country: Spain
facility: H. San Pedro
state: La Rioja
city: Alcalá de Henares
country: Spain
facility: Hospital Príncipe de Asturias
state: Madrid
city: Leganés
country: Spain
facility: Hospital Severo Ochoa
state: Madrid
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: El Ferrol
country: Spain
facility: Hospital Arquitecto Marcide
state: Pontevedra
city: Vigo
country: Spain
facility: Hospital Xeral Cíes
state: Pontevedra
city: Basurto
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Asturias
country: Spain
facility: H. Universitario Central de Asturias
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebrón
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Granada
country: Spain
facility: Hospital Clínico San Cecilio
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Huelva
country: Spain
facility: H. Juan Ramón Jiménez
city: La Coruña
country: Spain
facility: Hospital Juan Canalejo
city: Madrid
country: Spain
facility: H. Clinico San Carlos
city: Madrid
country: Spain
facility: H. Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Mallorca
country: Spain
facility: H. Universitario Son Espases
city: Mataró
country: Spain
facility: Hospital de Mataró
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Pamplona
country: Spain
facility: Hospital de Navarra
city: San Sebastián
country: Spain
facility: Hospital Donostia
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
city: Tarragona
country: Spain
facility: Hospital de Santa Tecla
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
affiliation: Hospital Universitario Ramon y Cajal
name: José A Pérez-Molina, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perez-Molina JA, Rubio R, Rivero A, Pasquau J, Suarez-Lozano I, Riera M, Estebanez M, Santos J, Sanz-Moreno J, Troya J, Marino 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.