Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy

HIV Infection Clinical Trial

— SALT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307488
• Other study ID #: GESIDA 7011
• Secondary ID: 2011-001107-12
• Status: Completed
• Phase: Phase 4
• First received: March 1, 2011
• Last updated: May 8, 2015
• Start date: September 2011
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Fundacion SEIMC-GESIDA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: March 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• HIV Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Príncipe de Asturias	Alcalá de Henares	Madrid
Spain	Hospital General de Alicante	Alicante
Spain	H. Universitario Central de Asturias	Asturias
Spain	H. Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Hospital Vall d'Hebrón	Barcelona
Spain	Hospital de Basurto	Basurto	Vizcaya
Spain	Hospital Reina Sofía	Córdoba
Spain	Hospital Arquitecto Marcide	El Ferrol	Pontevedra
Spain	Hospital de Elche	Elche	Alicante
Spain	Hospital Clínico San Cecilio	Granada
Spain	Hospital Virgen de las Nieves	Granada
Spain	Hospital General de Granollers	Granollers	Barcelona
Spain	H. Juan Ramón Jiménez	Huelva
Spain	Hospital de Jerez	Jerez de la Frontera	Cádiz
Spain	Hospital Juan Canalejo	La Coruña
Spain	Hospital Severo Ochoa	Leganés	Madrid
Spain	H. San Pedro	Logroño	La Rioja
Spain	H. Clinico San Carlos	Madrid
Spain	H. Universitario Infanta Leonor	Madrid
Spain	Hospital Doce de Octubre	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Virgen de la Victoria	Málaga
Spain	H. Universitario Son Espases	Mallorca
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Hospital de Mataró	Mataró
Spain	Hospital de Navarra	Pamplona
Spain	Hospital Donostia	San Sebastián
Spain	Hospital Marqués de Valdecilla	Santander
Spain	Complexo Hospitalario Universitario de Santiago	Santiago de Compostela	La Coruña
Spain	Hospital de Santa Tecla	Tarragona
Spain	Hospital La Fe	Valencia
Spain	Hospital Xeral Cíes	Vigo	Pontevedra
Spain	Hospital Marina Baixa	Villajoyosa	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion SEIMC-GESIDA	Bristol-Myers Squibb

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs	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	Week 48	No
Secondary	To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs	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	week 24	No
Secondary	To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs	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	week 96	No
Secondary	To assess safety after 24 weeks fo treatment	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.	Week 24	Yes
Secondary	To assess safety after 48 weeks fo treatment	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.	Week 48	Yes
Secondary	To assess safety after 96 weeks fo treatment	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.	Week 96	Yes
Secondary	To assess the incidence of resistance, and characterization of this resistance following a virological rebound	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)	Week 96	Yes
Secondary	To assess neurocognitive function evolution	Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 48	Week 48	No
Secondary	To assess neurocognitive function evolution	Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 96	Week 96	No