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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
286
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.
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.
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
Time frame: Week 48
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
Time frame: week 24
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
Time frame: week 96
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.
Time frame: Week 24
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.
Time frame: Week 48
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Hospital de Elche
Elche, Alicante, Spain
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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
H. Juan Ramón Jiménez
Huelva, Huelva, 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
...and 26 more locations
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.
Time frame: Week 96
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)
Time frame: Week 96
To assess neurocognitive function evolution
Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 48
Time frame: Week 48
To assess neurocognitive function evolution
Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 96
Time frame: Week 96