Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy
- Conditions
- HIV Infection
- Interventions
- Registration Number
- NCT01307488
- Lead Sponsor
- Fundacion SEIMC-GESIDA
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 286
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ATV/r+3TC Ritonavir boosted Atazanavir + Lamivudine Subjects will receive 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/r+2 NRTIs Ritonavir boosted Atazanavir + 2 NRTIs Subjects will receive 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.
- Primary Outcome Measures
Name Time Method To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs Week 48 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
- Secondary Outcome Measures
Name Time Method To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs week 96 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
To assess safety after 24 weeks fo treatment Week 24 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.To assess safety after 48 weeks fo treatment Week 48 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.To assess safety after 96 weeks fo treatment Week 96 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.To assess the incidence of resistance, and characterization of this resistance following a virological rebound Week 96 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)
To assess neurocognitive function evolution Week 96 Nerocognitive function evolution measured through a battery of standardized tests from baseline to week 96
Related Research Topics
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Trial Locations
- Locations (36)
Hospital de Elche
🇪🇸Elche, Alicante, Spain
Hospital Marina Baixa
🇪🇸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
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
Hospital Costa del Sol
🇪🇸Marbella, Málaga, Spain
Scroll for more (26 remaining)Hospital de Elche🇪🇸Elche, Alicante, Spain