NCT01511809

Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression

Efficacy of Atazanavir / Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression. Randomized, Open Label Non Inferiority Trial. A Phase 3 Study.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The study will assess whether Atazanavir/ritonavir monotherapy provides a non-inferior proportion of virological efficacy with respect to ATV/RTV + 2 NRTIs in patients with stable suppressed viremia and no prior virologic failures.

Detailed description

This is a randomised (1:1), multicentre, comparative, parallel-group, prospective, open label, non-inferiority controlled clinical trial. Enrolled patients, taking an ATV/r based HAART and with stable HIV-RNA \< 50c/ml (24 weeks), will be randomized to: * continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs (according to the specific dosing schedule) as backbone (HAART arm) with ATV/r * or simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy (Monotherapy arm) with ATV/r The study follow up will be 96 weeks after randomization and primary objective will be evaluated at week 48. Patients will be followed every 4 weeks for the first 16 weeks, and then every 8 weeks until week 48, then every 12 weeks until week 96 or discontinuation ; at each visit the following evaluations will be performed: * clinical assessment. * routine laboratory tests (hematological tests and hematochemistry) including creatinine, phosphorus, calcium, alkaline phosphatase, gammaGT; urine analysis, lipid profile, level of HIV-RNA and CD4 cell counts. During follow-up, at randomization, week 48, week 96 or discontinuation, patients will additionally undergo: * Fat redistribution evaluation by DEXA (dual-energy X-ray absorptiometry * Vertebral and femoral bone mineral density evaluation by DEXA. * ECG; * Glicate haemoglobin. * Adherence assessment (questionnaire and/or pills counts). * Neurocognitive evaluation \[HIV-associated neurocognitive disorders (HANDs) evaluated by validated neuropsychological tests\]. In case of viral rebound (defined as 2 consecutive measurement of HIV-RNA \> 50 c/ml) patients will be immediately contacted in order to perform genotypic tests. Furthermore a plasma PK analysis will also be performed. Any patients with virological rebound will be selected for a reintensification therapy with NRTIs and if not suppressed after 12 weeks they will be discontinued.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	Atazanavir/ritonavir monotherapy	Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks.

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-07-01
• Completion: 2015-05-01
• First posted: 2012-01-19
• Last updated: 2024-02-09
• Results posted: 2014-11-24

Locations

1 site across 1 country: Italy