Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression
This trial is active, not recruiting.
|Sponsor||Ospedale San Raffaele|
|Start date||September 2010|
|End date||July 2013|
|Trial size||117 participants|
|Trial identifier||NCT01511809, MODAt|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
time frame: week 48
Efficacy and Safety
time frame: week 96
Male or female participants from 18 years up to 90 years old.
- HIV infected patients
- age > 18 years
- On treatment with ATV/r plus 2 NRTIs for at least 48 weeks
- Virological suppression (HIV-RNA<50 c/ml) by at least 24 weeks with ATV/r plus 2 NRTIs
- No virologic failure after the initiation of the first antiretroviral therapy. Previous treatment changes due to toxicity or treatment simplifications will be permitted only if occurred with documented virological suppression.
- CD4 cells nadir >100 cells/µL
- PPI and H2-receptor antagonists as follows: the proton-pump inhibitors should not be used; if H2-receptor antagonists are co-administered, a dose equivalent to famotidine 20 mg BID should not be exceeded.
- Pregnancy and breast feeding women
- AIDS defining events
- Evidence of active HBV infection (HBsAg positive)
- Previous virological failure
- History of resistance to ATV
- Use of contraindicated medications
|Official title||Efficacy of Atazanavir / Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression. Randomized, Open Label Non Inferiority Trial. A Phase 3 Study.|
|Principal investigator||Adriano Lazzarin, Professor|
|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.|
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