This trial is active, not recruiting.

Condition hiv-1 infection
Treatment atazanavir/ritonavir monotherapy
Phase phase 3
Sponsor Ospedale San Raffaele
Collaborator Bristol-Myers Squibb
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy
atazanavir/ritonavir monotherapy
Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks.
(No Intervention)
Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone

Primary Outcomes

time frame: week 48

Secondary Outcomes

Efficacy and Safety
time frame: week 96

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Ospedale San Raffaele.