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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Castagna Antonella, Ospedale San Raffaele
ClinicalTrials.gov Identifier:
NCT01511809
First received: January 13, 2012
Last updated: November 7, 2013
Last verified: November 2013

January 13, 2012
November 7, 2013
September 2010
July 2013   (final data collection date for primary outcome measure)
HIV-RNA [ Time Frame: week 48 ] [ Designated as safety issue: No ]
Proportion of patients with confirmed virological failure (two consecutive measurements of HIV-RNA> 50 copies/ml)at week 48 in the two study arms.
Same as current
Complete list of historical versions of study NCT01511809 on ClinicalTrials.gov Archive Site
Efficacy and Safety [ Time Frame: week 96 ] [ Designated as safety issue: Yes ]

Proportion of pts with confirmed virological and treatment failure at w96. Change in CD4 cell counts.

Occurrence of viral resistance to atazanavir in pts with confirmed virologic failure.

Proportion of pts with adverse events, with ≥grade 2 adverse events or abnormal laboratory tests, proportion of pts with side effects leading to discontinuation.

Body fat redistribution and vertebral and femoral bone mineral density. Adherence changes; changes in HIV-associated neurocognitive disorders. Difference in levels of activated Tcells and pro-inflammatory cytokines between treatment groups.

Same as current
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1 Infection
Drug: Atazanavir/ritonavir monotherapy
Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks.
  • Experimental: Atazanavir/ritonavir monotherapy
    Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy
    Intervention: Drug: Atazanavir/ritonavir monotherapy
  • No Intervention: Atazanavir/ritonavir 300mg/100mg OD plus 2 NRTIs
    Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
117
December 2015
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01511809
MODAt
Yes
Castagna Antonella, Ospedale San Raffaele
Ospedale San Raffaele
Bristol-Myers Squibb
Principal Investigator: Adriano Lazzarin, Professor Ospedale San Raffaele
Ospedale San Raffaele
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP