NCT01511809

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2010

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 24, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

2.8 years

First QC Date

January 13, 2012

Results QC Date

November 7, 2014

Last Update Submit

February 7, 2024

Conditions

HIV-1 Infection

Keywords

HIV-1

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients With Treatment Failure (TF)

    Proportion of patients with treatment failure defined as having one of the following events: confirmed viral rebound (CVR) or treatment discontinuation for any cause. CVR was established when 2 consecutive viral load values (HIV-1 RNA)\>50 copies/mL occurred within 2 weeks during follow-up. In case of CVR, patients treated with atazanavir/ritonavir monotherapy had to re-introduce their previous 2NRTIs (re-intensification) and, if not suppressed (HIV-1 RNA \<50 copies /ml) after 12 weeks, discontinued from the study. Re-intensification was considered as treatment failure in the primary analysis conducted according to the intention-to-treat principle (intention-to-treat analysis with re-intensification equal failure, ITT=Failure) while it was not in the secondary analysis (intention-to-treat analysis with re-intensification equal success, ITT=Success).

    Up to week 48

Secondary Outcomes (1)

  • Efficacy and Safety

    week 96

Study Arms (2)

Atazanavir/ritonavir monotherapy

EXPERIMENTAL

Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy

Drug: Atazanavir/ritonavir monotherapy

Atazanavir/ritonavir triple therapy

NO INTERVENTION

Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone

Interventions

Atazanavir/ritonavir monotherapyDRUG

Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks.

Also known as: ATV/r monotherapy
Atazanavir/ritonavir monotherapy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infectious Diseases Department Fondazione Centro San Raffaele

Milan, Lombardy, 20127, Italy

Location

Related Publications (10)

  • Delfraissy JF, Flandre P, Delaugerre C, Ghosn J, Horban A, Girard PM, Norton M, Rouzioux C, Taburet AM, Cohen-Codar I, Van PN, Chauvin JP. Lopinavir/ritonavir monotherapy or plus zidovudine and lamivudine in antiretroviral-naive HIV-infected patients. AIDS. 2008 Jan 30;22(3):385-93. doi: 10.1097/QAD.0b013e3282f3f16d.

    PMID: 18195565BACKGROUND

  • Cameron DW, da Silva BA, Arribas JR, Myers RA, Bellos NC, Gilmore N, King MS, Bernstein BM, Brun SC, Hanna GJ. A 96-week comparison of lopinavir-ritonavir combination therapy followed by lopinavir-ritonavir monotherapy versus efavirenz combination therapy. J Infect Dis. 2008 Jul 15;198(2):234-40. doi: 10.1086/589622.

    PMID: 18540803BACKGROUND

  • Pulido F, Arribas JR, Delgado R, Cabrero E, Gonzalez-Garcia J, Perez-Elias MJ, Arranz A, Portilla J, Pasquau J, Iribarren JA, Rubio R, Norton M; OK04 Study Group. Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and two nucleosides for maintenance therapy of HIV. AIDS. 2008 Jan 11;22(2):F1-9. doi: 10.1097/QAD.0b013e3282f4243b.

    PMID: 18097218BACKGROUND

  • Arribas JR, Delgado R, Arranz A, Munoz R, Portilla J, Pasquau J, Perez-Elias MJ, Iribarren JA, Rubio R, Ocampo A, Sanchez-Conde M, Knobel H, Arazo P, Sanz J, Lopez-Aldeguer J, Montes ML, Pulido F; OK04 Study Group. Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and 2 nucleosides for maintenance therapy of HIV: 96-week analysis. J Acquir Immune Defic Syndr. 2009 Jun 1;51(2):147-52. doi: 10.1097/QAI.0b013e3181a56de5.

    PMID: 19349870BACKGROUND

  • Arribas JR, Horban A, Gerstoft J, Fatkenheuer G, Nelson M, Clumeck N, Pulido F, Hill A, van Delft Y, Stark T, Moecklinghoff C. The MONET trial: darunavir/ritonavir with or without nucleoside analogues, for patients with HIV RNA below 50 copies/ml. AIDS. 2010 Jan 16;24(2):223-30. doi: 10.1097/QAD.0b013e3283348944.

    PMID: 20010070BACKGROUND

  • Katlama C, Valantin MA, Algarte-Genin M, Duvivier C, Lambert-Niclot S, Girard PM, Molina JM, Hoen B, Pakianather S, Peytavin G, Marcelin AG, Flandre P. Efficacy of darunavir/ritonavir maintenance monotherapy in patients with HIV-1 viral suppression: a randomized open-label, noninferiority trial, MONOI-ANRS 136. AIDS. 2010 Sep 24;24(15):2365-74. doi: 10.1097/QAD.0b013e32833dec20.

    PMID: 20802297BACKGROUND

  • Swindells S, DiRienzo AG, Wilkin T, Fletcher CV, Margolis DM, Thal GD, Godfrey C, Bastow B, Ray MG, Wang H, Coombs RW, McKinnon J, Mellors JW; AIDS Clinical Trials Group 5201 Study Team. Regimen simplification to atazanavir-ritonavir alone as maintenance antiretroviral therapy after sustained virologic suppression. JAMA. 2006 Aug 16;296(7):806-14. doi: 10.1001/jama.296.7.806.

    PMID: 16905786BACKGROUND

  • Karlstrom O, Josephson F, Sonnerborg A. Early virologic rebound in a pilot trial of ritonavir-boosted atazanavir as maintenance monotherapy. J Acquir Immune Defic Syndr. 2007 Apr 1;44(4):417-22. doi: 10.1097/QAI.0b013e31802e2940.

    PMID: 17159658BACKGROUND

  • Wilkin TJ, McKinnon JE, DiRienzo AG, Mollan K, Fletcher CV, Margolis DM, Bastow B, Thal G, Woodward W, Godfrey C, Wiegand A, Maldarelli F, Palmer S, Coffin JM, Mellors JW, Swindells S. Regimen simplification to atazanavir-ritonavir alone as maintenance antiretroviral therapy: final 48-week clinical and virologic outcomes. J Infect Dis. 2009 Mar 15;199(6):866-71. doi: 10.1086/597119.

    PMID: 19191590BACKGROUND

  • Vernazza P, Daneel S, Schiffer V, Decosterd L, Fierz W, Klimkait T, Hoffmann M, Hirschel B. The role of compartment penetration in PI-monotherapy: the Atazanavir-Ritonavir Monomaintenance (ATARITMO) Trial. AIDS. 2007 Jun 19;21(10):1309-15. doi: 10.1097/QAD.0b013e32814e6b1c.

    PMID: 17545707BACKGROUND

MeSH Terms

Interventions

Atazanavir Sulfate

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Dr. Antonella Castagna
Organization
Ospedale San Raffaele
castagna.antonella1@hsr.it
00390226437934

Study Officials

  • Adriano Lazzarin, Professor

    Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co- Investigator

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 19, 2012

Study Start

September 1, 2010

Primary Completion

July 1, 2013

Study Completion

May 1, 2015

Last Updated

February 9, 2024

Results First Posted

November 24, 2014

Record last verified: 2024-02

Locations

IT(1)