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 17, 2014
Last verified: November 2014
Results First Received: November 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-1 Infection
Intervention: Drug: Atazanavir/ritonavir monotherapy

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Atazanavir/Ritonavir Monotherapy

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.

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

Participant Flow:   Overall Study
    Atazanavir/Ritonavir Monotherapy     Atazanavir/Ritonavir Triple Therapy  
STARTED     58     59  
COMPLETED     51     52  
NOT COMPLETED     7     7  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Atazanavir/Ritonavir Monotherapy

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.

Atazanavir/Ritonavir Triple Therapy Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
Total Total of all reporting groups

Baseline Measures
    Atazanavir/Ritonavir Monotherapy     Atazanavir/Ritonavir Triple Therapy     Total  
Number of Participants  
[units: participants]
  51     52     103  
Age  
[units: years]
Median (Inter-Quartile Range)
  41.4    (35.4 to 47.7)     41.7    (36.6 to 49.8)     41.5    (35.6 to 48)  
Gender  
[units: participants]
     
Female     9     7     16  
Male     42     45     87  
Region of Enrollment  
[units: participants]
     
Italy     51     52     103  
nadir CD4+ [1]
[units: cells/mm3]
Median (Inter-Quartile Range)
  274    (221 to 355)     278    (183 to 364)     276    (211 to 361)  
Years of antiretroviral treatment  
[units: years]
Median (Inter-Quartile Range)
  25    (16 to 47)     25    (18 to 54)     25    (17 to 53)  
HIV-1 RNA <50 copies/ml [2]
[units: months]
Median (Inter-Quartile Range)
  20    (10 to 49)     18    (12 to 49)     19    (11 to 49)  
HIV-RNA at ARV start  
[units: copies/mL]
Median (Inter-Quartile Range)
  79399    (31046 to 183613)     42630    (9696 to 123700)     59062    (10834 to 165850)  
CD4+  
[units: cells/mm3]
Median (Inter-Quartile Range)
  599    (457 to 774)     570    (417 to 735)     575    (432 to 744)  
HCV coinfection  
[units: participants]
     
Present     11     10     21  
Absent     40     42     82  
[1] Lowest CD4+ value among those recorded since the first HIV positive test up to the start of MODAt study
[2] Quantitative value of HIV-1 RNA copies/ml in plasma. HIV-1 RNA below 50 copies/ml (detection limit) is an indicator of efficacy of the antiretroviral therapy



  Outcome Measures

1.  Primary:   Proportion of Patients With Treatment Failure (TF)   [ Time Frame: Up to week 48 ]

2.  Secondary:   Efficacy and Safety   [ Time Frame: week 96 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Antonella Castagna
Organization: Ospedale San Raffaele
phone: 00390226437934
e-mail: castagna.antonella1@hsr.it


Publications:


Responsible Party: Castagna Antonella, Ospedale San Raffaele
ClinicalTrials.gov Identifier: NCT01511809     History of Changes
Other Study ID Numbers: MODAt
Study First Received: January 13, 2012
Results First Received: November 7, 2014
Last Updated: November 17, 2014
Health Authority: Italy: Ethics Committee