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A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00524368
First received: August 30, 2007
Last updated: February 12, 2013
Last verified: February 2013
Results First Received: August 27, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus - Type 1
Interventions: Drug: Darunavir (DRV)
Drug: Ritonavir (rtv)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
One hundred thirteen investigators in 21 countries participated in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total 1092 participants were screened, of which 590 participants were randomly assigned and treated (294 participants were treated with DRV/rtv 800/100 mg once daily, and 296 participants with DRV/rtv 600/100 mg twice daily.

Reporting Groups
  Description
DRV/Rtv 800/100 mg Once Daily Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
DRV/Rtv 600/100 mg Twice Daily One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily

Participant Flow:   Overall Study
    DRV/Rtv 800/100 mg Once Daily     DRV/Rtv 600/100 mg Twice Daily  
STARTED     294     296  
COMPLETED     253     248  
NOT COMPLETED     41     48  
Adverse Event                 10                 12  
Lost to Follow-up                 9                 13  
Withdrawal by Subject                 4                 5  
Non-compliant                 8                 9  
Reached a Virologic Endpoint                 3                 2  
Sponsor's Decision                 2                 0  
Ineligible to Continue the study                 2                 5  
Unspecified                 3                 2  



  Baseline Characteristics


  Outcome Measures
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1.  Primary:   Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm   [ Time Frame: 48 Weeks ]

2.  Secondary:   Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL)   [ Time Frame: 48 weeks ]

3.  Secondary:   Change in log10 Viral Load From Baseline at Week 48   [ Time Frame: 48 weeks ]

4.  Secondary:   Time to Reach First Virologic Response   [ Time Frame: 48 weeks ]

5.  Secondary:   Time to Loss of Virologic Response   [ Time Frame: 48 weeks ]

6.  Secondary:   Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks   [ Time Frame: 48 weeks ]

7.  Secondary:   Change in CD4+ Cell Count From Baseline   [ Time Frame: 48 Weeks ]

8.  Secondary:   Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score   [ Time Frame: 48 weeks ]

9.  Secondary:   Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48   [ Time Frame: 48 weeks ]

10.  Secondary:   Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv   [ Time Frame: 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48. ]

11.  Secondary:   Predose Plasma Concentration (C0h) of DRV and Rtv.   [ Time Frame: 0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48 ]

12.  Secondary:   Number of Participants Developing Mutations at Endpoint   [ Time Frame: 48 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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