GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.

This study has been completed.
Sponsor:
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by (Responsible Party):
Tibotec, Inc
ClinicalTrials.gov Identifier:
NCT00381303
First received: September 26, 2006
Last updated: April 2, 2014
Last verified: April 2014
Results First Received: November 24, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV
Infectious
Interventions: Drug: darunavir
Drug: ritonavir

  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
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
Female darunavir 600 milligram (mg) twice daily dosing (bid) for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
Male darunavir 600 mg twice bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.

Participant Flow:   Overall Study
    Female     Male  
STARTED     287     142  
COMPLETED     193     109  
NOT COMPLETED     94     33  
Lost to Follow-up                 25                 9  
AE/HIV-related event                 22                 6  
Non-Adherence                 13                 6  
Withdrawal by Subject                 13                 6  
Virologic failure                 6                 4  
Ineligible to continue the trial                 2                 1  
Pregnancy                 2                 0  
Physician Decision                 1                 0  
Physician's decision to close the site                 3                 1  
Subject moved out of state                 2                 0  
Subject taking too many different meds                 1                 0  
No virologic response by week 12                 1                 0  
Subject was too busy for appointments                 1                 0  
Subject did not continue visits                 1                 0  
Subject primary physician's decision                 1                 0  



  Baseline Characteristics
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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
Female darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
Male darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
Total Total of all reporting groups

Baseline Measures
    Female     Male     Total  
Number of Participants  
[units: participants]
  287     142     429  
Age  
[units: years]
Median ( Full Range )
  43  
  ( 19 to 78 )  
  45  
  ( 21 to 78 )  
  43  
  ( 19 to 78 )  
Gender  
[units: participants]
     
Female     287     0     287  
Male     0     142     142  
Race/Ethnicity, Customized  
[units: participants]
     
Black     191     73     264  
Caucasian/White     34     31     65  
Hispanic     60     36     96  
Asian     0     2     2  
Other     2     0     2  
Previous Antiretroviral (ARV) Experience: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)  
[units: participants]
     
NNRTI: < 1 drug count     83     32     115  
NNRTI: >= 1 drug count     204     110     314  
Previous ARV experience: Protease inhibitor (PI)  
[units: participants]
     
PI: <2     119     50     169  
PI: >=2     168     92     260  
CD4+ cell count  
[units: cells/L]
Median ( Full Range )
  210  
  ( 1 to 868 )  
  175  
  ( 2 to 1125 )  
  200  
  ( 1 to 1125 )  
Plasma log10 copies/mL VL HIV-1 RNA  
[units: copies/mL]
Mean ± Standard Deviation
  4.65  ± 0.883     4.73  ± 0.856     4.67  ± 0.874  
Time since HIV-infection diagnosis  
[units: years]
Median ( Full Range )
  10.78  
  ( 0.29 to 27.62 )  
  11.91  
  ( 1.21 to 23.76 )  
  11.3  
  ( 0.29 to 27.62 )  



  Outcome Measures
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1.  Primary:   Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex   [ Time Frame: Week 48 ]

2.  Primary:   Number of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex   [ Time Frame: Week 48 ]

3.  Secondary:   Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race   [ Time Frame: Week 48 ]

4.  Secondary:   Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects   [ Time Frame: Week 48 ]

5.  Secondary:   Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race   [ Time Frame: Week 48 ]

6.  Secondary:   Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA   [ Time Frame: Week 48 ]

7.  Secondary:   Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values   [ Time Frame: Baseline, Week 48 ]

8.  Secondary:   Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values   [ Time Frame: Week 48 ]

9.  Secondary:   Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF)   [ Time Frame: Week 48 ]

10.  Secondary:   Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF   [ Time Frame: Week 48 ]


  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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Tibotec Therapeutics Clinical Affairs
Organization: Tibotec Therapeutics Clinical Affairs (TTCA), Division of Centocor Ortho Biotech Services, LLC
phone: 877-732-2488


No publications provided by Tibotec, Inc

Publications automatically indexed to this study:

Responsible Party: Tibotec, Inc
ClinicalTrials.gov Identifier: NCT00381303     History of Changes
Other Study ID Numbers: CR011869, TMC114HIV3004
Study First Received: September 26, 2006
Results First Received: November 24, 2009
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration