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.

Study NCT00381303 Information provided by Tibotec, Inc

First Received on September 26, 2006. Last Updated on January 13, 2011 History of Changes

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 Infections Infection
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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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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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.

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 ]

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2. Primary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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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 ]

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10. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If TTCA does not publish within 12 months after study conclusion or after TTCA confirms there will be no multicenter publication, Institution may publish their results from their site individually, provided TTCA has 60 day review for confidentiality and additional 60 day delay for patent application.

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
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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:

Currier J, Averitt Bridge D, Hagins D, Zorrilla CD, Feinberg J, Ryan R, Falcon R, Tennenberg A, Mrus J, Squires K; GRACE (Gender, Race, And Clinical Experience) Study Group. Sex-based outcomes of darunavir-ritonavir therapy: a single-group trial. Ann Intern Med. 2010 Sep 21;153(6):349-57.

Responsible Party:	Vice President, 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:	January 13, 2011
Health Authority:	United States: Food and Drug Administration