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.

NCT00381303 | Completed Phase 3 Results DMC

• 2 other identifiers: CR011869TMC114HIV3004
• Study Type: interventional
• Target: 429
• Locations: 3 countries
• Sites: 46

Brief Summary

The purpose of this study is to evaluate any differences in the effectiveness, safety, and tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day on virologic response (defined as a viral load (VL) of \< 50 copies/mL) over a 48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV) agents will also be administered and will be chosen by the Investigator based on resistance testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).

Conditions

HIV; Infectious

Keywords

HIV; AIDS; Immunodeficiency Virus, Human; Females; Women; PREZISTA; darunavir; TMC114; Protease Inhibitor

Outcome Measures

Primary Outcomes (2)

• Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex

  TLOVR - responders/non-responders per FDA TLOVR response algorithm. A subject was considered a responder at that time point and that subsequent. A subject was considered a non-responder at a time point in the following situations: discontinued treatment at that time point, a rebound value at that time point and that subsequent or at that time point and that followed by treatment discontinuation, intermittent missing values were considered a response if the immediately preceding and following visits were a response, rebound at earlier time point, or any new, unplanned ARV except in tolerability

  Week 48

• Number of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex

  TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.

  Week 48

Secondary Outcomes (8)

• Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race

  Week 48

• Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects

  Week 48

• Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race

  Week 48

• Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA

  Week 48

• Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values

  Baseline, Week 48

Study Arms (1)

001

EXPERIMENTAL

darunavir 600mg bid for 48 wks,ritonavir 100mg bid for 48 wks

Drug: darunavir; Drug: ritonavir

Interventions

darunavir DRUG

600mg bid for 48 wks

001

ritonavir DRUG

100mg bid for 48 wks

001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented HIV infection
• Plasma HIV-RNA \>= 1000 copies/mL
• Must be able to comply with protocol requirements

You may not qualify if:

• No prior use of PREZISTA (darunavir), TMC125, enfuvirtide, or tipranavir
• No currently active AIDS defining illness, Category C conditions according to the Center for Disease Control \[CDC\] Classification System for HIV Infection (1993) with the following exceptions, which must be discussed with the Sponsor prior to enrollment: stable cutaneous Kaposi's Sarcoma, Wasting syndrome due to HIV infection
• Not currently using an investigational drug
• Not pregnant or breastfeeding
• No Grade 3 or 4 laboratory abnormality as defined by DAIDS (Division of AIDS, National Institute of Allergy and Infectious Diseases).

Sponsors & Collaborators

• Tibotec, Inc: lead
• Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA: collaborator

Study Sites (46)

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Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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Torrance, California, United States

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Washington D.C., District of Columbia, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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North Palm Beach, Florida, United States

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Orlando, Florida, United States

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Pensacola, Florida, United States

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Port Saint Lucie, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Savannah, Georgia, United States

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Chicago, Illinois, United States

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Kansas City, Kansas, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Detroit, Michigan, United States

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St Louis, Missouri, United States

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Neptune City, New Jersey, United States

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Newark, New Jersey, United States

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New York, New York, United States

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The Bronx, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Harlingen, Texas, United States

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Houston, Texas, United States

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Longview, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Hamilton, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Ponce, PR, Puerto Rico

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Rio Piedras, Puerto Rico

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Related Publications (3)

• Tsoukas C, Gilbert L, Lewis T, Hatzakis G, Falcon R, Mrus J. Improvements in Immune Function and Activation with 48-Week Darunavir/Ritonavir-Based Therapy: GRACE Substudy. ISRN AIDS. 2013 Dec 12;2013:358294. doi: 10.1155/2013/358294. eCollection 2013.

  PMID: 24396625 DERIVED

• Smith KY, Garcia F, Kumar P, Currier JS, Ryan R, Falcon R, Mrus J, Squires K. Assessing darunavir/ritonavir-based therapy in a racially diverse population: 48-week outcomes from GRACE. J Natl Med Assoc. 2012 Jul-Aug;104(7-8):366-76. doi: 10.1016/s0027-9684(15)30179-6.

  PMID: 23092052 DERIVED

• 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. doi: 10.7326/0003-4819-153-6-201009210-00002.

  PMID: 20855799 DERIVED

MeSH Terms

Conditions

Communicable Diseases; Acquired Immunodeficiency Syndrome

Interventions

Darunavir; Ritonavir

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles

Results Point of Contact

• Title: Vice President, Tibotec Therapeutics Clinical Affairs
• Organization: Tibotec Therapeutics Clinical Affairs (TTCA), Division of Centocor Ortho Biotech Services, LLC

877-732-2488

Study Officials

• Tibotec, Inc. Clinical Trial

  Tibotec, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 27, 2006
• Study Start: November 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 21, 2014
• Results First Posted: October 19, 2010

Record last verified: 2014-04

Locations

PR (2); US (41); CA (3)