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.

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)).

Timeline

Start

2006-11

Primary completion

2008-11

Completion

2008-12

Publications

• 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.
• 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.
• 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.

Drugs

Indications