GRACE - An open-label, multi-center trial to compare the efficacy, safety and tolerability of Prezista/r by gender and race, when administered in combination with an individually optimized background regimen over a 48 week period.

Eligible candidates:

• Must be HIV-infected individuals aged 18 years or older
• Have HIV viral load over 1000 copies/ml
• Have previous intolerance or failure to prior therapy consisting of a protease inhibitor (PI) and/or non-nucleoside reverse transcriptase inhibitor (NNRTI) based HAART regimen of at least 12 weeks.
• Individuals who have prior use of Prezista, TMC125, T-20 or tipranavir are not eligible for this study.
• Additional requirements will be discussed by the study nurse or doctor.

Study Objective:
This study aims to evaluate any sex differences in the efficacy of Prezista/r plus an optimized background regiment over a 48-week treatment period.

Study Scheme:
The study consists of a total of 10 visits. No blinding will take place in this study, all participants will receive Prezista/r 600/100mg b.i.d. (twice daily) and optimized background regimen.

Study Drugs:

• Prezista/r

Study Status: Closed to enrollment.

Study Staff:

• Judith Aberg, MD
• Margie Vasquez, RN
• Luis Vargas

Study Sponsors:

• Tibotec Therapeutics

Study Volunteers Receive:

• Cost-free lab work
• Transportation reimbursement