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.

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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)).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tibotec, Inc
• Collaborator: Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
• Treatments: Darunavir; Ritonavir

Criteria

Inclusion Criteria:

• Documented HIV infection

• Plasma HIV-RNA >= 1000 copies/mL

• Must be able to comply with protocol requirements

Exclusion Criteria:

• 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).