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.

Completed · Phase 3

Conditions studied: HIV, Infectious

In brief

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)).

Key facts

Study ID

NCT00381303

Run by

Tibotec, Inc

People needed

429

Starts

2006-11-01

Expected to finish

2008-12-01

Last updated by the study team

2014-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Sacramento, California, United States
• Study site — Torrance, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — North Palm Beach, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Port Saint Lucie, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Kansas City, Kansas, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Neptune City, New Jersey, United States

Full record on ClinicalTrials.gov

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