Status:
COMPLETED
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.
Lead Sponsor:
Tibotec, Inc
Collaborating Sponsors:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Conditions:
HIV
Infectious
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 vir...
Detailed Description
This is a multi-center, open-label (doctors and patients know which drug is being administered), Phase IIIb clinical trial to evaluate differences in effectiveness, safety, and tolerability of darunav...
Eligibility Criteria
Inclusion
- Documented HIV infection
- Plasma HIV-RNA \>= 1000 copies/mL
- Must be able to comply with protocol requirements
Exclusion
- 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).
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
429 Patients enrolled
Trial Details
Trial ID
NCT00381303
Start Date
November 1 2006
End Date
December 1 2008
Last Update
April 21 2014
Active Locations (46)
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1
Birmingham, Alabama, United States
2
Phoenix, Arizona, United States
3
Los Angeles, California, United States
4
Sacramento, California, United States