Clinical trial
GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA…
NCT00381303 · Tibotec, Inc, Industry · Completed
Key facts
| NCT number | NCT00381303 |
|---|---|
| Title | 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. |
| Official title | GRACE: An Open-label, Multicenter Trial to Compare the Efficacy, Safety, and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race, When Administered in Combination With an Individually Optimized Background Regimen Over a 48-week Treatment Period. |
| Lead sponsor | Tibotec, Inc, Industry |
| Collaborators | Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | HIV, Infectious |
| Intervention type | Drug |
| Interventions | darunavir, ritonavir |
| Enrollment | 429 |
| Start date | Nov 1, 2006 |
| Primary completion | Nov 1, 2008 |
| Completion | Dec 1, 2008 |
| First posted | Sep 27, 2006 |
| Last update posted | Apr 21, 2014 |
| Countries | Canada, Puerto Rico, United States |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: