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.
Public ClinicalTrials.gov record NCT00381303. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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)).
Study identification
- NCT ID
- NCT00381303
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 429 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2006 (Type not available)
- Primary completion
- Nov 2008 (Actual)
- Completion
- Dec 2008 (Actual)
- Last update posted
- Apr 21, 2014
2006 – 2008
United States locations
- U.S. sites
- 41
- U.S. states
- 21
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Sacramento | California | — | — |
| Not listed | Torrance | California | — | — |
| Not listed | Washington D.C. | District of Columbia | — | — |
| Not listed | Fort Lauderdale | Florida | — | — |
| Not listed | Jacksonville | Florida | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | North Palm Beach | Florida | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | Pensacola | Florida | — | — |
| Not listed | Port Saint Lucie | Florida | — | — |
| Not listed | West Palm Beach | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Savannah | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Kansas City | Kansas | — | — |
| Not listed | New Orleans | Louisiana | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Springfield | Massachusetts | — | — |
| Not listed | Detroit | Michigan | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Neptune City | New Jersey | — | — |
| Not listed | Newark | New Jersey | — | — |
| Not listed | New York | New York | — | — |
| Not listed | The Bronx | New York | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Durham | North Carolina | — | — |
| Not listed | Winston-Salem | North Carolina | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Austin | Texas | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Harlingen | Texas | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Longview | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Charlottesville | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00381303, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 21, 2014 · Synced Oct 31, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00381303 live on ClinicalTrials.gov.