Phase 3
Completed N=429
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.
HIV · Infectious
Source: ClinicalTrials.gov NCT00381303 ↗
Enrolled (actual)
429
Serious AEs
18.7%
Results posted
Oct 2010
Primary outcomePrimary: Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex — 146; 83 participants — p=0.30
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)).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex |
146; 83 | 0.30 |
| PRIMARY Number of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex |
146; 83 | — |
| SECONDARY Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race |
128; 39; 59; 2; 1 | — |
| SECONDARY Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects |
69; 54; 74; 21; 25; 2 | — |
| SECONDARY Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race |
128; 39; 59; 2; 1 | — |
| SECONDARY Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA |
69; 54; 74; 21; 25; 2 | — |
| SECONDARY Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values |
152; 122; 143; 151; 133; 45 | — |
| SECONDARY Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values |
136; 108; 135; 111; 98; 45 | — |
| SECONDARY Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF) |
112; 103; 109; 110; 109; 45 | — |
| SECONDARY Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF |
107; 98; 113; 84; 90; 45 | — |
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT00381303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.