Clinical Study

Pharmacokinetics and Pharmacodynamics of Darunavir and Etravirine in HIV-1–Infected, Treatment-Experienced Patients in the Gender, Race, and Clinical Experience (GRACE) Trial

Table 1

Baseline demographics and disease characteristics for the pharmacokinetic population (overall and etravirine populations).

ParameterOverall
Etravirine
subgroup

Sex, n (%)
 Male128 (34.0)82 (43.2)
 Female248 (66.0)108 (56.8)
Race, n (%)
 Black226 (60.1)122 (64.2)
 Hispanic84 (22.3)33 (17.4)
 White62 (16.5)31 (16.3)
 Asian/other4 (1.1)4 (2.1)
Median (range) age, years43.0 (19.0, 78.0)45.0 (19.0, 78.0)
Mean (SE) weight, kg76.7 (1.03)76.8 (1.50)
Mean (SE) BMI, kg/m2 27.0 (0.50)
Mean (SE) duration of HIV infection, years 12.5
Mean (SE) HIV-1 RNA, log10 copies/mL4.64 (0.044)4.60 (0.067)
Median (range) count, cells/mm3203 (2, 1125)186 (1, 1125)
CDC Class C, n (%)148 (39.4)87 (45.8)
Median (range) darunavir, fold chang 0.6 (0.3, 607.9)
Median (range) etravirine, fold chang 1.4 (0.3, 93.8)
Prior use of ≥2 PIs, n (%)228 (60.6)135 (71.1)

. cvirco®TYPE HIV-1 resistance analysis; patients were considered susceptible to darunavir if the fold change was <3.4 and to etravirine if the fold change was <3.2. ; 2 patients, one Hispanic and one white (both women), did not have resistance testing at baseline. SE: standard error; BMI: body mass index; CDC: United States Center for Disease Control and Prevention; PI: protease inhibitor.