Table 1.
Patient Demographic Characteristics
| Characteristic | Cohort 1 (n=18) | Cohort 2 (n=22a) |
|---|---|---|
| Mean age yr (range) | 43 (26–63) | 40 (26–54) |
| Gender n (%) | ||
| Male | 14 (78) | 21 (95) |
| Female | 4 (22) | 1 (5) |
| Race n (%) | ||
| Caucasian | 9 (50) | 13 (59) |
| Black | 6 (33) | 4 (18) |
| Asian | 0 | 3 (14) |
| Other | 3 (17) | 2 (9) |
| Body mass index kg/m2 | ||
| Mean (range) | 25.6 (19.3–34.3) | 25.0 (20.4–29.6) |
| CD4 count in cells/μL | ||
| Mean (SD) | 663 (258) | 577 (175) |
| (range) | (261–1000) | (317–907) |
a
Includes the four subjects who were incorrectly dosed with famotidine.
Cohort 1: atazanavir/ritonavir 300/100 mg once daily with 2 or more NRTIs (without TDF) dosed simultaneously with famotidine twice daily (treatments A, B, and C).
Cohort 2: atazanavir/ritonavir/TDF 300/100/300 mg once daily with 1 or more additional NRTI(s) dosed temporally separated from famotidine BID (treatments D, E, and F).
NRTI(s), nucleoside reverse transcriptase inhibitor(s); TDF, tenofovir disoproxil fumurate; SD, standard deviation.