Table 1.
Characteristics of mothers who received the study drug and their infants
| Characteristic of mothers or infantsd | Value (range) for: |
||
|---|---|---|---|
| Group 1a | Group 2b | Group 3c | |
| Mothers | |||
| Median age (yr) | 23.5 (19–44) | 27.5 (19–37) | 26 (22–37) |
| Race (no.) | |||
| Black | 11 | 6 | 5 |
| Hispanic | 3 | 2 | 2 |
| White | 0 | 0 | 2 |
| Median viral load (log10 copies/ml) | 1.83 (1.70–3.95) | 1.70 (1.70–3.17)e | 1.70 (1.70–2.32) |
| Median wt (kg) | 87.5 (65.3–124.7) | 82.8 (67.1–113.5) | 90.7 (45–111.3) |
| Median time from dose to delivery (h) | 5.4 (0.3–35.7) | 7 (1.6–12)e | 7.3 (4.7–70.1) |
| No. who delivered vaginally | 6 | 5 | 5 |
| No. who received background ART that was: | |||
| PI based | 4 | 6 | 8 |
| NNRTI based | 2 | ||
| NRTI based | 7 | 2 | 1 |
| Other | 1 | ||
| Infants | |||
| Median birth wt (kg) | 3.1 (2.4–4.2) | 3.4 (2.8–4.1)e | 3.2 (2.8–3.7) |
| Median gestational age (wk) | 40 (38–42) | 40 (38–42)e | 39 (37–41) |
| Median time from birth to study drug dose (h) | Not applicable | 6 (4–7.9) | 4.7 (1.8–11) |
a
Group 1 consisted of mothers (n = 14) given 600 mg TDF.
b
Group 2 consisted of mothers (n = 8) given 900 mg TDF and infants (n = 8) given 4 mg/kg TDF.
c
Group 3 consisted of mothers (n = 9) given 900 mg TDF and 600 mg FTC and infants (n = 9) given 4 mg/kg TDF and 3 mg/kg FTC.
d
PI, protease inhibitor; NNRTI, nonnucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor. All NNRTI-based regimens contained nevirapine. All NRTI-based regimens consisted of zidovudine, lamivudine, and abacavir. The “other” ART regimen contained efavirenz and lopinavir-ritonavir.
e
n = 7.