Table 2.
Outcomes Assessed at the Time of Delivery Among Pregnant Study Participants Who Were Randomly Assigned to Receive Efavirenz (EFV)–Based Antiretroviral Therapy (ART) or Lopinavir/Ritonavir (LPV/r)–Based ART
| Outcome | Treatment Arm |
RR (95% CI) | P Value | |
|---|---|---|---|---|
| EFV-based ART | LPV/r-based ART | |||
| Malaria positivity, by test | ||||
| Placental blood smear | 6/158 (3.8) | 5/158 (3.2) | 0.83 (.26–2.67) | .76 |
| Placental blood RDT | 7/155 (4.5) | 6/157 (3.8) | 0.85 (.29–2.46) | .76 |
| Placental blood PCR | 15/153 (9.8) | 11/149 (7.4) | 0.75 (.36–1.59) | .45 |
| Histopathologic analysis | 47/165 (28.5) | 62/162 (38.3) | 1.34 (.98–1.83) | .06 |
| Birth outcome | ||||
| Spontaneous abortion or stillbirth | 7/187 (3.7) | 5/190 (2.6) | 0.70 (.23–2.18) | .54 |
| Neonatal deatha | 4/180 (2.2) | 8/185 (4.3) | 1.95 (.60–6.35) | .26 |
| Preterm delivery | 34/187 (18.2) | 39/190 (20.5) | 1.13 (.75–1.71) | .56 |
| Low birth weight | 33/178 (18.5) | 39/181 (21.5) | 1.16 (.77–1.76) | .48 |
| Composite adverse birth outcome | 50/180 (27.8) | 63/186 (33.9) | 1.22 (.89–1.66) | .21 |
Data are no. of participants with the outcome/no. evaluated (%).
Abbreviations: CI, confidence interval; PCR, polymerase chain reaction; RDT, rapid diagnostic test; RR, relative risk.
a Only including live births.