We evaluated the safety and efficacy of a twice daily regimen containing 400 mg of indinavir and 100 mg of ritonavir in 32 human immunodeficiency virus (HIV)-infected women during pregnancy. The median indinavir trough concentration was 208 ng/ml during the third trimester. At delivery, 26 of 28 women on indinavirritonavir had HIV RNA levels of <200 copies/ml. No infant was HIV infected. These data are encouraging for the use of this combination for prevention of mother-to-child transmission of HIV.Protease inhibitor (PI)-based combinations are the current standard of care for human immunodeficiency virus type 1 (HIV-1)-infected pregnant women in France (18). Published data describing indinavir (IDV) pharmacokinetic parameters for pregnant women are limited and suggest that IDV plasma concentrations may be suboptimal in pregnant women taking standard doses of IDV (7; D. Wara, R. Tuomala, and Y. Bryson, presented at the 2nd Conference on Global Strategies for the Prevention of HIV Transmission from Mothers to Infants, Montreal, Canada, 1999). Thus, use of unboosted IDV should be avoided during pregnancy (12, 15). We have previously shown the good efficacy and tolerability of a twice daily (BID) regimen containing 400 mg of IDV and 100 mg of ritonavir (hereafter referred to as IDV/r 400/100 mg BID) in patients switching from a standard IDV-containing regimen (6) and in patients initiating a first-line treatment (4). The objective of this study was to describe, in terms of effects on mothers and newborns, the safety and tolerability of and responses to an IDV/r 400/100 mg BID regimen during the antenatal period in HIV-1-infected pregnant women.In a prospective, observational, pilot, open-label, single-center, noncomparative study, the efficacy and tolerability of a triple combination of two nucleoside reverse transcriptase inhibitors and IDV/r 400/100 mg BID were evaluated for consecutive HIV-1-infected women in whom pregnancy was diagnosed before the third trimester. The patients were followed monthly with clinical examinations and biological assessments, including plasma HIV RNA (lower limit of quantification [LOQ], 200 copies/ml; Amplicor HIV monitor kit; Roche, Meylan, France) and CD4 cell counts. Steady-state IDV plasma trough concentrations (C trough values) were determined during the third trimester by high-performance liquid chromatography coupled with UV detection (LOQ, 5 ng/ml) (17). IDV C trough was determined during the month following delivery for a subset of women. The expected efficient IDV C trough was 120 ng/ml (1).The mode of delivery was determined according to plasma viral load (VL), obstetrical history, and personal decision. All women received intravenous zidovudine (ZDV) infusions initiated during labor or 2 h before elective caesarean section, and newborns received a 6-week course of ZDV (0.2 mg/kg of body weight four times a day), as recommended by French guidelines (18). All women received counseling on the risk of HIV-1 transmission through breastfeeding, and no woman reported breastfeedi...