Background:The purpose of our study was to assess the effects on infants of protease inhibitor (PI)-based antiretroviral therapy (ART) given to their HIV-positive mothers during pregnancy.Material/Methods:A multicenter observational study was carried out at 11 centers in Spain, involving 124 HIV-1-infected pregnant women under ART and their infants. The mothers were classified according to the ART protocols used during pregnancy into two groups: group A, 52 women with >2 nucleoside reverse transcriptase inhibitors (NRTI) with or without NNRTI, for a mean time of 4.7±2.2 months; and group B, 72 women on protease inhibitor (PI)-based regimens for 5.4±2.6 months.Conclusions:Optimal management of HIV-1 infection in women, regardless of their pregnancy status, can be recommended in more developed countries, without adverse effects on pregnancy outcome, and dramatically decreasing vertical transmission. HAART with PI versus potent ART during pregnancy was effective and safe for infants throughout the 12-month follow-up. In the light of recent advances in anti-HIV-1 pregnancy therapy, the long-term safety of these prophylactic and therapeutical strategies should be studied.

Keywords: Anti-HIV Agents - therapeutic use, Anti-Retroviral Agents - therapeutic use, Disease Transmission, Vertical, HIV Infections, HIV Seropositivity, HIV-1 - metabolism, Infant, Newborn, Pregnancy, Pregnancy Complications, Infectious, Pregnancy Outcome, Reverse Transcriptase Inhibitors - therapeutic use, Spain, Time Factors, Anti-HIV Agents - therapeutic use, Anti-Retroviral Agents - therapeutic use, HIV Infections, HIV Seropositivity, HIV-1 - metabolism, Infant, Newborn, Infectious Disease Transmission, Vertical, Pregnancy, Pregnancy Complications, Infectious, Pregnancy Outcome, Reverse Transcriptase Inhibitors - therapeutic use, Spain, Time Factors