Maternal toxicity and pregnancy complications in human immunodeficiency virus-infected women receiving antiretroviral therapy: PACTG 316.
OBJECTIVE
The purpose of this study was to evaluate rates of maternal toxicity, pregnancy complications, and peripartum morbidity by type and duration of antiretroviral therapy (ART) during pregnancy.


METHODS
The Pediatric AIDS Clinical Trials Group (PACTG) Protocol 316 (PACTG 316) study evaluated the addition of intrapartum/neonatal nevirapine to background ART to reduce perinatal transmission of human immunodeficiency virus-1 (HIV-1). For this secondary analysis, women were categorized into one of six groups on the basis of ART during pregnancy (monotherapy [monoRx], combination without protease inhibitor [PI], combination with PI), and start time (early: before or during first trimester; late: second or third trimester).


RESULTS
One thousand four hundred seven women were included: 288 monoRx late, 34 monoRx early, 327 combo, no PI late, 175 combo, no PI early, 320 combo, PI late, and 263 combo, PI early. Symptoms and laboratory abnormalities of moderate grade or more occurred in less than 5% of women. Only gestational diabetes (highest in combo PI early) varied significantly by therapy group.


CONCLUSIONS
In HIV-infected women receiving prenatal care and ART, adverse events were uncommon.
National Institute of Child Health and Human Development, Bethesda, MD 20892, USA. hw59I@nih.gov
D Heather
DH
Watts
Rajalakshmi
R
Balasubramanian
Robert T
RT
Maupin
Isaac
I
Delke
Alejandro
A
Dorenbaum
Simone
S
Fiore
Marie-Louise
ML
Newell
Jean-Francois
JF
Delfraissy
Richard D
RD
Gelber
Lynne M
LM
Mofenson
Mary
M
Culnane
Coleen K
CK
Cunningham
D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use; D044966:Anti-Retroviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015897:Comorbidity; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology; D017320:HIV Protease Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D006760:Hospitalization; D006801:Humans; D019829:Nevirapine / Q000009:adverse effects / Q000627:therapeutic use; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy* / Q000453:epidemiology; D011256:Pregnancy Outcome; D016032:Randomized Controlled Trials as Topic
D019380:Anti-HIV Agents; D044966:Anti-Retroviral Agents; D017320:HIV Protease Inhibitors; D019829:Nevirapine