PMID- 22306587
OWN - NLM
STAT- MEDLINE
DCOM- 20120329
LR  - 20191112
IS  - 1528-4336 (Print)
IS  - 1528-4336 (Linking)
VI  - 13
IP  - 1
DP  - 2012 Jan-Feb
TI  - Safety and pharmacokinetics of nelfinavir during the second and third trimesters 
      of pregnancy and postpartum.
PG  - 46-59
LID - 10.1310/hct1301-046 [doi]
AB  - PURPOSE: Evaluate the safety, tolerability, and pharmacokinetics (PK) of 
      nelfinavir during pregnancy and postpartum in HIV-infected women. METHODS: Phase 
      IV, non-randomized, open-label study of nelfinavir 625 mg tablets (1250 mg) in 
      combination with lamivudine/zidovudine twice daily. Primary endpoint was 
      treatment-related or possibly treatment-related gastrointestinal or hepatic 
      adverse events (AEs). Selected maternal and infant outcomes were recorded. 
      Frequent plasma samples were collected for PK studies during the 2nd and 3rd 
      trimesters, and 6 weeks postpartum, to analyze total and free nelfinavir and M8 
      concentrations. RESULTS: Sixteen HIV+ pregnant women were enrolled. Six mild 
      treatment-related AEs and 3 serious AEs occurred; 1 serious AE (elevated AST) met 
      the primary endpoint. Compared with 6 weeks postpartum, levels of total 
      nelfinavir were reduced by 44% and 46%, total M8 by 82% and 83%, free nelfinavir 
      by 48% and 39%, and free M8 by 83% and 79% in the 2nd and 3rd trimesters, 
      respectively. At 6 weeks postpartum, 75% and 50% of subjects maintained HIV-1 RNA 
      levels <400 and <50 copies/mL, respectively. All pregnancies resulted in live 
      births without transmission in 15 infants. CONCLUSIONS: Nelfinavir in combination 
      with lamivudine/zidovudine was generally well tolerated. Total and free 
      nelfinavir and M8 exposure were reduced in late pregnancy.
FAU - Fang, A
AU  - Fang A
AD  - Pfizer Inc, New York, New York 10017, USA.
FAU - Valluri, S R
AU  - Valluri SR
FAU - O'Sullivan, M-J
AU  - O'Sullivan MJ
FAU - Maupin, R
AU  - Maupin R
FAU - Jones, T
AU  - Jones T
FAU - Delke, I
AU  - Delke I
FAU - Clax, P
AU  - Clax P
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - HIV Clin Trials
JT  - HIV clinical trials
JID - 100936377
RN  - 0 (HIV Protease Inhibitors)
RN  - 0 (RNA, Viral)
RN  - HO3OGH5D7I (Nelfinavir)
SB  - IM
MH  - Adult
MH  - CD4 Lymphocyte Count
MH  - Female
MH  - HIV Infections/*drug therapy
MH  - HIV Protease Inhibitors/*adverse effects
MH  - HIV-1/genetics/isolation & purification
MH  - Humans
MH  - Nelfinavir/*adverse effects/pharmacokinetics
MH  - Postpartum Period
MH  - Pregnancy
MH  - Pregnancy Complications, Infectious/*drug therapy
MH  - Pregnancy Trimester, Second
MH  - Pregnancy Trimester, Third
MH  - RNA, Viral/blood
EDAT- 2012/02/07 06:00
MHDA- 2012/03/30 06:00
CRDT- 2012/02/07 06:00
PHST- 2012/02/07 06:00 [entrez]
PHST- 2012/02/07 06:00 [pubmed]
PHST- 2012/03/30 06:00 [medline]
AID - M4882V765P620211 [pii]
AID - 10.1310/hct1301-046 [doi]
PST - ppublish
SO  - HIV Clin Trials. 2012 Jan-Feb;13(1):46-59. doi: 10.1310/hct1301-046.