PMID- 11131706
OWN - NLM
STAT- MEDLINE
DCOM- 20010111
LR  - 20190616
IS  - 0077-8923 (Print)
IS  - 0077-8923 (Linking)
VI  - 918
DP  - 2000 Nov
TI  - Evaluating the safety of interventions for prevention of perinatal transmission 
      of HIV.
PG  - 201-11
AB  - Efficient approaches are needed for obtaining reliable insights into the safety, 
      in developing and developed country settings, of interventions for prevention of 
      mother-to-child transmission (MCT) of HIV. A randomized trial designed with an 
      appropriate sample size and adequate duration of follow-up provides a powerful 
      tool for obtaining causal evidence regarding the safety and efficacy of MTC 
      prevention interventions. Such trials are ideal for detecting adverse effects 
      (AEs) that occur in the short or moderate term and with moderate to high 
      frequency. Passive and active surveillance procedures, where practical, can 
      provide valuable insights regarding long-term or rare AEs. Ideally, surveillance 
      procedures should be carefully planned sufficiently early to allow prospective 
      definition and uniform collection of important classes of AEs, enhancing the 
      sensitivity and specificity of these surveillance data.
FAU - Fleming, T R
AU  - Fleming TR
AD  - Department of Biostatistics, University of Washington, Seattle, Washington 98195, 
      USA.
LA  - eng
GR  - R01 AI-29168/AI/NIAID NIH HHS/United States
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - Ann N Y Acad Sci
JT  - Annals of the New York Academy of Sciences
JID - 7506858
RN  - 0 (Anti-HIV Agents)
SB  - IM
MH  - Anti-HIV Agents/adverse effects/*therapeutic use
MH  - Asthma/therapy
MH  - Child
MH  - Female
MH  - HIV Infections/*prevention & control/transmission
MH  - Humans
MH  - Infant, Newborn
MH  - Infectious Disease Transmission, Vertical/*prevention & control
MH  - Kidney Neoplasms/therapy
MH  - Pregnancy
MH  - Pregnancy Complications, Infectious/*prevention & control
MH  - Randomized Controlled Trials as Topic
MH  - Research Design
MH  - Risk Assessment
MH  - Safety
MH  - Wilms Tumor/therapy
EDAT- 2000/12/29 11:00
MHDA- 2001/02/28 10:01
CRDT- 2000/12/29 11:00
PHST- 2000/12/29 11:00 [pubmed]
PHST- 2001/02/28 10:01 [medline]
PHST- 2000/12/29 11:00 [entrez]
AID - 10.1111/j.1749-6632.2000.tb05490.x [doi]
PST - ppublish
SO  - Ann N Y Acad Sci. 2000 Nov;918:201-11. doi: 10.1111/j.1749-6632.2000.tb05490.x.