Document Detail


Short-course zidovudine for perinatal HIV-1 transmission in Bangkok, Thailand: a randomised controlled trial. Bangkok Collaborative Perinatal HIV Transmission Study Group.
MedLine Citation:
PMID:  10459957     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Many developing countries have not implemented the AIDS Clinical Trials Group 076 zidovudine regimen for prevention of perinatal HIV-1 transmission because of its complexity and cost. We investigated the safety and efficacy of short-course oral zidovudine administered during late pregnancy and labour. METHODS: In a randomised, double-blind, placebo-controlled trial, HIV-1-infected pregnant women at two Bangkok hospitals were randomly assigned placebo or one zidovudine 300 mg tablet twice daily from 36 weeks' gestation and every 3 h from onset of labour until delivery. Mothers were given infant formula and asked not to breastfeed. The main endpoint was babies' HIV-1-infection status, tested with HIV-1-DNA PCR at birth, 2 months, and 6 months. We measured maternal plasma viral concentrations by RNA PCR. FINDINGS: Between May, 1996, and December, 1997, 397 women were randomised; 393 gave birth to 395 live-born babies. Median duration of antenatal treatment was 25 days, and median number of doses during labour was three. 99% of women took at least 90% of scheduled antenatal doses. Adverse events were similar in the study groups. Of 392 babies with at least one PCR test, 55 tested positive: 18 in the zidovudine group and 37 in the placebo group. The estimated transmission risks were 9.4% (95% CI 5.2-13.5) on zidovudine and 18.9% (13.2-24.2) on placebo (p=0.006; efficacy 50.1% [15.4-70.6]). Between enrolment and delivery, women in the zidovudine group had a mean decrease in viral load of 0.56 log. About 80% of the treatment effect was explained by lowered maternal viral concentrations at delivery. INTERPRETATION: A short course of twice-daily oral zidovudine was safe and well tolerated and, in the absence of breastfeeding, can lessen the risk for mother-to-child HIV-1 transmission by half. This regimen could prevent many HIV-1 infections during late pregnancy and labour in less-developed countries unable to implement the full 076 regimen.
Authors:
N Shaffer; R Chuachoowong; P A Mock; C Bhadrakom; W Siriwasin; N L Young; T Chotpitayasunondh; S Chearskul; A Roongpisuthipong; P Chinayon; J Karon; T D Mastro; R J Simonds
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Lancet     Volume:  353     ISSN:  0140-6736     ISO Abbreviation:  Lancet     Publication Date:  1999 Mar 
Date Detail:
Created Date:  1999-08-31     Completed Date:  1999-08-31     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  773-80     Citation Subset:  AIM; IM; X    
Affiliation:
99277089 Collaborative, Nonthaburi, Thailand. nas4@cdc.gov
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adult
Anti-HIV Agents / administration & dosage,  therapeutic use
Double-Blind Method
Female
Follow-Up Studies
HIV Infections / epidemiology,  transmission*
HIV-1 / drug effects*
Humans
Infant, Newborn
Infectious Disease Transmission, Vertical / prevention & control*
Logistic Models
Perinatal Care
Pregnancy
Pregnancy Complications, Infectious / epidemiology,  prevention & control*
Thailand / epidemiology
Zidovudine / administration & dosage,  therapeutic use*
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 30516-87-1/Zidovudine
Comments/Corrections
Comment In:
Lancet. 1999 Jul 10;354(9173):156; author reply 157-8   [PMID:  10408505 ]
Lancet. 1999 Jul 10;354(9173):158   [PMID:  10408507 ]
Lancet. 1999 Jul 10;354(9173):156-8   [PMID:  10408506 ]
Lancet. 1999 Jul 10;354(9173):158-9   [PMID:  10408508 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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