| Short-course zidovudine for perinatal HIV-1 transmission in Bangkok, Thailand: a randomised controlled trial. Bangkok Collaborative Perinatal HIV Transmission Study Group. | |
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MedLine Citation:
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PMID: 10459957 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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Title: Lancet Volume: 353 ISSN: 0140-6736 ISO Abbreviation: Lancet Publication Date: 1999 Mar |
Date Detail:
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Created Date: 1999-08-31 Completed Date: 1999-08-31 Revised Date: 2008-11-21 |
Medline Journal Info:
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Nlm Unique ID: 2985213R Medline TA: Lancet Country: ENGLAND |
Other Details:
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Languages: eng Pagination: 773-80 Citation Subset: AIM; IM; X |
Affiliation:
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99277089 Collaborative, Nonthaburi, Thailand. nas4@cdc.gov |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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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:
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0/Anti-HIV Agents; 30516-87-1/Zidovudine |
| Comments/Corrections | |
Comment In:
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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 ] |
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