A pilot study to evaluate the safety and feasibility of the administration of AZT/3TC fixed dose combination to HIV infected pregnant women and their infants in Rio de Janeiro, Brazil
Identifieur interne : 000A94 ( Main/Exploration ); précédent : 000A93; suivant : 000A95A pilot study to evaluate the safety and feasibility of the administration of AZT/3TC fixed dose combination to HIV infected pregnant women and their infants in Rio de Janeiro, Brazil
Auteurs : J S Lambert [Royaume-Uni] ; S A Nogueira [Brésil] ; T. Abreu [Brésil] ; E S Machado [Brésil] ; T P Costa [Brésil] ; M. Bondarovsky [Brésil] ; M. Andrade [Brésil] ; M. Halpern [Brésil] ; R. Barbosa [Brésil] ; M. Perez [Brésil]Source :
- Sexually Transmitted Infections [ 1368-4973 ] ; 2003-12.
Descripteurs français
- Wicri :
- geographic : Brésil.
English descriptors
- KwdEn :
Abstract
Objectives: To evaluate the safety and feasibility of zidovudine and lamivudine (AZT/3TC) given to HIV infected pregnant women and their infants in Rio de Janeiro, Brazil. Methods: This open label phase II study enrolled 40 HIV infected antiretroviral naive women ⩾20 weeks gestation, CD4 <500 cells ×106/l, from two public hospitals. Treatment: fixed dose AZT 300 mg/3TC 150 mg by mouth every 12 hours until labour; AZT 300 mg by mouth every 3 hours until delivery; infants: AZT 4 mg/kg every 12 hours plus 3TC 2 mg/kg every 12 hours for 6 weeks. Blood haematology and chemistry were monitored; adherence evaluated by pills count; efficacy measured by changes in lymphocyte (CD4) and viral load, and by HIV RNA-PCR tests performed at birth, 6 and 12 weeks, to diagnose infant infection. No women breast fed. Results: Patient characteristics: mean age 24.48 (SD 3.5) years; gestational age 24.5 (4.5) weeks; AZT/3TC duration 14.4 (4.4) weeks; vaginal delivery: 11/39; caesarean section: 28/39. Entry and pre-labour CD4: 310/486 cells ×106/l (p<0.001); entry and pre-labour viral load: 53 818/2616 copies/ml (p<0.001). Thirty nine women tolerated treatment with >80% adherence; one was lost to follow up. Five newborns were excluded from 3TC receipt. All 39 babies were uninfected. Haematological toxicity in newborns was common: anaemia in 27; neutropenia in five (two severe); platelets counts <100 000 in two. All values recovered on study completion. Conclusions: Fixed dose AZT/3TC is well accepted, gives improvements in CD4 and viral load; no infants were HIV infected. Haematological toxicity in infants needs careful monitoring.
Url:
DOI: 10.1136/sti.79.6.448
Affiliations:
Links toward previous steps (curation, corpus...)
- to stream Istex, to step Corpus: 000D13
- to stream Istex, to step Curation: 000D13
- to stream Istex, to step Checkpoint: 000706
- to stream Main, to step Merge: 000B23
- to stream Main, to step Curation: 000A94
Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">A pilot study to evaluate the safety and feasibility of the administration of AZT/3TC fixed dose combination to HIV infected pregnant women and their infants in Rio de Janeiro, Brazil</title><author><name sortKey="Lambert, J S" sort="Lambert, J S" uniqKey="Lambert J" first="J S" last="Lambert">J S Lambert</name></author><author><name sortKey="Nogueira, S A" sort="Nogueira, S A" uniqKey="Nogueira S" first="S A" last="Nogueira">S A Nogueira</name></author><author><name sortKey="Abreu, T" sort="Abreu, T" uniqKey="Abreu T" first="T" last="Abreu">T. Abreu</name></author><author><name sortKey="Machado, E S" sort="Machado, E S" uniqKey="Machado E" first="E S" last="Machado">E S Machado</name></author><author><name sortKey="Costa, T P" sort="Costa, T P" uniqKey="Costa T" first="T P" last="Costa">T P Costa</name></author><author><name sortKey="Bondarovsky, M" sort="Bondarovsky, M" uniqKey="Bondarovsky M" first="M" last="Bondarovsky">M. Bondarovsky</name></author><author><name sortKey="Andrade, M" sort="Andrade, M" uniqKey="Andrade M" first="M" last="Andrade">M. Andrade</name></author><author><name sortKey="Halpern, M" sort="Halpern, M" uniqKey="Halpern M" first="M" last="Halpern">M. Halpern</name></author><author><name sortKey="Barbosa, R" sort="Barbosa, R" uniqKey="Barbosa R" first="R" last="Barbosa">R. Barbosa</name></author><author><name sortKey="Perez, M" sort="Perez, M" uniqKey="Perez M" first="M" last="Perez">M. Perez</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:798F38A4810685E23BB2A795515371631B791613</idno><date when="2003" year="2003">2003</date><idno type="doi">10.1136/sti.79.6.448</idno><idno type="url">https://api.istex.fr/document/798F38A4810685E23BB2A795515371631B791613/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000D13</idno><idno type="wicri:Area/Istex/Curation">000D13</idno><idno type="wicri:Area/Istex/Checkpoint">000706</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Checkpoint">000706</idno><idno type="wicri:doubleKey">1368-4973:2003:Lambert J:a:pilot:study</idno><idno type="wicri:Area/Main/Merge">000B23</idno><idno type="wicri:Area/Main/Curation">000A94</idno><idno type="wicri:Area/Main/Exploration">000A94</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">A pilot study to evaluate the safety and feasibility of the administration of AZT/3TC fixed dose combination to HIV infected pregnant women and their infants in Rio de Janeiro, Brazil</title><author><name sortKey="Lambert, J S" sort="Lambert, J S" uniqKey="Lambert J" first="J S" last="Lambert">J S Lambert</name><affiliation wicri:level="3"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>University of Maryland Institute of Human Virology, Baltimore, Maryland, USA, and the Institute of Child Health, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Nogueira, S A" sort="Nogueira, S A" uniqKey="Nogueira S" first="S A" last="Nogueira">S A Nogueira</name><affiliation wicri:level="1"><country xml:lang="fr">Brésil</country><wicri:regionArea>HUCFF/IPPMG/ME-Federal University of Rio de Janeiro</wicri:regionArea></affiliation></author><author><name sortKey="Abreu, T" sort="Abreu, T" uniqKey="Abreu T" first="T" last="Abreu">T. Abreu</name><affiliation wicri:level="1"><country xml:lang="fr">Brésil</country><wicri:regionArea>HUCFF/IPPMG/ME-Federal University of Rio de Janeiro</wicri:regionArea></affiliation></author><author><name sortKey="Machado, E S" sort="Machado, E S" uniqKey="Machado E" first="E S" last="Machado">E S Machado</name><affiliation wicri:level="1"><country xml:lang="fr">Brésil</country><wicri:regionArea>HUCFF/IPPMG/ME-Federal University of Rio de Janeiro</wicri:regionArea></affiliation></author><author><name sortKey="Costa, T P" sort="Costa, T P" uniqKey="Costa T" first="T P" last="Costa">T P Costa</name><affiliation wicri:level="1"><country xml:lang="fr">Brésil</country><wicri:regionArea>HUCFF/IPPMG/ME-Federal University of Rio de Janeiro</wicri:regionArea></affiliation></author><author><name sortKey="Bondarovsky, M" sort="Bondarovsky, M" uniqKey="Bondarovsky M" first="M" last="Bondarovsky">M. Bondarovsky</name><affiliation wicri:level="1"><country xml:lang="fr">Brésil</country><wicri:regionArea>HUCFF/IPPMG/ME-Federal University of Rio de Janeiro</wicri:regionArea></affiliation></author><author><name sortKey="Andrade, M" sort="Andrade, M" uniqKey="Andrade M" first="M" last="Andrade">M. Andrade</name><affiliation wicri:level="1"><country xml:lang="fr">Brésil</country><wicri:regionArea>HUCFF/IPPMG/ME-Federal University of Rio de Janeiro</wicri:regionArea></affiliation></author><author><name sortKey="Halpern, M" sort="Halpern, M" uniqKey="Halpern M" first="M" last="Halpern">M. Halpern</name><affiliation wicri:level="3"><country xml:lang="fr">Brésil</country><wicri:regionArea>Hospital Raphael de Paula Souza (HRPS), Rio de Janeiro</wicri:regionArea><placeName><settlement type="city">Rio de Janeiro</settlement><region type="state">État de Rio de Janeiro</region></placeName></affiliation></author><author><name sortKey="Barbosa, R" sort="Barbosa, R" uniqKey="Barbosa R" first="R" last="Barbosa">R. Barbosa</name><affiliation wicri:level="3"><country xml:lang="fr">Brésil</country><wicri:regionArea>Hospital Raphael de Paula Souza (HRPS), Rio de Janeiro</wicri:regionArea><placeName><settlement type="city">Rio de Janeiro</settlement><region type="state">État de Rio de Janeiro</region></placeName></affiliation></author><author><name sortKey="Perez, M" sort="Perez, M" uniqKey="Perez M" first="M" last="Perez">M. Perez</name><affiliation wicri:level="1"><country xml:lang="fr">Brésil</country><wicri:regionArea>HUCFF/IPPMG/ME-Federal University of Rio de Janeiro</wicri:regionArea></affiliation></author></analytic><monogr></monogr><series><title level="j">Sexually Transmitted Infections</title><title level="j" type="abbrev">Sex Transm Infect</title><idno type="ISSN">1368-4973</idno><idno type="eISSN">1472-3263</idno><imprint><publisher>BMJ Publishing Group Ltd</publisher><date type="published" when="2003-12">2003-12</date><biblScope unit="volume">79</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="448">448</biblScope></imprint><idno type="ISSN">1368-4973</idno></series><idno type="istex">798F38A4810685E23BB2A795515371631B791613</idno><idno type="DOI">10.1136/sti.79.6.448</idno><idno type="href">sextrans-79-448.pdf</idno><idno type="PMID">14663118</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1368-4973</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Brazil</term><term>HIV</term><term>mother to child transmission</term><term>paediatric AIDS</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Brésil</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Objectives: To evaluate the safety and feasibility of zidovudine and lamivudine (AZT/3TC) given to HIV infected pregnant women and their infants in Rio de Janeiro, Brazil. Methods: This open label phase II study enrolled 40 HIV infected antiretroviral naive women ⩾20 weeks gestation, CD4 <500 cells ×106/l, from two public hospitals. Treatment: fixed dose AZT 300 mg/3TC 150 mg by mouth every 12 hours until labour; AZT 300 mg by mouth every 3 hours until delivery; infants: AZT 4 mg/kg every 12 hours plus 3TC 2 mg/kg every 12 hours for 6 weeks. Blood haematology and chemistry were monitored; adherence evaluated by pills count; efficacy measured by changes in lymphocyte (CD4) and viral load, and by HIV RNA-PCR tests performed at birth, 6 and 12 weeks, to diagnose infant infection. No women breast fed. Results: Patient characteristics: mean age 24.48 (SD 3.5) years; gestational age 24.5 (4.5) weeks; AZT/3TC duration 14.4 (4.4) weeks; vaginal delivery: 11/39; caesarean section: 28/39. Entry and pre-labour CD4: 310/486 cells ×106/l (p<0.001); entry and pre-labour viral load: 53 818/2616 copies/ml (p<0.001). Thirty nine women tolerated treatment with >80% adherence; one was lost to follow up. Five newborns were excluded from 3TC receipt. All 39 babies were uninfected. Haematological toxicity in newborns was common: anaemia in 27; neutropenia in five (two severe); platelets counts <100 000 in two. All values recovered on study completion. Conclusions: Fixed dose AZT/3TC is well accepted, gives improvements in CD4 and viral load; no infants were HIV infected. Haematological toxicity in infants needs careful monitoring.</div></front></TEI><affiliations><list><country><li>Brésil</li><li>Royaume-Uni</li></country><region><li>Angleterre</li><li>Grand Londres</li><li>État de Rio de Janeiro</li></region><settlement><li>Londres</li><li>Rio de Janeiro</li></settlement></list><tree><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Lambert, J S" sort="Lambert, J S" uniqKey="Lambert J" first="J S" last="Lambert">J S Lambert</name></region></country><country name="Brésil"><noRegion><name sortKey="Nogueira, S A" sort="Nogueira, S A" uniqKey="Nogueira S" first="S A" last="Nogueira">S A Nogueira</name></noRegion><name sortKey="Abreu, T" sort="Abreu, T" uniqKey="Abreu T" first="T" last="Abreu">T. Abreu</name><name sortKey="Andrade, M" sort="Andrade, M" uniqKey="Andrade M" first="M" last="Andrade">M. Andrade</name><name sortKey="Barbosa, R" sort="Barbosa, R" uniqKey="Barbosa R" first="R" last="Barbosa">R. Barbosa</name><name sortKey="Bondarovsky, M" sort="Bondarovsky, M" uniqKey="Bondarovsky M" first="M" last="Bondarovsky">M. Bondarovsky</name><name sortKey="Costa, T P" sort="Costa, T P" uniqKey="Costa T" first="T P" last="Costa">T P Costa</name><name sortKey="Halpern, M" sort="Halpern, M" uniqKey="Halpern M" first="M" last="Halpern">M. Halpern</name><name sortKey="Machado, E S" sort="Machado, E S" uniqKey="Machado E" first="E S" last="Machado">E S Machado</name><name sortKey="Perez, M" sort="Perez, M" uniqKey="Perez M" first="M" last="Perez">M. Perez</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Eau/explor/LotaV3/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000A94 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 000A94 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Eau
|area= LotaV3
|flux= Main
|étape= Exploration
|type= RBID
|clé= ISTEX:798F38A4810685E23BB2A795515371631B791613
|texte= A pilot study to evaluate the safety and feasibility of the administration of AZT/3TC fixed dose combination to HIV infected pregnant women and their infants in Rio de Janeiro, Brazil
}}
| This area was generated with Dilib version V0.6.39. |  |