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Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The imperative to overcome the evidence gap.
Joseph Davey, Dvora L; Bekker, Linda-Gail; Bukusi, Elizabeth A; Chi, Benjamin H; Delany-Moretlwe, Sinead; Goga, Ameena; Lyerly, Anne Drapkin; Mgodi, Nyaradzo M; Mugo, Nelly; Myer, Landon; Noguchi, Lisa M; Stranix-Chibanda, Lynda; Slack, Catherine; Pintye, Jillian.
Afiliação
  • Joseph Davey DL; Department of Epidemiology, Fielding School of Public Health, University of California, Los Angeles, CA, USA; Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, South Africa; The Desmond Tutu HIV Centre, University of Cape Town, Cape Tow
  • Bekker LG; The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
  • Bukusi EA; Centre for Microbiology Reseacrh, Kenya Medical Research Institute, Nairobi, Kenya; Department of Obstetrics and Gynecology, University of Washington, Seattle, WA, USA.
  • Chi BH; Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
  • Delany-Moretlwe S; Wits RHI, University of Witwaterstrand, Johannesburg, South Africa.
  • Goga A; South African Medial Research Council, Cape Town, South Africa; Department of Paediatrics and Child Health, University of Pretoria, Pretoria, South Africa.
  • Lyerly AD; Department of Social Medicine and Center for Bioethics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
  • Mgodi NM; Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.
  • Mugo N; Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya; Department of Global Health, University of Washington, Seattle, WA, USA.
  • Myer L; Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, South Africa.
  • Noguchi LM; Jhpiego, Johns Hopkins University, Baltimore, MD, USA.
  • Stranix-Chibanda L; Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe; Child and Adolescent Health Unit, Faculty of Medicine and Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
  • Slack C; School of Applied Human Sciences, University of KwaZulu Natal, Pietermaritzburg, South Africa.
  • Pintye J; Department of Global Health, University of Washington, Seattle, WA, USA.
Lancet HIV ; 9(3): e214-e222, 2022 03.
Article em En | MEDLINE | ID: mdl-35090604
ABSTRACT
Pregnant and breastfeeding populations are at substantial risk of acquiring HIV in some settings, yet are underrepresented in clinical trials of new pre-exposure prophylaxis (PrEP) agents. Several PrEP formulations are in development (eg, vaginal rings, long-acting injectables, and other modalities). Pregnant and breastfeeding populations are typically excluded from initial clinical trials. We identified 14 PrEP trials of novel agents in non-pregnant or non-breastfeeding populations, and six phase 1-3 trials and open label extensions among pregnant and breastfeeding populations, that are currently ongoing or complete. A framework shift is needed to consider the ethical costs of excluding pregnant and breastfeeding populations at risk for HIV in PrEP clinical trials and promote inclusion to maximise the benefits from PrEP tools in the pipeline. Research on new PrEP agents should include pregnant and breastfeeding populations to avoid delays in reaching those who could benefit from PrEP after efficacy is established.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Infecções por HIV / Fármacos Anti-HIV / Profilaxia Pré-Exposição Limite: Female / Humans / Pregnancy Idioma: En Ano de publicação: 2022 Tipo de documento: Article
Texto completo
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XML
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Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Infecções por HIV / Fármacos Anti-HIV / Profilaxia Pré-Exposição Limite: Female / Humans / Pregnancy Idioma: En Ano de publicação: 2022 Tipo de documento: Article