CAPRISA 018: a phase I/II clinical trial study protocol to assess the safety, acceptability, tolerability and pharmacokinetics of a sustained-release tenofovir alafenamide subdermal implant for HIV prevention in women.
HIV & AIDS
clinical trials
preventive medicine
public health
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
06 Jan 2022
06 Jan 2022
Historique:
entrez:
7
1
2022
pubmed:
8
1
2022
medline:
16
3
2022
Statut:
epublish
Résumé
Young African women bear a disproportionately high risk for HIV acquisition. HIV technologies that empower women to protect themselves are needed. Safe, potent antiretroviral agents such as tenofovir alafenamide (TAF), formulated as long-acting subdermal implants, offer an innovative solution. CAPRISA 018 is a phase I/II trial to evaluate the safety, acceptability, tolerability and pharmacokinetics (PKs) of a TAF The South African Health Products Regulatory Authority and the University of KwaZulu-Natal's Biomedical Research Ethics Committee have approved the trial. Results will be disseminated through open access peer reviewed publications, conference presentations, public stakeholder engagement and upload of data into the clinical trials registry. PACTR201809520959443.
Identifiants
pubmed: 34992111
pii: bmjopen-2021-052880
doi: 10.1136/bmjopen-2021-052880
pmc: PMC8739430
doi:
Substances chimiques
Anti-HIV Agents
0
Delayed-Action Preparations
0
Tenofovir
99YXE507IL
tenofovir alafenamide
EL9943AG5J
Alanine
OF5P57N2ZX
Banques de données
PACTR
['PACTR201809520959443']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e052880Subventions
Organisme : European & Developing Countries Clinical Trials Partnership
ID : EDCTP_SRIA2015-1061
Pays : Netherlands
Informations de copyright
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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