An Open-Label Pharmacokinetic and Pharmacodynamic Assessment of Tenofovir Gel and Oral Emtricitabine/Tenofovir Disoproxil Fumarate.

Anti-HIV Agents / pharmacology Cross-Over Studies Emtricitabine Female HIV Infections / drug therapy HIV-1 Homosexuality, Male Humans Male Pre-Exposure Prophylaxis Reverse Transcriptase Inhibitors / therapeutic use Sexual and Gender Minorities Tenofovir / therapeutic use
HIV emtricitabine microbicide prevention rectal tenofovir

Journal

AIDS research and human retroviruses
ISSN: 1931-8405
Titre abrégé: AIDS Res Hum Retroviruses
Pays: United States
ID NLM: 8709376

Informations de publication

Date de publication:
04 2022
Historique:
pubmed: 21 9 2021
medline: 12 4 2022
entrez: 20 9 2021
Statut: ppublish

Résumé

The Microbicide Trials Network-017 study was undertaken to characterize the safety, acceptability, pharmacokinetic (PK), and pharmacodynamic profile of the reduced-glycerin (RG) 1% tenofovir (RG-TFV) gel compared to oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF). The study was a Phase 2, three-period, randomized sequence, open-label, expanded safety and acceptability crossover study. In each 8-week study period, HIV-1-uninfected participants were randomized to RG-TFV rectal gel daily or RG-TFV rectal gel before and after receptive anal intercourse (RAI) (or at least twice weekly in the event of no RAI), or daily oral FTC/TDF. A mucosal substudy was conducted at sites in the United States and Thailand. Samples were collected to evaluate PK and

Identifiants

DOI: 10.1089/AID.2021.0115 PMID: 34541872 PMC: PMC9048169
pubmed: 34541872
doi: 10.1089/AID.2021.0115
pmc: PMC9048169
doi:

Substances chimiques

Anti-HIV Agents 0
Reverse Transcriptase Inhibitors 0
Tenofovir 99YXE507IL
Emtricitabine G70B4ETF4S

Banques de données

ClinicalTrials.gov
['NCT01687218']

Types de publication

Clinical Trial, Phase II Journal Article Randomized Controlled Trial Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

279-287

Subventions

Organisme : NIAID NIH HHS
ID : UM1 AI068615
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068633
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI106707
Pays : United States

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Auteurs

Ian M McGowan (IM)

Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Orion Biotechnology, Ottawa, Ontario, Canada.
ORCID: 0000-0002-6470-8476

Ratiya Pamela Kunjara Na Ayudhya (RP)

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.

Rhonda M Brand (RM)

Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

Mark A Marzinke (MA)

Department of Medicine, The Johns Hopkins University, Baltimore, Maryland, USA.

Craig W Hendrix (CW)

Department of Medicine, The Johns Hopkins University, Baltimore, Maryland, USA.

Sherri Johnson (S)

FHI 360, Durham, North Carolina, USA.

Jeanna Piper (J)

National Institute of Allergy and Infectious Disease, Bethesda, Maryland, USA.

Timothy H Holtz (TH)

Division of HIV/AIDS Prevention, United States Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Thailand Ministry of Public Health, United States Centers for Disease Control and Prevention Collaboration, Bangkok, Thailand.
Office of AIDS Research, NIH, Bethesda, Maryland, USA.

Marcel E Curlin (ME)

Division of HIV/AIDS Prevention, United States Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Thailand Ministry of Public Health, United States Centers for Disease Control and Prevention Collaboration, Bangkok, Thailand.

Anupong Chitwarakorn (A)

Thailand Ministry of Public Health, United States Centers for Disease Control and Prevention Collaboration, Bangkok, Thailand.

Boonyos Raengsakulrach (B)

Thailand Ministry of Public Health, United States Centers for Disease Control and Prevention Collaboration, Bangkok, Thailand.

Gustavo Doncel (G)

CONRAD/Eastern Virginia Medical School, Arlington, Virginia, USA.

Jill L Schwartz (JL)

CONRAD/Eastern Virginia Medical School, Arlington, Virginia, USA.

James F Rooney (JF)

Gilead Sciences, Foster City, California, USA.

Ross D Cranston (RD)

Department of Medicine, University of Barcelona, Barcelona, Spain.
ORCID: 0000-0002-2687-6217

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Classifications MeSH

questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Anti-infectieux › Antiviraux › Antirétroviraux › Agents antiVIH › An Open-Label Pharmacokinetic and...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Études croisées › An Open-Label Pharmacokinetic and...
questionsmedicales.fr › Acides nucléiques, nucléotides et nucléosides › Nucléosides › Nucléosides pyrimidiques › Désoxycytidine › Emtricitabine › An Open-Label Pharmacokinetic and...
questionsmedicales.fr › Maladies du système immunitaire › Déficits immunitaires › Infections à VIH › An Open-Label Pharmacokinetic and...
questionsmedicales.fr › Virus › Virus à ARN › Retroviridae › Lentivirus › Lentivirus des primates › VIH (Virus de l'Immunodéficience Humaine) › VIH-1 (Virus de l'Immunodéficience Humaine de type 1) › An Open-Label Pharmacokinetic and...
questionsmedicales.fr › Phénomènes physiologiques des appareils urinaire et reproducteur › Phénomènes physiologiques de la reproduction › Sexualité › Homosexualité › Homosexualité masculine › An Open-Label Pharmacokinetic and...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › An Open-Label Pharmacokinetic and...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Pratiques en santé publique › Prévention primaire › Prophylaxie pré-exposition › An Open-Label Pharmacokinetic and...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Anti-infectieux › Antiviraux › Inhibiteurs de la transcriptase inverse › An Open-Label Pharmacokinetic and...
questionsmedicales.fr › Personnes › Disparités en matière de santé, minorités et populations vulnérables › Minorités sexuelles › An Open-Label Pharmacokinetic and...
questionsmedicales.fr › Composés hétérocycliques › Composés hétérocycliques à cycles fusionnés › Composés hétérobicycliques › Purines › Adénine › Ténofovir › An Open-Label Pharmacokinetic and...