Calendario›GILD›Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Truvada® for HIV Pre-Exposure Prophylaxis (PrEP)

Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Truvada® for HIV Pre-Exposure Prophylaxis (PrEP)

Ensayo de GILEAD SCIENCES, INC. en HIV (del registro, en inglés).

Fase

no aplica

Estado

Completado

Participantes

10.577

previstos

Centros

1

Fin del objetivo primario

abr 2021

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en oct 2013.

Qué mide

Treatment adherence, as measured by drug level, to the once-daily dosing regimen of FTC/TDF for PrEP (del registro, en inglés) (del inicio al año 3)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is an observational study of HIV-1 negative individuals who participated in demonstration projects or clinical studies and took daily Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF, Truvada®) for pre-exposure prophylaxis (PrEP). All individuals were enrolled and followed as described in the parent PrEP demonstration project or clinical study protocol until study completion, HIV-1 infection, discontinuation due to an adverse event, lost to follow-up, or administrative censoring. In the protocols of the parent PrEP observational or clinical studies, participants had follow-up visits on average every 3 months for evaluation of adherence, renal and bone adverse events, and HIV-1 infection status. Adherence was determined by the specific FTC/TDF drug level measurement(s) outlined in the parent protocol. Gilead had collected data from 21 global PrEP demonstration projects and clinical studies for over 7,000 Truvada for PrEP users who had at least one measurement of adherence. Data from the different contributing studies were pooled for statistical analyses by Gilead.

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01906255), actualizada en ago 2021.