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 Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF, Truvada®) for HIV Pre-Exposure Prophylaxis (PrEP): A Pooled Observational Study
This 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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
California
-
Foster City, California, Stati Uniti, 94404
- Gilead Sciences, Inc.
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Participants in an FTC/TDF for PrEP observational or clinical study
- HIV-1 negative individual at the time of enrollment in a demonstration project or clinical study
- Participants with at least one measurement of tenofovir-diphosphate (TFV-DP) in dried blood spot (DBS) or tenofovir (TFV) in plasma
Exclusion Criteria:
- This is an observational study and will collect HIV-1 infection and resistance information along with renal or skeletal adverse events without intervention.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
FTC/TDF for PrEP
HIV-1 negative adults (any sex/gender, including transgender, pregnancy) who are participating in observational or clinical studies on FTC/TDF for PrEP
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Treatment adherence, as measured by drug level, to the once-daily dosing regimen of FTC/TDF for PrEP
Lasso di tempo: Baseline to Year 3
|
Baseline to Year 3
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Time to onset of signs and/or symptoms of acute HIV infection before and after seroconversion during treatment
Lasso di tempo: Baseline to Year 3
|
The time to onset of signs and/or symptoms if acute HIV infection in relation to exposure to study drug will be recorded.
Signs and symptoms include fever, lymphadenopathy, pharyngitis, rash, myalgia, malaise, mouth and esophageal sores, and may also include, but less commonly, headache, nausea and vomiting, enlarged liver/spleen, weight loss, thrush, and neurological symptoms.
|
Baseline to Year 3
|
|
Time to seroconversion during treatment
Lasso di tempo: Baseline to Year 3
|
The time to seroconversion in relation to exposure to study drug will be recorded.
|
Baseline to Year 3
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GS-US-276-0104
- EUPAS24332 (Identificatore di registro: ENCePP)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su HIV
-
Federal University of São PauloGilead SciencesCompletato
-
University of MinnesotaRitiratoInfezioni da HIV | HIV/AIDS | HIV | AIDS | Problema di Aids/Hiv | AIDS e infezioniStati Uniti
-
National Institute of Allergy and Infectious Diseases...Duke University; Department of Health and Human Services (HHS)Non ancora reclutamento
-
Jecho Biopharmaceuticals Co., Ltd.Non ancora reclutamento
-
Boston UniversityBill and Melinda Gates Foundation; HE2RO, University of the WitwatersrandReclutamento
-
National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH); Department of Health and Human ServicesReclutamento
-
University of California, Los AngelesNational Institute of Mental Health (NIMH); Partners in Hope, Inc.Reclutamento
-
Kelley-Ross & Associates, Inc.Gilead SciencesAttivo, non reclutante
-
RTI InternationalNational Institute of Mental Health (NIMH); University of Washington; MU-JHU CAREReclutamento