Viewing Study NCT00476463



Ignite Creation Date: 2024-05-05 @ 5:33 PM
Last Modification Date: 2024-10-26 @ 9:33 AM
Study NCT ID: NCT00476463
Status: COMPLETED
Last Update Posted: 2016-02-22
First Post: 2007-05-20

Brief Title: Efficacy of Tenofovir and Emtricitabine in ARV-naive Patients With HIVHBV Co-infection
Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Organization: The HIV Netherlands Australia Thailand Research Collaboration

Study Overview

Official Title: Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naive Patients With HIVHBV Co-infection
Status: COMPLETED
Status Verified Date: 2016-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Combination therapy with anti-HBV activity may both increase HBV suppression rates and reduce emergence of resistant strains Several new therapeutic agents are currently in development however combination therapy trials in the HBV-infected population have only recently commenced No such trials have been undertaken in the HIVHBV co-infected population
Detailed Description: The primary study objective is to compare HBV DNA suppression to levels below the limit of detection 400 copiesml by week 48 in each treatment group Virological and clinical anti-HBV efficacy of tenofovir and emtricitabine in antiretroviral naive patients with HIVHBV co-infection

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None