Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127959
Status:
COMPLETED
Last Update Posted:
2007-04-24
First Post:
2005-08-08
Brief Title:
Virological and Clinical Anti-Hepatitis B Virus HBV Efficacy of Tenofovir and Emtricitabine in Patients With HIVHBV co-Infection
Sponsor:
International Antiviral Therapy Evaluation Center
Organization:
International Antiviral Therapy Evaluation Center
Study Overview
Official Title:
Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naïve Patients With HIVHBV co-Infection
Status:
COMPLETED
Status Verified Date:
2007-04
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:
This is a randomized multicentre trial of emtricitabine FTC versus tenofovir TDFFTC in antiretroviral naive subjects with HIVHBV co-infection over 48 weeks Clinical Trial A
Plus a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted Substudy A1
Plus a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted Substudy A1
Detailed Description:
This is a randomized multicentre trial of FTC vs TDFFTC in antiretroviral naive subjects with HIVHBV co-infection over 48 weeks Clinical Trial A
Plus a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted Substudy A1
Primary Objectives
To compare the proportion of subjects with HBV DNA levels below the limit of detection 400 copiesml by week 48 in each treatment group
Secondary Objectives
To evaluate the emergence of HBV resistance at 48 weeks
To compare the proportion of patients with undetectable HBV DNA at weeks 12 and 24 in each treatment group
To compare the proportion of patients who achieve HBeAg and HBsAg seroconversion at weeks 12 24 and 48 during the study
To compare changes in ALT from baseline and the rate of hepatic cytolysis ALT5x ULN
To compare suppression of HIV-1 RNA and changes in CD4CD8 counts over 48 weeks
To compare the effect of therapy on histological changes in the liver and the presence of ccc-DNA
Enrollment
24 patients in Clinical trial A of whom 16 enter substudy A1
Clinical Trial A
Patients with HIVHBV co-infection who are naive to HIVHBV therapy have detectable HBV viraemia and are willing to start antiretroviral therapy
Inclusion Criteria
Written informed consent
Documented HIV infection
Age 18 - 70 years
HBV DNA 106 copiesml
Randomization
Arm 1 Zidovudine AZT emtricitabine FTC efavirenz EFV
Arm 2 Tenofovir TDF emtricitabine FTC efavirenz EFV
Plus a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted Substudy A1
Primary Objectives
To compare the proportion of subjects with HBV DNA levels below the limit of detection 400 copiesml by week 48 in each treatment group
Secondary Objectives
To evaluate the emergence of HBV resistance at 48 weeks
To compare the proportion of patients with undetectable HBV DNA at weeks 12 and 24 in each treatment group
To compare the proportion of patients who achieve HBeAg and HBsAg seroconversion at weeks 12 24 and 48 during the study
To compare changes in ALT from baseline and the rate of hepatic cytolysis ALT5x ULN
To compare suppression of HIV-1 RNA and changes in CD4CD8 counts over 48 weeks
To compare the effect of therapy on histological changes in the liver and the presence of ccc-DNA
Enrollment
24 patients in Clinical trial A of whom 16 enter substudy A1
Clinical Trial A
Patients with HIVHBV co-infection who are naive to HIVHBV therapy have detectable HBV viraemia and are willing to start antiretroviral therapy
Inclusion Criteria
Written informed consent
Documented HIV infection
Age 18 - 70 years
HBV DNA 106 copiesml
Randomization
Arm 1 Zidovudine AZT emtricitabine FTC efavirenz EFV
Arm 2 Tenofovir TDF emtricitabine FTC efavirenz EFV
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