Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-27 @ 9:36 AM
Study NCT ID:
NCT00127959
Status:
COMPLETED
Last Update Posted:
2007-04-24
First Post:
2005-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection
Sponsor:
International Antiviral Therapy Evaluation Center
Organization:
Study Overview
Official Title:
Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naïve Patients With HIV/HBV 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 (TDF)/FTC in antiretroviral naive subjects with HIV/HBV 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 TDF/FTC in antiretroviral naive subjects with HIV/HBV 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 copies/ml) 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 (ALT\>5x ULN)
* To compare suppression of HIV-1 RNA and changes in CD4/CD8 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 HIV/HBV co-infection who are naive to HIV/HBV 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 copies/ml
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 copies/ml) 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 (ALT\>5x ULN)
* To compare suppression of HIV-1 RNA and changes in CD4/CD8 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 HIV/HBV co-infection who are naive to HIV/HBV 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 copies/ml
Randomization:
* Arm 1: Zidovudine (AZT), emtricitabine (FTC), efavirenz (EFV)
* Arm 2: Tenofovir (TDF), emtricitabine (FTC), efavirenz (EFV)
Study Oversight
Has Oversight DMC:
False
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?: