Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391638
Status:
COMPLETED
Last Update Posted:
2015-01-15
First Post:
2006-10-23
Brief Title:
Efficacy and Tolerance of Peg-interferon Alpha 2a Added to Tenofovir and Emtricitabine in AgHBe Positive HBV-HIV Co-infected Patients
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
Pilot Study on Efficacy and Tolerance of Peg-interferon Alpha-2a Pegasys Added to Tenofovir DF and Emtricitabine Truvada in AGHBe Positive HBV-HIV Co-infected Patients ANRS HB 01 EMVIPEG
Status:
COMPLETED
Status Verified Date:
2015-01
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:
HB01EMVIPEG
Brief Summary:
HBe seroconversion is an important goal for anti-HBV treatment since it is associated with a non progressive liver infection and a better clinical outcome However the rate of HBe seroconversion is low in HIV-HBV co-infected patients mostly treated by tenofovir and emtricitabine This study will evaluate the efficacy and the safety of a one-year Peg-interferon alpha 2a additional treatment in patients already treated by tenofovir and emtricitabine without reaching HBe seroconversion
Detailed Description:
Many HBV-HIV co-infected patients are currently treated with dual activity drugs such as tenofovir and emtricitabine often in combination However despite the potent antiviral activity of these drugs the rate of HBe seroconversion is quite low and not always sustained over time HBe seroconversion is an important goal for anti-HBV treatment since it is associated with a non progressive liver infection and a better clinical outcome On the other hand treatments with antiviral and immuno-modulator activity such as Peg-interferon are infrequently used in co-infected patients despite promising data in the field of HBV mono-infection with increased rates and sustained HBe seroconversions This pilot study will evaluate the efficacy and the safety of a one-year Peg-interferon alpha 2a additional treatment 180 micro-g once a week by injection in 55 patients already treated by tenofovir and emtricitabine for at least 6 months and who did not reached HBe seroconversion
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ANRS HB 01 EMVIPEG | None | None | None |