Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033163
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2002-04-08
Brief Title:
A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Phase II Controlled Trial Comparing the Efficacy of Adefovir Dipivoxil and Tenofovir Disoproxil Fumarate for the Treatment of Lamivudine-Resistant Hepatitis B Virus in Subjects Who Are Co-Infected With HIV
Status:
COMPLETED
Status Verified Date:
2021-10
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:
Control of hepatitis B virus HBV infection can be difficult in HIV infected people who have taken the antiviral lamivudine 3TC These people may have HBV that has become resistant to 3TC Adefovir dipivoxil ADV has shown promising anti-HBV activity in clinical trials tenofovir disoproxil fumarate TDF is used to treat HIV and may also be effective against HBV The purpose of this study is to find out if adding ADV or TDF to a highly active antiretroviral therapy HAART regimen that includes 3TC has an effect on HBV infection in patients coinfected with HIV and HBV The tolerability and safety of these drugs will be examined
Detailed Description:
HBV presents a worldwide health crisis and is difficult to treat when a patients HBV strain is no longer responsive to 3TC Given the significant incidence of 3TC-resistant HBV in patients receiving this drug as part of an antiretroviral regimen other agents with anti-HBV activity are needed ADV has shown promising anti-HBV activity in preclinical assessments and in Phase I II and III clinical trials TDF developed for the treatment of HIV infection has in vitro activity against HBV This study will compare TDF3TC combination therapy with ADV3TC combination therapy to determine which treatment regimen is more effective in patients coinfected with HBV and HIV
This study will include two populations of patients Patients in Population A are on stable HAART that includes TDF and will either be in Group I compensated liver disease or Group II decompensated liver disease All patients in Population A will be randomly assigned to one of two arms Arm 1 patients will receive 10 mg ADV daily and TDF placebo Arm 2 patients will receive ADV placebo and 300 mg TDF Patients in Population B are on stable HAART and have never taken TDF as part of their HAART Population B patients will receive 300 mg TDF daily during the course of the study
Study visits will occur every 4 weeks for the 96-week study period Targeted clinical and medication assessments and blood work assessing clotting time liver function and blood chemistry will be conducted at each study visit HIV and HBV DNA viral load will be tested every 12 weeks CD4 cell counts will be tested at Weeks 24 48 72 and 96
This study will include two populations of patients Patients in Population A are on stable HAART that includes TDF and will either be in Group I compensated liver disease or Group II decompensated liver disease All patients in Population A will be randomly assigned to one of two arms Arm 1 patients will receive 10 mg ADV daily and TDF placebo Arm 2 patients will receive ADV placebo and 300 mg TDF Patients in Population B are on stable HAART and have never taken TDF as part of their HAART Population B patients will receive 300 mg TDF daily during the course of the study
Study visits will occur every 4 weeks for the 96-week study period Targeted clinical and medication assessments and blood work assessing clotting time liver function and blood chemistry will be conducted at each study visit HIV and HBV DNA viral load will be tested every 12 weeks CD4 cell counts will be tested at Weeks 24 48 72 and 96
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 |
|---|---|---|---|
| AACTG A5127 | Registry Identifier | DAIDS ES | None |
| 10678 | REGISTRY | None | None |
| ACTG A5127 | None | None | None |