Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051090
Status:
WITHDRAWN
Last Update Posted:
2021-11-01
First Post:
2003-01-03
Brief Title:
Treatment of Hepatitis B Virus HBV Before Beginning Anti-HIV Drugs in Patients With Both HBV and HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Multicenter Pilot Study of Telbivudine LdT Anti-HBV Treatment Prior to the Initiation of Highly Active Antiretroviral Therapy Containing Lamivudine in Subjects Coinfected With HBV and HIV
Status:
WITHDRAWN
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:
This study will evaluate the drug telbivudine LdT for treatment of hepatitis B virus HBV in HIV infected patients Patients will take telbivudine alone for 24 weeks add anti-HIV drugs for 24 weeks then stop taking telbivudine while continuing their anti-HIV drug regimen To enroll in this study patients must not be taking any anti-HIV drugs and cannot have taken more than 31 days of treatment with lamivudine 3TC protease inhibitors PIs or nonnucleoside reverse transcriptase inhibitors NNRTIs
Detailed Description:
Studies indicate that 70 to 80 of HIV infected patients have or have had HBV infection and that 10 are HBV carriers Lamivudine therapy for treatment of HBV in HIV infected patients has limited long-term efficacy due to the development of resistance mutations Telbivudine is a thymidine analogue with excellent HBV inhibitory activity but no anti-HIV activity The primary objective of this study is to evaluate the safety and anti-HBV activity of telbivudine alone and in combination with a lamivudine-based highly active antiretroviral therapy HAART regimen in patients coinfected with HBV and HIV
Patients in this study will take telbivudine for 24 weeks At Week 24 patients will add a HAART regimen containing lamivudine and efavirenz plus either didanosine or abacavir Patients who are unable to add a HAART regimen at Week 24 due to lab abnormalities or other contraindications will be allowed to delay the initiation of HAART until Week 30 Patients may initiate HAART prior to Week 24 if deemed medically necessary by the primary HIV care provider Patients will take both telbivudine and HAART for 24 weeks At Week 48 patients will discontinue telbivudine and continue on the HAART regimen alone for an additional 12 weeks
Patients in this study will take telbivudine for 24 weeks At Week 24 patients will add a HAART regimen containing lamivudine and efavirenz plus either didanosine or abacavir Patients who are unable to add a HAART regimen at Week 24 due to lab abnormalities or other contraindications will be allowed to delay the initiation of HAART until Week 30 Patients may initiate HAART prior to Week 24 if deemed medically necessary by the primary HIV care provider Patients will take both telbivudine and HAART for 24 weeks At Week 48 patients will discontinue telbivudine and continue on the HAART regimen alone for an additional 12 weeks
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 |
|---|---|---|---|
| ACTG A5167 | Registry Identifier | DAIDS ES | None |
| 10962 | REGISTRY | None | None |