Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients With Both HBV and HIV
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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- HBV viral loads [ Time Frame: At Study entry, Week 24 and Week 48 ] [ Designated as safety issue: No ]
- Safety and tolerability of telbivudine [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Safety and tolerability of HAART [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Change in ALT level [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- HBV genetic mutation status at HBV virologic failure [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- HIV viral load [ Time Frame: At Study entry, Weeks 24, 48, and 60 ] [ Designated as safety issue: No ]
- HBV viral load and hepatic transaminase concentrations [ Time Frame: At Week 60 ] [ Designated as safety issue: No ]
All eligible study participants
Administered orally at a daily dosage of 600 mg for a period of 48 weeksDrug: Lamivudine
Administered orally at a total daily dosage of 300 mg for Weeks 24-48Drug: Efavirenz
Administered orally at a daily dose of 600 mgDrug: Didanosine
Administered orally at a total dosage of either 400 mg or 250 mg determined by individual weightDrug: Abacavir
Administered orally twice daily in doses of 300 mg
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.
|Study Chair:||Patrick Lynch, M.D.||Northwestern University|