drugset / Trial / NCT00051090

Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients With Both HBV and HIV

NCT00051090

Non-randomizedSingle-groupOpen-labelTreatment

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).

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Telbivudine Small molecule 600 mg Oral
Background Abacavir Other / unclassified 300 mg Oral
Background Didanosine Small molecule 250 mg Oral
Background Didanosine Small molecule 400 mg Oral
Background Efavirenz Other / unclassified 600 mg Oral
Background Lamivudine Other / unclassified 300 mg Oral