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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Abacavir; Didanosine; Efavirenz; Lamivudine; Telbivudine

Criteria

Inclusion Criteria:

• HIV positive

• No antiretroviral therapy within 6 months prior to study entry

• Less than 31 days cumulative therapy with lamivudine, a protease inhibitor, or a nonnucleoside reverse transcriptase inhibitor

• Willingness to delay HAART until at least Week 24 of study

• Ability to procure and initiate HAART regimen

• CD4+ cell count >= 250 cells/mm3 within 60 days prior to study entry

• HIV-1 RNA > 400 copies/ml within 60 days prior to study entry

• Serum HBV DNA >= 1,000,000 copies/ml within 60 days prior to study entry

• Positive serum hepatitis B surface antigen (HbsAG)

• Acceptable methods of contraception

Exclusion Criteria:

• Pregnancy or breast-feeding

• Allergy, sensitivity, or intolerance to study drugs

• Alcohol consumption averaging more than 1 drink/day within past 30 days

• Decompensated cirrhosis

• HCV antibody positive or known HCV RNA positive

• HDV antibody positive

• Certain medical conditions

• Use of certain medications with anti-HBV activity within 90 days of study entry

• Use of systemic corticosteroids within 30 days of study entry

• Use of any systemic antineoplastic, immunomodulatory treatment, or radiation within 24 weeks of study entry