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

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Withdrawn

Conditions

Hepatitis B

HIV Infections

Treatments

Drug: Telbivudine

Drug: Abacavir

Drug: Efavirenz

Drug: Didanosine

Drug: Lamivudine

Study type

Interventional

Funder types

NIH

Identifiers

NCT00051090

ACTG A5167

A5167

10962 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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