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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00051090
First received: January 3, 2003
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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).


Condition Intervention
HIV Infections
Hepatitis B
Drug: Telbivudine
Drug: Lamivudine
Drug: Efavirenz
Drug: Didanosine
Drug: Abacavir

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Arms Assigned Interventions
Experimental: A
All eligible study participants
Drug: Telbivudine
Administered orally at a daily dosage of 600 mg for a period of 48 weeks
Drug: Lamivudine
Administered orally at a total daily dosage of 300 mg for Weeks 24-48
Drug: Efavirenz
Administered orally at a daily dose of 600 mg
Drug: Didanosine
Administered orally at a total dosage of either 400 mg or 250 mg determined by individual weight
Drug: Abacavir
Administered orally twice daily in doses of 300 mg

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051090

Sponsors and Collaborators
Investigators
Study Chair: Patrick Lynch, M.D. Northwestern University
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00051090     History of Changes
Other Study ID Numbers: A5167, 10962, ACTG A5167
Study First Received: January 3, 2003
Last Updated: May 17, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Hepatitis B
Antiretroviral Therapy, Highly-Active
HIV Infections
Lamivudine
Reverse Transcriptase Inhibitors
Antiviral Agents
Drug Therapy, Combination
Treatment Naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis A
Hepatitis B
Infection
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Lamivudine
Reverse Transcriptase Inhibitors
Telbivudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on November 23, 2014