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Clinical Trials

MainTitle

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

This study has been withdrawn
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)


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
History of Changes
Purpose

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
Intervention Model: Single Group Assignment
Masking: None (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

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 ]
  • Safety and tolerability of telbivudine [ Time Frame: Throughout study ]
Secondary Outcome Measures:
  • Safety and tolerability of HAART [ Time Frame: Throughout study ]
  • Change in ALT level [ Time Frame: Throughout study ]
  • HBV genetic mutation status at HBV virologic failure [ Time Frame: Throughout study ]
  • HIV viral load [ Time Frame: At Study entry, Weeks 24, 48, and 60 ]
  • HBV viral load and hepatic transaminase concentrations [ Time Frame: At Week 60 ]

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair: Patrick Lynch, M.D. Northwestern University
More Information

More Information


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  

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:
Hepatitis
Hepatitis A
HIV Infections
Hepatitis B
Lamivudine
Efavirenz
Abacavir
Didanosine
Telbivudine

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.