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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00051090
Recruitment Status : Withdrawn
First Posted : January 6, 2003
Last Update Posted : November 1, 2021
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
HIV Infections Hepatitis B Drug: Telbivudine Drug: Lamivudine Drug: Efavirenz Drug: Didanosine Drug: Abacavir Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. HBV viral loads [ Time Frame: At Study entry, Week 24 and Week 48 ]
  2. Safety and tolerability of telbivudine [ Time Frame: Throughout study ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051090


Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Chair: Patrick Lynch, M.D. Northwestern University
More Information
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Publications:

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00051090    
Other Study ID Numbers: A5167
10962 ( Registry Identifier: DAIDS ES )
ACTG A5167
First Posted: January 6, 2003    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
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:
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Hepatitis A
HIV Infections
Hepatitis B
Hepatitis
Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Lamivudine
Efavirenz
Abacavir
Didanosine
Telbivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors