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

Primary Purpose

HIV Infections, Hepatitis B

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telbivudine
Lamivudine
Efavirenz
Didanosine
Abacavir
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Hepatitis B, Antiretroviral Therapy, Highly-Active, HIV Infections, Lamivudine, Reverse Transcriptase Inhibitors, Antiviral Agents, Drug Therapy, Combination, Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    A

    Arm Description

    All eligible study participants

    Outcomes

    Primary Outcome Measures

    HBV viral loads
    Safety and tolerability of telbivudine

    Secondary Outcome Measures

    Safety and tolerability of HAART
    Change in ALT level
    HBV genetic mutation status at HBV virologic failure
    HIV viral load
    HBV viral load and hepatic transaminase concentrations

    Full Information

    First Posted
    January 3, 2003
    Last Updated
    October 28, 2021
    Sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00051090
    Brief Title
    Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients With Both HBV and HIV
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)

    4. Oversight

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections, Hepatitis B
    Keywords
    Hepatitis B, Antiretroviral Therapy, Highly-Active, HIV Infections, Lamivudine, Reverse Transcriptase Inhibitors, Antiviral Agents, Drug Therapy, Combination, Treatment Naive

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    All eligible study participants
    Intervention Type
    Drug
    Intervention Name(s)
    Telbivudine
    Intervention Description
    Administered orally at a daily dosage of 600 mg for a period of 48 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Lamivudine
    Intervention Description
    Administered orally at a total daily dosage of 300 mg for Weeks 24-48
    Intervention Type
    Drug
    Intervention Name(s)
    Efavirenz
    Intervention Description
    Administered orally at a daily dose of 600 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Didanosine
    Intervention Description
    Administered orally at a total dosage of either 400 mg or 250 mg determined by individual weight
    Intervention Type
    Drug
    Intervention Name(s)
    Abacavir
    Intervention Description
    Administered orally twice daily in doses of 300 mg
    Primary Outcome Measure Information:
    Title
    HBV viral loads
    Time Frame
    At Study entry, Week 24 and Week 48
    Title
    Safety and tolerability of telbivudine
    Time Frame
    Throughout study
    Secondary Outcome Measure Information:
    Title
    Safety and tolerability of HAART
    Time Frame
    Throughout study
    Title
    Change in ALT level
    Time Frame
    Throughout study
    Title
    HBV genetic mutation status at HBV virologic failure
    Time Frame
    Throughout study
    Title
    HIV viral load
    Time Frame
    At Study entry, Weeks 24, 48, and 60
    Title
    HBV viral load and hepatic transaminase concentrations
    Time Frame
    At Week 60

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patrick Lynch, M.D.
    Organizational Affiliation
    Northwestern University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11153671
    Citation
    den Brinker M, Wit FW, Wertheim-van Dillen PM, Jurriaans S, Weel J, van Leeuwen R, Pakker NG, Reiss P, Danner SA, Weverling GJ, Lange JM. Hepatitis B and C virus co-infection and the risk for hepatotoxicity of highly active antiretroviral therapy in HIV-1 infection. AIDS. 2000 Dec 22;14(18):2895-902. doi: 10.1097/00002030-200012220-00011.
    Results Reference
    background
    PubMed Identifier
    10632283
    Citation
    Sulkowski MS, Thomas DL, Chaisson RE, Moore RD. Hepatotoxicity associated with antiretroviral therapy in adults infected with human immunodeficiency virus and the role of hepatitis C or B virus infection. JAMA. 2000 Jan 5;283(1):74-80. doi: 10.1001/jama.283.1.74.
    Results Reference
    background
    PubMed Identifier
    11786975
    Citation
    Sulkowski MS, Thomas DL, Mehta SH, Chaisson RE, Moore RD. Hepatotoxicity associated with nevirapine or efavirenz-containing antiretroviral therapy: role of hepatitis C and B infections. Hepatology. 2002 Jan;35(1):182-9. doi: 10.1053/jhep.2002.30319.
    Results Reference
    background
    PubMed Identifier
    10534354
    Citation
    Benhamou Y, Bochet M, Thibault V, Di Martino V, Caumes E, Bricaire F, Opolon P, Katlama C, Poynard T. Long-term incidence of hepatitis B virus resistance to lamivudine in human immunodeficiency virus-infected patients. Hepatology. 1999 Nov;30(5):1302-6. doi: 10.1002/hep.510300525.
    Results Reference
    background

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

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