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

NCT00051090 | Withdrawn

• 3 other identifiers: A516710962ACTG A5167
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

HIV Infections; Hepatitis B

Keywords

Hepatitis B; Antiretroviral Therapy, Highly-Active; HIV Infections; Lamivudine; Reverse Transcriptase Inhibitors; Antiviral Agents; Drug Therapy, Combination; Treatment Naive

Outcome Measures

Primary Outcomes (2)

• HBV viral loads

  At Study entry, Week 24 and Week 48

• Safety and tolerability of telbivudine

  Throughout study

Secondary Outcomes (5)

• Safety and tolerability of HAART

  Throughout study

• Change in ALT level

  Throughout study

• HBV genetic mutation status at HBV virologic failure

  Throughout study

• HIV viral load

  At Study entry, Weeks 24, 48, and 60

• HBV viral load and hepatic transaminase concentrations

  At Week 60

Study Arms (1)

A

EXPERIMENTAL

All eligible study participants

Drug: Telbivudine; Drug: Lamivudine; Drug: Efavirenz; Drug: Didanosine; Drug: Abacavir

Interventions

Telbivudine DRUG

Administered orally at a daily dosage of 600 mg for a period of 48 weeks

A

Lamivudine DRUG

Administered orally at a total daily dosage of 300 mg for Weeks 24-48

A

Efavirenz DRUG

Administered orally at a daily dose of 600 mg

A

Didanosine DRUG

Administered orally at a total dosage of either 400 mg or 250 mg determined by individual weight

A

Abacavir DRUG

Administered orally twice daily in doses of 300 mg

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Related Publications (4)

• 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.

  PMID: 11153671 BACKGROUND

• 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.

  PMID: 10632283 BACKGROUND

• 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.

  PMID: 11786975 BACKGROUND

• 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.

  PMID: 10534354 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Hepatitis B

Interventions

Telbivudine; Lamivudine; efavirenz; Didanosine; abacavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine; Dideoxynucleosides; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides

Study Officials

• Patrick Lynch, M.D.

  Northwestern University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2003
• First Posted: January 6, 2003
• Last Updated: November 1, 2021

Record last verified: 2021-10