Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients With Both HBV and HIV
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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 |
- 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 ]
- 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 |
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 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:
|
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis B Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Liver Diseases |
Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Hepadnaviridae Infections DNA Virus Infections Didanosine Lamivudine Reverse Transcriptase Inhibitors Efavirenz Abacavir Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on February 28, 2013
