HIV InfectionsNCT00051090
Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients With Both HBV and HIV
A study testing Telbivudine, Lamivudine and Efavirenz in people with HIV Infections and Hepatitis B, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Hepatitis B
- What is being tested?
- Telbivudine, Lamivudine and Efavirenz
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
About this study
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
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).
Read the 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.
- Conditions
- HIV Infections, Hepatitis B
- Being tested
- Telbivudine, Lamivudine, Efavirenz, Didanosine, Abacavir
- Keywords
- Hepatitis B, Antiretroviral Therapy, Highly-Active, HIV Infections, Lamivudine, Reverse Transcriptase Inhibitors, Antiviral Agents, Drug Therapy, Combination, Treatment Naive
- Medical subject headings
- HIV Infections, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelbivudineDrug
Administered orally at a daily dosage of 600 mg for a period of 48 weeks
LamivudineDrug
Administered orally at a total daily dosage of 300 mg for Weeks 24-48
EfavirenzDrug
Administered orally at a daily dose of 600 mg
DidanosineDrug
Administered orally at a total dosage of either 400 mg or 250 mg determined by individual weight
AbacavirDrug
Administered orally twice daily in doses of 300 mg
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | All eligible study participants Receives: Drug: Telbivudine; Drug: Lamivudine; Drug: Efavirenz; Drug: Didanosine; Drug: Abacavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV viral loads
Measured: At Study entry, Week 24 and Week 48
Safety and tolerability of telbivudine
Measured: Throughout study
Secondary outcomes (5)
Safety and tolerability of HAART
Measured: Throughout study
Change in ALT level
Measured: Throughout study
HBV genetic mutation status at HBV virologic failure
Measured: Throughout study
HIV viral load
Measured: At Study entry, Weeks 24, 48, and 60
HBV viral load and hepatic transaminase concentrations
Measured: At Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2003 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Patrick Lynch, M.D., Study chair, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051090
- Sponsor's protocol ID
- A5167
- Other IDs
- 10962, ACTG A5167
- Status last verified
- Oct 2021
- First submitted
- 3 Jan 2003
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
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.
PubMed 11153671Sulkowski 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.
PubMed 10632283Sulkowski 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.
PubMed 11786975Benhamou 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.
PubMed 10534354
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00051090
- Acronym / sponsor ID
- A5167
- 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
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 6 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Telbivudine, Drug: Lamivudine, Drug: Efavirenz, Drug: Didanosine, Drug: AbacavirAll eligible study participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelbivudineAdministered orally at a daily dosage of 600 mg for a period of 48 weeks | Drug | A |
| LamivudineAdministered orally at a total daily dosage of 300 mg for Weeks 24-48 | Drug | A |
| EfavirenzAdministered orally at a daily dose of 600 mg | Drug | A |
| DidanosineAdministered orally at a total dosage of either 400 mg or 250 mg determined by individual weight | Drug | A |
| AbacavirAdministered orally twice daily in doses of 300 mg | Drug | A |
Primary outcome
HBV viral loads
Time frame: At Study entry, Week 24 and Week 48
Safety and tolerability of telbivudine
Time frame: Throughout study
5 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Background: PubMed 11153671den 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.
- Background: PubMed 10632283Sulkowski 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.
- Background: PubMed 11786975Sulkowski 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.
- Background: PubMed 10534354Benhamou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Lynch, M.D. study chair
Northwestern University
Questions about this trial
What is this clinical trial studying?
A study testing Telbivudine, Lamivudine and Efavirenz in people with HIV Infections and Hepatitis B, run by National Institute of Allergy and Infectious Diseases (NIAID).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBV viral loads (time frame: At Study entry, Week 24 and Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00051090, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.