HIV InfectionsPhase 3NCT00023153
Lamivudine and Adefovir to Treat Chronic Hepatitis B Infection in People With and Without HIV Infection
A Phase 3 study testing Adefovir Dipivoxil in people with HIV Infections and Chronic Hepatitis B, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will evaluate the safety and effectiveness of adefovir plus lamivudine for chronic hepatitis B infection in people with and without HIV infection. Lamuvidine, an FDA-approved treatment for hepatitis B infection, also works against HIV. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections, Chronic Hepatitis B
- What is being tested?
- Adefovir Dipivoxil
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Oct 2004
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Infection with HBV with HBV viral load greater than 1.0 x 10 (6) copies/mL by Roche assay at screen
- HIV infected or uninfected
- If HIV infected: CD4 greater than or equal to 100 and VL less than or equal to 10,000 at screen; No antiretroviral changes 12 weeks prior to entry and no anticipated changes 12 weeks into study.
- Have a physician(s) outside of NIH who will provide routine, as well as HIV (if applicable) and liver specific, care.
- Able to return to NIH for study visits
Show all 18Show fewer
- Receiving lamivudine at a dose of at least 100 mg qd for greater than or equal to one year prior to enrollment (with no dosing interruptions of greater than 1 month total in the previous year and no interruption in the 3 months prior to study entry)
- Serum creatinine less than 1.5 mg/dL
- 1.2 less than or equal to ALT (SGPT) less than or equal to 7 X ULN (current NIH lab values 49-287 U/L inclusive) at screen
- Direct bilirubin less than or equal to 1.0 mg/dL
- Serum phosphorus greater than or equal to 2.2 mg/dL (normal range NIH 2.3-4.3 mg/dL)
- Neutrophil count greater than or equal to 750 cells/mm(3)
- Platelets greater than or equal to 70,000/mm(3)
- INR less than or equal to 1.5
- Hemoglobin greater than or equal to 10 mg/dL
- If capable of pregnancy: use of effective contraception during study: effective contraception methods include abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap or sponge, or use of hormonal contraception. If HIV infected using hormonal contraception, must be receiving an anti-HIV regimen that will not alter the metabolism of hormonal contraception.
- Willing and able to provide written informed consent
- Willing to undergo hepatic biopsy at the start and end of study. The initial protocol biopsy will not be required if the subject can provide pathologic slides from a biopsy performed within six months of the History and Physical visit that are found by the Liver Disease Section and the NIH's pathologist to be adequate for this study.
Who cannot join
- Prior use of ADV, tenofovir, or cidofovir
- Decompensated cirrhosis:
- Child-Pugh Class B or C cirrhosis;
- Class A Score = 5 acceptable; Class A Score = 6 acceptable as long as not secondary to encephalopathy or ascites
- Active serious systemic infections other than HIV or HBV
- Liver disease caused by reasons other than hepatitis B e.g., HCV, HDV, Wilson's, hemochromatosis, autoimmune hepatitis (ANA greater than or equal to 3 EU) except history of drug-associated hepatitis with discontinuation of causative agent
Show all 24Show fewer
- History of encephalopathy, varices, heart failure, or ascites
- Current history of clinical pancreatitis
- New AIDS-defining event other than esophageal candidiasis diagnosed within 1 month prior to baseline
- Treatment with immunomodulator drugs (interleukins, corticosteriods for indications other than the treatment of adrenal insufficiency) in the 4 weeks prior to baseline. G-CSF and epoetin use are permitted.
- Anti-HBV therapy other than lamivudine (such as emtricitabine, lobucavir, entecavir, HBIG, clevudine, MCC-478) with the exception of interferon alpha, famciclovir or foscarnet that ended more than 12 weeks prior to screen.
- Hepatic mass suggestive of hepatocellular carcinoma
- Alpha fetoprotein greater than 200 ng/ml
- Evidence of gastrointestinal malabsorption or chronic nausea or vomiting
- Current alcohol or substance abuse that potentially could interfere with patient compliance
- Malignancy other than cutaneous Kaposi's sarcoma, skin cancer treated by resection or HPV-associated carcinoma in situ or Bowen's disease in the 5 years prior to enrollment
- History of clinically significant renal dysfunction within the previous 12 months prior to baseline
- Concomitant therapy with aminoglycosides, amphotericin B, cisplatinum, IV pentamidine, vancomycin, systemic chemotherapeutic agents, probenecid or other nephrotoxic agents
- Proteinuria (greater than or equal to 3+)
- Positive PCR test for hepatitis C
- Antibodies to hepatitis D (delta hepatitis)
- Pregnancy or breast-feeding. Pregnancy test must be negative within two weeks prior to dosing with adefovir or placebo.
- History of organ or bone marrow transplantation
- Any systemic illness that will make it unlikely that the subject will be able to return to NIH for the required study visits
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
About this study
Official title: Studies of the Addition of Adefovir Dipivoxil to Lamivudine for the Treatment of Chronic Hepatitis B: A Randomized, Double-Blind, Placebo Controlled Study in HIV-Infected Patients and an Open-Label Study in HIV-Negative Subjects
This study will evaluate the safety and effectiveness of adefovir plus lamivudine for chronic hepatitis B infection in people with and without HIV infection. Lamuvidine, an FDA-approved treatment for hepatitis B infection, also works against HIV. In some patients, the hepatitis B virus (HBV) continues to reproduce despite lamivudine treatment. Adefovir is an experimental drug that inhibits HBV replication and may work against some strains of the virus that have become resistant to lamivudine.
Patients 21 years of age or older with active hepatitis B infection despite treatment with lamivudine for at least 1 year may be eligible for this 48-week study. Patients both with or without HIV infection may participate. Candidates will be screened with a medical history, blood and urine tests, liver ultrasound exam, electrocardiogram (EKG) and chest X-ray.
Read more
Participants will have a physical examination, review of their medical history, blood tests, and a 24-hour urine collection. They will be admitted to the hospital for a liver biopsy to determine if they can receive the study drug. For this procedure, the patient is given a sedative for relaxation. The skin over the biopsy is numbed with an anesthetic and the biopsy needle is passed rapidly into and out of the liver to collect a tissue specimen. Patients are monitored in the hospital overnight for possible complications. After discharge, they return home and begin taking the study medications.
Patients will be randomized to two treatment groups. One group will take 10 milligrams/day of adefovir by mouth, and the other will take a placebo-a lookalike pill with no active ingredient. Both groups will also take 150 mg lamivudine by mouth and L-carnitine pills or liquid. Patients with HIV infection will continue to take antiretroviral therapy as well.
Patients will be followed in the clinic at study weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 for blood and urine tests to determine the safety of the drug and to evaluate the response to treatment. On week 48, a repeat 24-hour urine test and repeat liver biopsy will be done. At the end of the 48 weeks, patients may continue to receive adefovir for another 48 weeks and possibly longer. All those who participate in this extension phase will receive active adefovir, regardless of whether they had previously taken adefovir or placebo.
All patients will have the option to enroll in a separate study to examine the levels of HBV (and levels of HIV in HIV-infected patients) in the blood immediately after starting treatment and to determine if these initial levels can predict later outcome. This involves seven additional visits, for which participants will be compensated. At these visits, blood will be drawn on study days 0 (before starting drug treatment), 1, 3, 5, 7, 10 and 21 for HIV and HBV viral loads and specialized immunology tests.
Read the detailed description
This clinical trial examines the addition of adefovir dipivoxil to a lamivudine regimen for treating chronic hepatitis B infection. Two patient populations will be separately recruited: HIV-infected (40 subjects) and HIV-uninfected (20 subjects). HIV-infected patients will be enrolled in a randomized, placebo controlled study of the safety and efficacy of the addition of adefovir to lamivudine for the treatment of chronic hepatitis B in subjects with a hepatitis B virus (HBV) viral load of at least one million copies/mL despite at least one year of lamivudine therapy. A similar population of HIV-uninfected subjects will be treated with open-label adefovir 10 mg daily for one year. These HIV-negative subjects will serve as a control group for immunological comparisons to the HIV-positive group treated with adefovir. HIV-infected subjects will be randomly allocated to receive adefovir 10 mg daily for one year or matching placebo. At the end of one year, HIV-infected patients may choose to receive open-label adefovir, and HIV-uninfected patients will have the option of continuing open-label drug if they are responding to treatment. Patients may not have decompensated cirrhosis or other causes of liver disease such as hepatitis C. Liver biopsies are performed prior to study and at the end of one year. HIV-positive subjects whose liver biopsy demonstrates cirrhosis will not be randomized but will be treated with open-label adefovir 10 mg daily. The purpose of the study is to evaluate the safety and efficacy of lamivudine plus adefovir as compared with continued lamivudine in HIV-infected patients, to compare responses between HIV-uninfected and HIV-infected subjects, and to obtain specimens for studies of immune responses to HBV. HIV-infected patients will receive lamivudine 150 mg bid plus adefovir 10 mg qd (or placebo) and HIV-uninfected subjects will receive lamivudine 100 mg qd plus adefovir 10 mg qd. L-carnitine supplementation will be used only if low serum carnitine levels are documented. Additionally, patients will have the option of enrolling in a sub-study assessing the kinetics of viral load response to study drug. Specimens will be stored for possible future determination of adefovir levels and use in evaluating HBV and HIV resistance to adefovir. Patients discontinuing study drug and not initiating a commerically available anti-HBV medication (including adefovir) will be monitored for safety for at least an additional 24 weeks. The primary study endpoint will be a comparison of the absolute HBV viral load at Week 48 between the placebo and adefovir HIV-positive patient groups, and for the HIV-negative population, the comparison of absolute HBV viral at Week 48 versus baseline. Secondary endpoints include safety, liver pathology, and transaminase level. Adefovir will be discontinued for toxicity; there will be no dose reduction. A DSMB will oversee the trial for toxicity.
- Conditions
- HIV Infections, Chronic Hepatitis B
- Being tested
- Adefovir Dipivoxil
- Keywords
- Drug Resistance, Viral Load, Liver, Immunology, Liver Histology, Hepatitis B, HBV, HIV
- Medical subject headings
- HIV Infections, Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adefovir DipivoxilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2001 (estimated)
- Study startAug 2001
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 3
- Primary purpose
- Treatment
- Enrolment
- 100 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023153
- Sponsor's protocol ID
- 010239
- Other IDs
- 01-I-0239
- Status last verified
- Oct 2004
- First submitted
- 24 Aug 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Benhamou Y, Katlama C, Lunel F, Coutellier A, Dohin E, Hamm N, Tubiana R, Herson S, Poynard T, Opolon P. Effects of lamivudine on replication of hepatitis B virus in HIV-infected men. Ann Intern Med. 1996 Nov 1;125(9):705-12. doi: 10.7326/0003-4819-125-9-199611010-00001.
PubMed 8929003Dienstag JL, Schiff ER, Wright TL, Perrillo RP, Hann HW, Goodman Z, Crowther L, Condreay LD, Woessner M, Rubin M, Brown NA. Lamivudine as initial treatment for chronic hepatitis B in the United States. N Engl J Med. 1999 Oct 21;341(17):1256-63. doi: 10.1056/NEJM199910213411702.
PubMed 10528035Lau DT, Khokhar MF, Doo E, Ghany MG, Herion D, Park Y, Kleiner DE, Schmid P, Condreay LD, Gauthier J, Kuhns MC, Liang TJ, Hoofnagle JH. Long-term therapy of chronic hepatitis B with lamivudine. Hepatology. 2000 Oct;32(4 Pt 1):828-34. doi: 10.1053/jhep.2000.17912.
PubMed 11003630
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of the Addition of Adefovir Dipivoxil to Lamivudine for the Treatment of Chronic Hepatitis B: A Randomized, Double-Blind, Placebo Controlled Study in HIV-Infected Patients and an Open-Label Study in HIV-Negative Subjects
- ClinicalTrials.gov ID
- NCT00023153
- Acronym / sponsor ID
- 010239
- Conditions
- HIV Infections, Chronic Hepatitis B
- Keywords
- Drug Resistance, Viral Load, Liver, Immunology, Liver Histology, Hepatitis B, HBV, HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2001
- Study completion
- Oct 2004
- First posted
- 27 Aug 2001 (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 safety and effectiveness of adefovir plus lamivudine for chronic hepatitis B infection in people with and without HIV infection. Lamuvidine, an FDA-approved treatment for hepatitis B infection, also works against HIV. In some patients, the hepatitis B virus (HBV) continues to reproduce despite lamivudine treatment. Adefovir is an experimental drug that inhibits HBV replication and may work against some strains of the virus that have become resistant to lamivudine.
Patients 21 years of age or older with active hepatitis B infection despite treatment with lamivudine for at least 1 year may be eligible for this 48-week study. Patients both with or without HIV infection may participate. Candidates will be screened with a medical history, blood and urine tests, liver ultrasound exam, electrocardiogram (EKG) and chest X-ray.
Participants will have a physical examination, review of their medical history, blood tests, and a 24-hour urine collection. They will be admitted to the hospital for a liver biopsy to determine if they can receive the study drug. For this procedure, the patient is given a sedative for relaxation. The skin over the biopsy is numbed with an anesthetic and the biopsy needle is passed rapidly into and out of the liver to collect a tissue specimen. Patients are monitored in the hospital overnight for possible complications. After discharge, they return home and begin taking the study medications.
Patients will be randomized to two treatment groups. One group will take 10 milligrams/day of adefovir by mouth, and the other will take a placebo-a lookalike pill with no active ingredient. Both groups will also take 150 mg lamivudine by mouth and L-carnitine pills or liquid. Patients with HIV infection will continue to take antiretroviral therapy as well.
Patients will be followed in the clinic at study weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44 for blood and urine tests to determine the safety of the drug and to evaluate the response to treatment. On week 48, a repeat 24-hour urine test and repeat liver biopsy will be done. At the end of the 48 weeks, patients may continue to receive adefovir for another 48 weeks and possibly longer. All those who participate in this extension phase will receive active adefovir, regardless of whether they had previously taken adefovir or placebo.
All patients will have the option to enroll in a separate study to examine the levels of HBV (and levels of HIV in HIV-infected patients) in the blood immediately after starting treatment and to determine if these initial levels can predict later outcome. This involves seven additional visits, for which participants will be compensated. At these visits, blood will be drawn on study days 0 (before starting drug treatment), 1, 3, 5, 7, 10 and 21 for HIV and HBV viral loads and specialized immunology tests.
Detailed description
This clinical trial examines the addition of adefovir dipivoxil to a lamivudine regimen for treating chronic hepatitis B infection. Two patient populations will be separately recruited: HIV-infected (40 subjects) and HIV-uninfected (20 subjects). HIV-infected patients will be enrolled in a randomized, placebo controlled study of the safety and efficacy of the addition of adefovir to lamivudine for the treatment of chronic hepatitis B in subjects with a hepatitis B virus (HBV) viral load of at least one million copies/mL despite at least one year of lamivudine therapy. A similar population of HIV-uninfected subjects will be treated with open-label adefovir 10 mg daily for one year. These HIV-negative subjects will serve as a control group for immunological comparisons to the HIV-positive group treated with adefovir. HIV-infected subjects will be randomly allocated to receive adefovir 10 mg daily for one year or matching placebo. At the end of one year, HIV-infected patients may choose to receive open-label adefovir, and HIV-uninfected patients will have the option of continuing open-label drug if they are responding to treatment. Patients may not have decompensated cirrhosis or other causes of liver disease such as hepatitis C. Liver biopsies are performed prior to study and at the end of one year. HIV-positive subjects whose liver biopsy demonstrates cirrhosis will not be randomized but will be treated with open-label adefovir 10 mg daily. The purpose of the study is to evaluate the safety and efficacy of lamivudine plus adefovir as compared with continued lamivudine in HIV-infected patients, to compare responses between HIV-uninfected and HIV-infected subjects, and to obtain specimens for studies of immune responses to HBV. HIV-infected patients will receive lamivudine 150 mg bid plus adefovir 10 mg qd (or placebo) and HIV-uninfected subjects will receive lamivudine 100 mg qd plus adefovir 10 mg qd. L-carnitine supplementation will be used only if low serum carnitine levels are documented. Additionally, patients will have the option of enrolling in a sub-study assessing the kinetics of viral load response to study drug. Specimens will be stored for possible future determination of adefovir levels and use in evaluating HBV and HIV resistance to adefovir. Patients discontinuing study drug and not initiating a commerically available anti-HBV medication (including adefovir) will be monitored for safety for at least an additional 24 weeks. The primary study endpoint will be a comparison of the absolute HBV viral load at Week 48 between the placebo and adefovir HIV-positive patient groups, and for the HIV-negative population, the comparison of absolute HBV viral at Week 48 versus baseline. Secondary endpoints include safety, liver pathology, and transaminase level. Adefovir will be discontinued for toxicity; there will be no dose reduction. A DSMB will oversee the trial for toxicity.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Age greater than or equal to 18 years
- Infection with HBV with HBV viral load greater than 1.0 x 10 (6) copies/mL by Roche assay at screen
- HIV infected or uninfected
- If HIV infected: CD4 greater than or equal to 100 and VL less than or equal to 10,000 at screen; No antiretroviral changes 12 weeks prior to entry and no anticipated changes 12 weeks into study.
- Have a physician(s) outside of NIH who will provide routine, as well as HIV (if applicable) and liver specific, care.
Key exclusion criteria (24 listed)
- Prior use of ADV, tenofovir, or cidofovir
- Child-Pugh Class B or C cirrhosis;
- Class A Score = 5 acceptable; Class A Score = 6 acceptable as long as not secondary to encephalopathy or ascites
- Active serious systemic infections other than HIV or HBV
- Liver disease caused by reasons other than hepatitis B e.g., HCV, HDV, Wilson's, hemochromatosis, autoimmune hepatitis (ANA greater than or equal to 3 EU) except history of drug-associated hepatitis with discontinuation of causative agent
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 |
|---|---|---|
| Adefovir Dipivoxil | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8929003Benhamou Y, Katlama C, Lunel F, Coutellier A, Dohin E, Hamm N, Tubiana R, Herson S, Poynard T, Opolon P. Effects of lamivudine on replication of hepatitis B virus in HIV-infected men. Ann Intern Med. 1996 Nov 1;125(9):705-12. doi: 10.7326/0003-4819-125-9-199611010-00001.
- Background: PubMed 10528035Dienstag JL, Schiff ER, Wright TL, Perrillo RP, Hann HW, Goodman Z, Crowther L, Condreay LD, Woessner M, Rubin M, Brown NA. Lamivudine as initial treatment for chronic hepatitis B in the United States. N Engl J Med. 1999 Oct 21;341(17):1256-63. doi: 10.1056/NEJM199910213411702.
- Background: PubMed 11003630Lau DT, Khokhar MF, Doo E, Ghany MG, Herion D, Park Y, Kleiner DE, Schmid P, Condreay LD, Gauthier J, Kuhns MC, Liang TJ, Hoofnagle JH. Long-term therapy of chronic hepatitis B with lamivudine. Hepatology. 2000 Oct;32(4 Pt 1):828-34. doi: 10.1053/jhep.2000.17912.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adefovir Dipivoxil in people with HIV Infections and Chronic Hepatitis B, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 18 inclusion and 24 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: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00023153, which also lists 3 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 4 Mar 2008.