HIV Infection Clinical Trial
Official title:
Adefovir Dipivoxil for the Treatment of Hepatitis B in Human Immunodeficiency Virus Infected Patients With Decompensated Hepatitis B Liver Disease and a Hepatitis B Viral Load of at Least 1.0 X 10(6) (Copies/mL) Despite 52 Weeks of Lamivudine Therapy
This study will evaluate the safety and effectiveness of adding the experimental drug
adefovir dipivoxil to lamivudine for treating hepatitis B virus (HBV) infection in
HIV-infected patients with liver cirrhosis. Adefovir inhibits HBV by interfering with
replication of the virus's genetic material. In some people, the drug has been active
against strains of HBV that are resistant to lamivudine; it may also have some activity
against HIV.
HIV-infected patients 21 years of age and older with chronic hepatitis B infection and liver
cirrhosis who have received lamivudine treatment for at least 1 year may be eligible for
this 48-week study. Candidates will be screened with a complete medical history, blood tests
and a 24-hour urine collection. Blood tests include HLA typing (a test of genetic markers on
white blood cells that permit specialized immunology studies). Within 4 weeks, candidates
who appear eligible for the study will have a physical examination and medical history, an
abdominal ultrasound (imaging test using sound waves) to check for cancer of the liver,
chest X-ray and electrocardiogram (EKG). Blood and urine tests will also be done, and women
who can become pregnant will have a pregnancy test.
Patients who meet the study criteria and decide to participate will then start treatment
with one 10-mg adefovir pill per day by mouth. In addition, patients will continue to take
all other medications prescribed by their doctor. Follow-up clinic visits will be scheduled
as follows:
- Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for specialized immunology tests and
to measure blood levels of HIV and HBV.
- Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 - Blood and urine (single sample)
tests will be done to determine the side effects of adefovir and its effect on the HBV
infection.
- Week 48 or early termination (end of study) - Blood tests (including tests for
hepatitis C and D), abdominal ultrasound and a 24-hour urine collection to evaluate
kidney function will be done.
- Monthly visits beyond week 48 - Based on the HBV response to treatment and the
availability of the drug from the sponsor, patients may be offered to extend their
treatment with adefovir. Those who continue will have monthly follow-up visits for
blood and urine (single sample) tests.
Patients co-infected with human immunodeficiency virus (HIV) and hepatitis B virus (HBV) who have advanced liver disease (decompensated cirrhosis by Child-Pugh score and no known cause of hepatitis other than HBV), a HBV viral load of at least 1 million copies/mL blood, and at least one year of therapy with lamivudine will be treated with open-label adefovir dipivoxil 10 mg daily and lamivudine 150 mg bid to evaluate the safety and efficacy of this regimen in this patient group and to obtain specimens for studies of immune responses to HBV in HIV-infected patients. Additionally the kinetics of viral load response to adefovir will be assessed. Specimens will be stored for possible use in evaluating HBV and HIV resistance to adefovir. L-carnitine supplementation will be used only if low serum carnitine levels are documented. Patients will be followed for HBV viral load response to adefovir for 48 weeks with possible extension. The primary study endpoints will be HBV viral load at week 24 (per-protocol patients) and DAVG at week 24 (intent-to-treat patients). Adefovir will be discontinued for toxicity; there will be no dose reduction. Up to 30 subjects will be enrolled. ;
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02135419 -
Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions
|
Phase 3 | |
Active, not recruiting |
NCT02663856 -
My Smart Age With HIV: Smartphone Self-assessment of Frailty
|
||
Completed |
NCT02846402 -
Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda
|
N/A | |
Completed |
NCT02659306 -
Metformin Immunotherapy in HIV Infection
|
Phase 1 | |
Terminated |
NCT02743598 -
Liraglutide for HIV-associated Neurocognitive Disorder
|
Phase 4 | |
Completed |
NCT02921516 -
Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings
|
N/A | |
Completed |
NCT02663869 -
Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
|
||
Completed |
NCT02564341 -
Targeting Effective Analgesia in Clinics for HIV - Intervention
|
N/A | |
Active, not recruiting |
NCT02302950 -
A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas
|
N/A | |
Terminated |
NCT02109224 -
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
|
Phase 1 | |
Terminated |
NCT01902186 -
Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir
|
Phase 4 | |
Completed |
NCT01852942 -
Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
|
Phase 2 | |
Completed |
NCT01830595 -
Lactoferrin Treatment in HIV Patients
|
Phase 2 | |
Completed |
NCT02269605 -
Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment
|
Phase 1 | |
Completed |
NCT02118168 -
Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002
|
N/A | |
Completed |
NCT02527135 -
Text Messaging to Improve HIV Testing Among Young Women in Kenya
|
N/A | |
Completed |
NCT02525146 -
Birmingham Access to Care Study
|
N/A | |
Completed |
NCT01946217 -
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
|
N/A | |
Active, not recruiting |
NCT02602418 -
Neural Correlates of Working Memory Training for HIV Patients
|
N/A | |
Completed |
NCT01680094 -
Safety and Effect of The HDAC Inhibitor Panobinostat on HIV-1 Expression in Patients on Suppressive HAART
|
Phase 1/Phase 2 |