HIV-HBV Co-Infection and Liver Disease
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00637429 |
|
Recruitment Status : Unknown
Verified March 2008 by Bayside Health.
Recruitment status was: Recruiting
First Posted : March 18, 2008
Last Update Posted : April 2, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Human immunodeficiency virus/Hepatitis B virus (HIV/HBV) co-infections are frequently observed due to shared routes of transmission, with reported figures indicating 6-9% of HIV-infected individuals in developed countries are chronically infected with HBV. HIV infection impacts on the natural progression of HBV infection, increasing levels of HBV replication and the risk of liver-associated mortality. Liver diseases associated with HBV are affected by the antiviral drugs used for HIV infection (toxic side effects), the current immune function in the patient, by improvements in the immune system brought about by control of the HIV infection, and by the development of resistance to the antiviral agents used for both the hepatitis B and the HIV infection. Co-infection with HBV increases the risk for hepatotoxicity in those individuals receiving highly active antiretroviral therapy (HAART) for their HIV infection.
This study will recruit patients who are co-infected with HIV and HBV, and are currently taking or who are about to commence HAART. The study cohort will include HIV-HBV co-infected individuals from the Alfred Hospital, the Royal Melbourne Hospital and high case load GP clinics who are referred to the Alfred Hospital.
The aim of the study is to investigate chronic hepatitis B and its impact on the progression of liver disease in HIV-infected persons receiving HAART.
This will be achieved by 6 monthly assessment with medical history, physical examination, bloods for markers of liver disease and hepatitis B activity and completion of questionnaires to measure adherence and alcohol use.
| Condition or disease |
|---|
| HIV Infections HIV-HBV Co-Infection |
| Study Type : | Observational |
| Estimated Enrollment : | 70 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) co-Infection and Liver Disease |
| Study Start Date : | November 2007 |
| Group/Cohort |
|---|
|
General Co-infection
Individuals with HIV infection and hepatitis B surface antigen positive results who are currently receiving or planning to commence HAART.
|
- To investigate the efficacy and sustainability of HBV-active HAART on hepatitis B suppression by measuring changes in the HBV DNA levels as well as monitoring ALT levels, CD4 counts and HBV serology results. [ Time Frame: 6 monthly assessment for 5 years ]
- The surveillance of antiviral resistance mutations that may develop in those individuals who are unable to sustain hepatitis B suppression [ Time Frame: 6 monthly assessment for 5 years ]
Biospecimen Retention: Samples Without DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 18 years of age and older
- HIV positive
- 2 positive Hepatitis B surface antigen results 6 months apart
- provision of informed consent
Exclusion Criteria:
- unable to provide informed consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637429
| Contact: Jennifer Audsley, PhD | +613 99030184 | jennifer.audsley@med.monash.edu.au |
| Australia, Victoria | |
| The Alfred Hospital | Recruiting |
| Melbourne, Victoria, Australia, 3004 | |
| Contact: Jennifer Audsley, PhD +613 99030184 jennifer.audsley@med.monash.edu.au | |
| Principal Investigator: Sharon Lewin | |
| Principal Investigator: Joe Sasadeusz | |
| Sub-Investigator: Jennifer Hoy | |
| Sub-Investigator: David Iser | |
| Sub-Investigator: Jennifer Audsley | |
| Principal Investigator: | Sharon R Lewin, MD, PhD | The Alfred Hospital, Melbourne & Monash University |
| Responsible Party: | Professor Sharon Lewin, The Alfred Hospital and Monash University |
| ClinicalTrials.gov Identifier: | NCT00637429 History of Changes |
| Other Study ID Numbers: |
ALF-263/06 |
| First Posted: | March 18, 2008 Key Record Dates |
| Last Update Posted: | April 2, 2008 |
| Last Verified: | March 2008 |
Additional relevant MeSH terms:
|
HIV Infections Infection Communicable Diseases Liver Diseases Coinfection Hepatitis B Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Digestive System Diseases Parasitic Diseases Hepadnaviridae Infections DNA Virus Infections Hepatitis, Viral, Human Hepatitis |