Tenofovir in HIV/HBV Coinfection (NCT00192595) | Clinical Trial Compass
CompletedPhase 4
Tenofovir in HIV/HBV Coinfection
Australia, Thailand36 participantsStarted 2004-01
Plain-language summary
The purpose of the study is to compare the effectiveness of 3 different treatment regimens in reducing or clearing the Hepatitis B Virus in patients infected with HIV and Hepatitis B (co-infection)
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent
* Documented HIV infection (positive serology for HIV-1 and detectable HIV-1 RNA)
* Age 18 - 70 years
* HBV DNA \> 105 copies/ml
* HBsAg positive \>6 months or HBsAg positive and anti HB core IgM negative
* Creatinine \<= 2.0mg/dl (\<= 0.2 mmol/L)
* Platelet count \>= 50,000/mm
* HIV-1 antiretroviral therapy naïve
* No prior exposure to anti-HBV agents (LAM, adefovir, TDF) although prior IFN treatment allowed
Exclusion Criteria:
* HCV-RNA positive or Anti-HAV IgM positive
* Acute hepatitis (serum ALT \> 1000 U/L)
* Active opportunistic infection
* Other causes of chronic liver disease identified (autoimmune hepatitis, hemochromatosis, Wilsons disease, alfa-1-antitrypsin deficiency)
* Concurrent malignancy requiring cytotoxic chemotherapy
* Decompensated or Child's C cirrhosis
* Alfa-fetoprotein (AFP) \> 3X ULN (unless negative CT scan or MRI within 3 months of entry date)
* Pregnancy or lactation
* Any other condition which in the opinion of the investigator might interfere with compliance or outcome of the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group