TerminatedPhase 3

Efficacy and Safety of PegIFN +/- FTC / TDF to Treat Chronic Hepatitis B in HIV-Coinfected Patients

Stopped: Lack of accrual

Germany2 participantsStarted 2004-09

Plain-language summary

The efficacy of pegylated interferons in the treatment of chronic hepatitis B has shown superior results to standard of care in patients only infected with hepatitis B. The efficacy of pegylated interferon for the treatment of chronic hepatitis B in HIV-coinfected patients is not known at present. The purpose of this study is to evaluate the efficacy of pegylated interferon in the treatment of chronic hepatitis B in HIV-infected individuals. Apart from evaluating the efficacy of pegylated interferon therapy in this setting as such, i.e. in patients without present or future need of highly active antiretroviral therapy (HAART) for HIV-infection, there is a second purpose of this study, to investigate whether combination treatment of HBV-infection may be superior to pegylated interferon therapy alone. Therefore patients without need of HAART are offered pegylated interferon alfa-2a over 48 weeks. Patients who require HAART are offered emtricitabine / tenofovir DF containing HAART over 72 weeks PLUS pegylated interferon alfa-2a over 48 weeks vs. emtricitabine / tenofovir DF containing HAART over 72 weeks WITHOUT pegylated interferon-alfa-2a.

Who can participate

Age range

18 Years – 65 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: * Documented chronic hepatitis B infection (\> 6 months) with detectable HBV DNA \> 5x100000 copies/ml (PCR-Assay) on two separate occasions * HBe-Ag positive, anti-HBe negative * HBs-Ag positive, anti-HBs negative * a liver biopsy within the last 12 months prior to screening consistent with chronic hepatitis B * Documented HIV-infection * CD4-cell count \> 200 cells/µl * Elevated serum ALT \> ULN but £ 10X ULN as determined by two abnormal values taken \>14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained during the screening period * Serum-creatinine clearance \> 70 ml/min, according to Cockcroft-Gault * Anorganic phosphate \> 0,65 mmol/l (2,0 mg/dl) * Neutrophils above 1.5 G/l, Hb above 11.5 g/dl (females) or 12.5 g/dl(males), thrombocytes above 90 G/l * Ability to understand and sign a written consent form Exclusion Criteria: * Older than 65 years of age, younger than 18 years of age * Pregnancy, lactating women * Concomitant / prior medication / hypersensitivity to study medication * Prior use of antiretroviral therapy in particular adefovir dipivoxil, tenofovir DF, lamivudine, emtricitabine, or interferon * Treatment with interleukin 2 or corticosteroids less than 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study. * Currently receiving investigational agents unless approved by the study coordinator * …

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

Efficacy: HBeAg seroconversion (HBeAg loss and presence of anti HBe) ; intent to treat analysis.

Timeframe: week 48 and 72

Safety: study discontinuation due to adverse events; intent to treat analysis.

Timeframe: week 48

Trial details

NCT IDNCT00221286

SponsorUniversity Hospital, Bonn

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-01

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