Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients
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ClinicalTrials.gov Identifier: NCT00132210 |
Recruitment Status :
Completed
First Posted : August 19, 2005
Last Update Posted : October 21, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C HIV Infections | Drug: pegylated interferon | Phase 4 |
Background:HIV-infected individuals are at higher risk of developing a chronic course of hepatitis C after infection. Moreover, chronic hepatitis C is less well treatable in HIV-Coinfected than in hepatitis C monoinfected patients. There is basic research and clinical data on hepatitis C mono-infection supporting high sustained response rates of hepatitis C when treatment is started in the acute phase of infection.
Aim of the study: To determine whether pegylated interferon therapy is effective to treat acute hepatitis C infection in HIV-coinfected individuals.
Methods: Prospective, open-label, historical controlled trial. Eligible subjects are treated over 24 weeks with a pegylated interferon at standard dose. Weight-adjusted ribavirin comedication is recommended for HCV-genotypes 1 and 4. Treatment will be withheld for 12 weeks in order to allow spontaneous resolution in subjects with clinical symptomatic hepatitis C infection.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients |
Study Start Date : | September 2002 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | June 2010 |

- Drug: pegylated interferon
Pegylated interferon alfa-2a or -2b in standard dosage Ribavirin in case of genotype 1 or 4 at 1000 or 1200 mg/d according to body weight ist recommended.Other Names:
- Pegasys
- PegIntron
- Copegus
- Rebetol
- Negative hepatitis C ribonucleic acid (HCV-RNA) in peripheral serum [ Time Frame: Week 24 ]
- Normal liver enzymes [ Time Frame: Week 24 ]
- Negative HCV-RNA [ Time Frame: Week 12 and 48 ]
- Normal liver enzymes [ Time Frame: Week 12 and 48 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Documented acute hepatitis C infection with detectable HCV-RNA (PCR-assay) and elevated serum alanine transferase (ALT) levels. An acute infection is defined by fulfilling two of the following 3 criteria within the preceding four months:
- known or suspected exposure to HCV,
- documented seroconversion to positivity for antibodies against HCV,
- a serum alanine transferase (ALT) level of more than 350 U/l with a documented normal level during the year before infection.
- Documented HIV-infection
- CD4 cells > 300 /µl
- Ability to understand and sign a written consent form
- Women of child-bearing age: negative pregnancy test
Exclusion Criteria:
- Autoimmune hepatitis or other autoimmune disease
- Decompensated liver disease
- Decompensated renal disease, i.e. creatinine clearance < 50 ml/min, according to Cockcroft-Gault
- Acute or chronic hepatitis B infection
- Acute infection with hepatitis A or other hepatotropic viruses
- New AIDS defining event less than 1 month prior to enrolment
- Malignancy other than cutaneous kaposi sarcoma treated with systemic chemo-therapy
- History of severe psychiatric conditions, in particular severe depression
- History of seizures
- History of organ transplantation
- Thyroid disease not medically compensable
- Severe heart disease
- Severe retinopathy
- Known allergy to the study drug or one of the galenic compounds
- Hypersensitivity to interferon a
- Thrombocytes < 90 G/l, neutrophils < 1.5 G/l, hemoglobin must not be < 12g/dl (female) or < 13 g/dl (male)
- Treatment with corticosteroids less than 3 months prior to enrolment
- Alcohol abuse or use of other recreational drugs
- Older than 65 years of age, younger than 18 years of age
- Pregnancy, breast-feeding

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): NCT00132210
Germany | |
Practice Hintsche | |
Berlin, Germany, 10117 | |
Practice Bieniek | |
Berlin, Germany, 10243 | |
Practice Dupke/Carganico/Baumgarten | |
Berlin, Germany, 10439 | |
Practice Schranz | |
Berlin, Germany, 10627 | |
Practice Freiwald/Rausch | |
Berlin, Germany, 10777 | |
Practice Jessen | |
Berlin, Germany, 10777 | |
Practice Kluschke | |
Berlin, Germany, 12047 | |
Ärzteforum Seestraße | |
Berlin, Germany, 13347 | |
Practice Center Kaiserdamm | |
Berlin, Germany, 14057 | |
Medical Department I, University Hospital, Bonn University | |
Bonn, Germany, 53127 | |
Practice St. Georg | |
Hamburg, Germany, 20099 | |
Practice Fenske | |
Hamburg, Germany, 20146 | |
Practice Linnig | |
Hamburg, Germany, 20359 | |
Practice Trein | |
Stuttgart, Germany, 70197 |
Study Director: | Jürgen K Rockstroh, MD, PhD | Medical Department I, University Hospital, Bonn University, Germany | |
Principal Investigator: | Martin Vogel, MD | Medical Department I, University Hospital, Bonn University |
Other Publications:
Responsible Party: | Jürgen K. Rockstroh, Bonn University |
ClinicalTrials.gov Identifier: | NCT00132210 |
Other Study ID Numbers: |
BN-102/02 |
First Posted: | August 19, 2005 Key Record Dates |
Last Update Posted: | October 21, 2010 |
Last Verified: | November 2009 |
acute hepatitis C HIV pegylated interferon |
Infection Communicable Diseases Hepatitis A Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferons Antineoplastic Agents Antiviral Agents Anti-Infective Agents |