Status:
WITHDRAWN
Safety Study of Raltegravir in HIV/HCV Co-infected Patients
Lead Sponsor:
University Hospital, Bonn
Collaborating Sponsors:
Dr. Axel Baumgarten, Berlin
Dr. Christoph Stephan, Frankfurt/M
Conditions:
HIV
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Current European AIDS Clinical Society (EACS) guidelines for the treatment of HIV infection recommend a combination antiretroviral regimen composed of two nucleoside reverse transcriptase inhibitors p...
Eligibility Criteria
Inclusion
- HIV and Hepatitis C co-infected patients
- indication for HAART according to current German-Austrian guidelines
- HAART naive
- no primary NRTI / Integrase / PI associated resistance mutation according to the Stanford algorithm at screening; every patient MUST have a genotypic resistance assay prior baseline available (\< 6 months prior to baseline)
- women of childbearing age: negative pregnancy test
- ability to sign written informed consent
Exclusion
- advanced liver cirrhosis Child-Pugh B or C or decompensated liver disease
- Pegylated interferon / ribavirin or other anti-HCV therapy; planned anti-HCV therapy for duration of the study (48 weeks).
- acute or chronic hepatitis B infection
- acute hepatitis A or other hepatotropic virus infections
- any other chronic liver disease such as alcohol abuse or hemosiderosis
- use or planned use (for the duration of the study, 48 weeks) of rifampicin, St. John´s wort and drugs that are metabolized via the cytochrome P450 system with a narrow therapeutic PK-range such as astemizole, terfenadine, cisapride, pimozide, chinidin, bepridil, triazolam, midazolam, ergotamine, dihydroergotamin, ergometrine, methyl-ergometrine. FOR OTHER COMEDICATIONS please consult with the SPC of Raltegravir (Isentress®), Atazanavir (Reyataz®), Ritonavir (Norvir®), your hospital pharmacist, www.hiv-drug-interactions.org or the principal investigator in case of uncertainty.
- new AIDS defining event, except for Kaposi sarcoma, \< 1 months prior to screening
- malignancy, except for Kaposi sarcoma, with current radio- or chemotherapy
- history of organ transplantation
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01225705
Start Date
October 1 2010
End Date
August 1 2012
Last Update
June 3 2015
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Auguste Viktoria Hospital (AVK)
Berlin, Germany
2
Praxiszentrum Kaiserdamm
Berlin, Germany
3
Private Practice Dupke, Carganico, Baumgarten
Berlin, Germany
4
Department of Internal Medicine I, Bonn University
Bonn, Germany