Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT01225705
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01225705
Study Brief:
Protocol Section:
NCT01225705