An open, prospective study to compare the safety and efficacy of raltegravir vs. atazanavir / ritonavir, both in combination with tenofovir DF and emtricitabine, in the treatment of HIV-infection in ART naive subjects with HCV co-infection - not available

• Conditions: HIV disease

• Registration Number: EUCTR2009-015904-24-DE
• Lead Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-12
• Last Update Posted: 21 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 metabolizd via the cytochrome P450 system with a narrow therapeutic PK-range such as astemizole, terfenadine, cisapride, pimozide, chinidine, bepridile, triazolam, midazolam, ergotamine, dihydroergotamine, ergometrine, methyl-ergomethrine. 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
- ALT = 5 fold the upper limit of norm
- creatinine clearance < 70 ml / min according to Cockcroft-Gault
- serum phosphate < 2.0 mg/dl
- chronic kidney disease
- diabetes mellitus
- active use of illicit drugs
- pregnancy, brest-feeding (not recommended for HIV-infected mothers because of risk of HIV transmission to the new-born)
- any medical condition that in the view of the investigator is not suitable for participation in a clinical trial
-participation in another clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified