Safety Study of Raltegravir in HIV/HCV Co-infected Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University Hospital, Bonn.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Dr. Axel Baumgarten, Berlin
Dr. Christoph Stephan, Frankfurt/M
Dr. Stefan Esser, Essen
Dr. Keikawus Arastéh, Berlin
Prof. Dr. Hans-Jürgen Stellbrink, Hamburg
Dr. Thomas Lutz, Frankfurt/M
Dr. Jörg Gölz , Berlin
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01225705
First received: October 20, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted

October 20, 2010
October 20, 2010
October 2010
Not Provided
Primary objective [ Designated as safety issue: Yes ]
  1. there is no difference in the rate of grade 1/2, or 3/4 ALT elevations
  2. there is a higher incidence of grade 1 - 4 hyperbilirubinemias in the ATV/r arm
Same as current
No Changes Posted
Secondary objectives [ Designated as safety issue: Yes ]
Other parameters of safety and efficacy will be compared between both arms
Same as current
Not Provided
Not Provided
 
Safety Study of Raltegravir in HIV/HCV Co-infected Patients
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.

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 plus a ritonavir boosted protease inhibitor or a non-nucleoside reverse transcriptase inhibitor.

The non-nucleoside reverse transcriptase inhibitors licensed for naïve patients - nevirapine and efavirenz - have both been asociated with increased rates of hepatotoxicity (nevirapine) and CNS toxicity (efavirenz) in HIV/HCV co-infected patients. Although PI-based therapy has dramatically reduced morbidity and mortality, it has been limited by complex dosing regimens and toxicities, leading to adherence challenges. Varying degree of liver insufficiency may necessitate pharmacokinetic monitoring of the protease inhibitor and may necessitate dose adjustments. In HIV/HCV co-infected patients HAART based on another class of antiretrovirals than NNRTI or PI may thus offer advantages with regard to adverse events and thus long-term efficacy.

The overall intention of this trial is to examine in a non-inferiority design the safety and efficacy of a raltegravir based HAART with a standard-of-care HAART in HIV-/HCV co-infected patients. The standard of care used in this study will be atazanavir/ritonavir. All patients will in addition receive a fixed combination of tenofovir and emtricitabine.

The primary end-point is the rate of hepatotoxic events, defined by ALT elevations.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • Hepatitis C
  • Drug: raltegravir
    Patients will be randomized 1:1 to either the experimental or the active control arm
  • Drug: Atazanavir/ritonavir
    Patients will be randomized 1:1 to either the experimental or the active control arm
  • Experimental: Raltegravir
    45 patients will receive open label raltegravir, in addition to the common backbone tenofovir and emtricitabine
    Intervention: Drug: raltegravir
  • Active Comparator: Atazanavir/ritonavir
    45 patients will receive open label atazanavir/ritonavir
    Intervention: Drug: Atazanavir/ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact: Jürgen K Rockstroh, Professor +49-228-287 ext 16558 juergen.rockstroh@ukb.uni-bonn.de
Contact: Brigitta Späth, MTA +49-228-287 ext 9556 brigitta.spaeth@ukb.uni-bonn.de
Germany
 
NCT01225705
UKB-2009-MED-I-JKR-01, 2009-015904-24
No
Rheinische Friedrich-Wilhelms-Universität Bonn, Germany, Bonn University
University Hospital, Bonn
  • Dr. Axel Baumgarten, Berlin
  • Dr. Christoph Stephan, Frankfurt/M
  • Dr. Stefan Esser, Essen
  • Dr. Keikawus Arastéh, Berlin
  • Prof. Dr. Hans-Jürgen Stellbrink, Hamburg
  • Dr. Thomas Lutz, Frankfurt/M
  • Dr. Jörg Gölz , Berlin
Not Provided
University Hospital, Bonn
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP