Safety Study of Raltegravir in HIV/HCV Co-infected Patients
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ClinicalTrials.gov Identifier: NCT01225705 |
Recruitment Status
:
Withdrawn
(no pts recruited)
First Posted
: October 21, 2010
Last Update Posted
: June 3, 2015
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Hepatitis C | Drug: raltegravir Drug: Atazanavir/ritonavir | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Raltegravir
45 patients will receive open label raltegravir, in addition to the common backbone tenofovir and emtricitabine
|
Drug: raltegravir
Patients will be randomized 1:1 to either the experimental or the active control arm
|
Active Comparator: Atazanavir/ritonavir
45 patients will receive open label atazanavir/ritonavir
|
Drug: Atazanavir/ritonavir
Patients will be randomized 1:1 to either the experimental or the active control arm
|
- Primary objective
- there is no difference in the rate of grade 1/2, or 3/4 ALT elevations
- there is a higher incidence of grade 1 - 4 hyperbilirubinemias in the ATV/r arm
- Secondary objectivesOther parameters of safety and efficacy will be compared between both arms

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01225705
Germany | |
Auguste Viktoria Hospital (AVK) | |
Berlin, Germany | |
Praxiszentrum Kaiserdamm | |
Berlin, Germany | |
Private Practice Dupke, Carganico, Baumgarten | |
Berlin, Germany | |
Department of Internal Medicine I, Bonn University | |
Bonn, Germany | |
University of Essen | |
Essen, Germany | |
Infektiologikum Frankfurt | |
Frankfurt / Main, Germany | |
University of Frankfurt | |
Frankfurt / Main, Germany | |
Infektionsmedizinisches Centrum Hamburg (ICH) | |
Hamburg, Germany |
Responsible Party: | Rheinische Friedrich-Wilhelms-Universität Bonn, Germany, Bonn University |
ClinicalTrials.gov Identifier: | NCT01225705 History of Changes |
Other Study ID Numbers: |
UKB-2009-MED-I-JKR-01 2009-015904-24 ( EudraCT Number ) |
First Posted: | October 21, 2010 Key Record Dates |
Last Update Posted: | June 3, 2015 |
Last Verified: | October 2010 |
Additional relevant MeSH terms:
Hepatitis C Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Hepatitis Liver Diseases Digestive System Diseases Ritonavir Atazanavir Sulfate Raltegravir Potassium Emtricitabine HIV Protease Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors HIV Integrase Inhibitors Integrase Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |