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

NCT01225705 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-06-03

No results posted yet for this study

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 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.

Conditions

  • HIV
  • Hepatitis C

Interventions

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

Sponsors & Collaborators

  • Dr. Axel Baumgarten, Berlin

    collaborator UNKNOWN

  • Dr. Christoph Stephan, Frankfurt/M

    collaborator UNKNOWN

  • Dr. Stefan Esser, Essen

    collaborator UNKNOWN

  • Dr. Keikawus Arastéh, Berlin

    collaborator UNKNOWN

  • Prof. Dr. Hans-Jürgen Stellbrink, Hamburg

    collaborator UNKNOWN

  • Dr. Thomas Lutz, Frankfurt/M

    collaborator UNKNOWN

  • Dr. Jörg Gölz , Berlin

    collaborator UNKNOWN

  • University Hospital, Bonn

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01225705 on ClinicalTrials.gov