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Safety of Lopinavir/Ritonavir (Kaletra) in HIV/HCV Co-infected Subjects vs Baseline Liver Biopsy Metavir Score

This study has been completed.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier:
First received: September 13, 2005
Last updated: January 2, 2013
Last verified: January 2013

September 13, 2005
January 2, 2013
October 2002
January 2008   (final data collection date for primary outcome measure)
Primary Outcome Measure [ Time Frame: Baseline, Week 4, Week 8, Week 16 and Week 24 ] [ Designated as safety issue: No ]
Changes in liver functions enzyme.
Not Provided
Complete list of historical versions of study NCT00234975 on Archive Site
Secondary Outcome Measures [ Time Frame: Baseline, Week 4, Week 8, Week 16 and Week 24 ] [ Designated as safety issue: No ]
Changes in HIV viral load, CD4/CD8 cell count, and Hepatitis C viral load
Not Provided
Not Provided
Not Provided
Safety of Lopinavir/Ritonavir (Kaletra) in HIV/HCV Co-infected Subjects vs Baseline Liver Biopsy Metavir Score
Evaluation of Clinical Response and Safety in HIV Positive Subjects Co-infected With Hepatitis C Treated With a Kaletra Containing HAART Regimen
The purpose of this study is to evaluate clinical response and safety of a Kaletra containing antiretroviral treatment regimen in HIV positive subjects with HCV coinfection.
Not Provided
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
Drug: Lopinavir/Ritonavir
400 mg/ 100 mg BID. Both arms use Kaletra 400/100 mg BID, plus NRTI chosen by the investigator
Other Name: ABT-378, lopinavir/ritonavir, Kaletra
  • Active Comparator: HCV +
    Intervention: Drug: Lopinavir/Ritonavir
  • Active Comparator: HCV -
    Intervention: Drug: Lopinavir/Ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented HIV positive.
  • At least 18 years of age.
  • Does not exhibit evidence of acute illness (especially any acute liver disease, except hepatitis C)
  • Subject has not been treated for an active opportunistic infection within 30 days of the baseline visit.
  • Subject Has a Karnofsky Score greater than or equal to 70.
  • Subject does not require and agrees not to take, for the duration of the study, any of the following medications that are contraindicated with Kaletra: astemizole, terfenadine, midazolam, triazolam, cisapride, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and methylergonovine), pimozide, propafenone and flecainide. Rifampin, a potent enzyme inducer, should not be administered with the study medication, because of the possibility of significant decreases in Kaletra concentration during concurrent administration.
  • The subject agrees not to take any medication, including over-the-counter medicine, alcohol, recreational drugs or herbal preparations without the knowledge and permission of the principal investigator.
  • Subject had laboratory testing within the previous three months and the most recent testing demonstrates all of the following: Hemoglobin> 8.0 g/dL; absolute neutrophil count > 750 cells/mL; Platelet count > 20,000/mL; ALT or AST </=10 x upper limit of normal (ULN); Creatinine< 1.5 x ULN; Triglycerides </=750 mg/dL.
  • Subjects have no evidence of grade III or IV adverse event or laboratory abnormality (except for LFTs).

Exclusion Criteria:

No exclusion criteria.

18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Puerto Rico
United States
Not Provided
Not Provided
AbbVie (prior sponsor, Abbott)
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Carlos R Rivera-Vazquez, MD AbbVie
January 2013

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