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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00234975
First Posted: October 10, 2005
Last Update Posted: January 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
September 13, 2005
October 10, 2005
January 3, 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 ]
Changes in liver functions enzyme.
Not Provided
Complete list of historical versions of study NCT00234975 on ClinicalTrials.gov Archive Site
Secondary Outcome Measures [ Time Frame: Baseline, Week 4, Week 8, Week 16 and Week 24 ]
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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico
United States
 
NCT00234975
PUER-02-003
No
Not Provided
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Carlos R Rivera-Vazquez, MD AbbVie
AbbVie
January 2013

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