Clinical Trials


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

This study has been completed
AbbVie (prior sponsor, Abbott)

Information provided by (Responsible Party)
AbbVie Identifier

First received: September 13, 2005
Last updated: January 2, 2013
Last Verified: January 2013
History of Changes


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.

Condition Intervention Phase
HIV Infection

Drug : Lopinavir/Ritonavir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Clinical Response and Safety in HIV Positive Subjects Co-infected With Hepatitis C Treated With a Kaletra Containing HAART Regimen

Further study details as provided by AbbVie:

Primary Outcome Measures

  • Primary Outcome Measure [ Time Frame: Baseline, Week 4, Week 8, Week 16 and Week 24 ]
    Changes in liver functions enzyme.
Secondary Outcome Measures:
  • 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

Enrollment: 86
Study Start Date: October 2002
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: HCV +

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 -

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


Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


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 Subjects have no evidence of grade III or IV adverse event or laboratory abnormality
(except for LFTs).

Exclusion Criteria:

    No exclusion criteria.

contacts and locations

Contacts and Locations

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Please refer to this study by its identifier: NCT00234975


Puerto Rico
Site Reference ID/Investigator# 4118
Bayamon, Puerto Rico, 00960
Site Reference ID/Investigator# 4119
Bayamon, Puerto Rico, 00961
Site Reference ID/Investigator# 6298
Juana Diaz, Puerto Rico, 00795
Site Reference ID/Investigator# 6284
Las Piedras, Puerto Rico, 00771
Site Reference ID/Investigator# 4101
Mayaguez, Puerto Rico, 00680
Site Reference ID/Investigator# 4116
Playa de Ponce, Puerto Rico, 00731
Site Reference ID/Investigator# 4117
Ponce, Puerto Rico, 00717-1563
Site Reference ID/Investigator# 4099
Ponce, Puerto Rico, 00731
Site Reference ID/Investigator# 4086
Rio Piedras, Puerto Rico, 00926
Site Reference ID/Investigator# 4080
San Juan, Puerto Rico, 00908
Site Reference ID/Investigator# 4100
Santurce, Puerto Rico, 00909

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)


Study Director: Carlos R Rivera-Vazquez, MD AbbVie
More Information

More Information

Additional Information:

Related Info

Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT00234975   History of Changes  
Other Study ID Numbers: PUER-02-003  
Study First Received: September 13, 2005  
Last Updated: January 2, 2013  

Keywords provided by AbbVie:

Phase 4

Additional relevant MeSH terms:
HIV Infections
Lopinavir processed this data on May 28, 2020
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