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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00234975
First received: September 13, 2005
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    Changes in liver functions enzyme.


Secondary Outcome Measures:
  • 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


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234975

Locations
Puerto Rico
Site Reference ID/Investigator# 4119
Bayamon, Puerto Rico, 00961
Site Reference ID/Investigator# 4118
Bayamon, Puerto Rico, 00960
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)
Investigators
Study Director: Carlos R Rivera-Vazquez, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00234975     History of Changes
Other Study ID Numbers: PUER-02-003
Study First Received: September 13, 2005
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Lopinavir
Ritonavir
Phase 4
HIV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Lopinavir
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014