Safety of Lopinavir/Ritonavir (Kaletra) in HIV/HCV Co-infected Subjects vs Baseline Liver Biopsy Metavir Score
Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infection
Intervention: Lopinavir/Ritonavir (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AbbVie (prior sponsor, Abbott) Official(s) and/or principal investigator(s): Carlos R Rivera-Vazquez, MD, Study Director, Affiliation: AbbVie
Summary
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.
Clinical Details
Official title: Evaluation of Clinical Response and Safety in HIV Positive Subjects Co-infected With Hepatitis C Treated With a Kaletra Containing HAART Regimen
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Primary Outcome Measure
Secondary outcome: Secondary Outcome Measures
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Site Reference ID/Investigator# 4118, Bayamon 00960, Puerto Rico
Site Reference ID/Investigator# 4119, Bayamon 00961, Puerto Rico
Site Reference ID/Investigator# 6298, Juana Diaz 00795, Puerto Rico
Site Reference ID/Investigator# 6284, Las Piedras 00771, Puerto Rico
Site Reference ID/Investigator# 4101, Mayaguez 00680, Puerto Rico
Site Reference ID/Investigator# 4116, Playa de Ponce 00731, Puerto Rico
Site Reference ID/Investigator# 4099, Ponce 00731, Puerto Rico
Site Reference ID/Investigator# 4117, Ponce 00717-1563, Puerto Rico
Site Reference ID/Investigator# 4086, Rio Piedras 00926, Puerto Rico
Site Reference ID/Investigator# 4080, San Juan 00908, Puerto Rico
Site Reference ID/Investigator# 4100, Santurce 00909, Puerto Rico
Additional Information
Starting date: October 2002
Last updated: January 2, 2013
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