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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 - 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

Page last updated: August 23, 2015

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