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

HIV Infection Clinical Trial

Official title:

Evaluation of Clinical Response and Safety in HIV Positive Subjects Co-infected With Hepatitis C Treated With a Kaletra Containing HAART Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234975
• Other study ID #: PUER-02-003
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: January 2, 2013
• Start date: October 2002
• Est. completion date: January 2008

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• Lopinavir/Ritonavir
400 mg/ 100 mg BID. Both arms use Kaletra 400/100 mg BID, plus NRTI chosen by the investigator

Locations

Country	Name	City	State
Puerto Rico	Site Reference ID/Investigator# 4118	Bayamon
Puerto Rico	Site Reference ID/Investigator# 4119	Bayamon
Puerto Rico	Site Reference ID/Investigator# 6298	Juana Diaz
Puerto Rico	Site Reference ID/Investigator# 6284	Las Piedras
Puerto Rico	Site Reference ID/Investigator# 4101	Mayaguez
Puerto Rico	Site Reference ID/Investigator# 4116	Playa de Ponce
Puerto Rico	Site Reference ID/Investigator# 4099	Ponce
Puerto Rico	Site Reference ID/Investigator# 4117	Ponce
Puerto Rico	Site Reference ID/Investigator# 4086	Rio Piedras
Puerto Rico	Site Reference ID/Investigator# 4080	San Juan
Puerto Rico	Site Reference ID/Investigator# 4100	Santurce

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measure	Changes in liver functions enzyme.	Baseline, Week 4, Week 8, Week 16 and Week 24	No
Secondary	Secondary Outcome Measures	Changes in HIV viral load, CD4/CD8 cell count, and Hepatitis C viral load	Baseline, Week 4, Week 8, Week 16 and Week 24	No

External Links

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