Clinical trial NCT00234975: Safety of Lopinavir/Ritonavir (Kaletra) in HIV/HCV Co-infected Subjects vs Baseline Liver Biopsy Metavir Score
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection
Keywords: Lopinavir
Ritonavir
Phase 4
HIV
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: Baseline, Week 4, Week 8, Week 16 and Week 24
Secondary outcomes:
measure: Secondary Outcome Measures
timeFrame: Baseline, Week 4, Week 8, Week 16 and Week 24
Other outcomes:
Locations:
city: Bayamon
country: Puerto Rico
facility: Site Reference ID/Investigator# 4118
city: Bayamon
country: Puerto Rico
facility: Site Reference ID/Investigator# 4119
city: Juana Diaz
country: Puerto Rico
facility: Site Reference ID/Investigator# 6298
city: Las Piedras
country: Puerto Rico
facility: Site Reference ID/Investigator# 6284
city: Mayaguez
country: Puerto Rico
facility: Site Reference ID/Investigator# 4101
city: Playa de Ponce
country: Puerto Rico
facility: Site Reference ID/Investigator# 4116
city: Ponce
country: Puerto Rico
facility: Site Reference ID/Investigator# 4117
city: Ponce
country: Puerto Rico
facility: Site Reference ID/Investigator# 4099
city: Rio Piedras
country: Puerto Rico
facility: Site Reference ID/Investigator# 4086
city: San Juan
country: Puerto Rico
facility: Site Reference ID/Investigator# 4080
city: Santurce
country: Puerto Rico
facility: Site Reference ID/Investigator# 4100
Study officials:
affiliation: AbbVie
name: Carlos R Rivera-Vazquez, MD
role: STUDY_DIRECTOR
References: