NCT00234975CompletedPhase 4
Evaluation of Clinical Response and Safety in HIV Positive Subjects Co-infected With Hepatitis C Treated With a Kaletra Containing HAART Regimen
AbbVie (prior sponsor, Abbott)11 sites in 1 country86 target enrollmentStarted: October 2002Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 86
- Locations
- 11
- Primary Endpoint
- Primary Outcome Measure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
HCV +
Active Comparator
Intervention: Lopinavir/Ritonavir (Drug)
HCV -
Active Comparator
Intervention: Lopinavir/Ritonavir (Drug)
Outcomes
Primary Outcomes
Primary Outcome Measure
Time Frame: Baseline, Week 4, Week 8, Week 16 and Week 24
Changes in liver functions enzyme.
Secondary Outcomes
- Secondary Outcome Measures(Baseline, Week 4, Week 8, Week 16 and Week 24)
Investigators
Study Sites (11)
Loading locations...
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