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Clinical Trials/NCT00234975
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

Sponsor
AbbVie (prior sponsor, Abbott)
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (11)

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